Thursday, July 31, 2008
I sure would like to meet the dog(s) Ann Selzer knows that are capable of going through and answering a whole telephone poll- that's worthy of front page coverage in and of itself!
One nice thing about the story was that a recording of a sample PPP poll was posted on the WSJ website. If you've ever been curious about the voice of our polls, listen here.
By my count, that makes nine Canucks who will attempt to take the green flag in the main event at Circuit Gilles Villeneuve. Can't wait!
Severe thunder storms with heavy rains gave way to sunny skies as the Shaw Crew arrived at Flamboro Speedway for the 40 lap Gary Elliott Anniversary Special. Gary and Nonie Elliott started racing in May of 1969 and over the next four decades would accumulate three seasons in the Mini Stocks and thirty-three in the Vintage Modifieds before joining the Late Models in 2005.
The Elliotts wanted a night set aside where they could say thanks to every segment of the racing community - the fans, children, racers, sponsors and the race track owners. Six bicycles were given away as part of the evening’s festivities – two of which were supplied by Shaw Motorsports on behalf of Roof Trusses and Components and the young winners were very happy due to the generosity of these sponsors. The Late Model drivers democratically decided that the extra purse monies for the night be donated to the charity of Gary’s choice which happened to have representatives in attendance. Dale Losch, from Cross World was presented with $760 during the intermission
The crew decided to try a little of the Delaware setup in the car for the first practice, however it was not as comfortable as they thought it would be. A chassis adjustment was made and the car was much better for the second practice.
The #82 Roof Trusses and Components Fusion started 3rd in the heat race and when the #10 who was ahead of him got a little loose, Jason was quick to make the move inside and take the position. The #48 and #42 got together at the back of the field to bring out the caution and that put Jason on the outside of the #36 for the restart.
After one lap of side by side racing, Jason got past the #36 and then started to pull away. With 3 laps to go, Jason managed to pull away from the #36 and took the checkered flag for the heat win. Jason was lined up 12th for the 40 lap feature and as the cars entered the track, they were stopped on the front stretch to allow Gary Elliott time to get out of his car and present track owners John and Frank Casale with a special plaque. After running 3 laps on the outside of the #8, Jason fell in behind him as the cars in front of him were loose and not moving as well as the lower lane.
Once down on the bottom, Jason quickly moved forward into 10th just prior to the #27,#3 and #42 getting together coming out of turn 4. Unfortunately, Jason was not able to get stopped in time as a little help from behind by the #52, pushed the #82 into the stopped cars causing minor damage to the right rear. The Nation Fire Equipment Ford restarted 13th behind the #3 and when the next caution came out for the #10 who had spun on lap 9, was up to 12th. On the restart, Jason was able to get past the #3, #27 and #88 into 9th. The #56 pulled off the track with an overheating problem moving the #82 into 8th on lap 15.
On the restart Jason followed the #48 past the #27 into 7th. Just before the half way mark, the #36 got a good run on the #37 and Gary Elliott was now leading the race. The #52 hit the wall on lap 22 and this pushed the rear end out of alignment causing him to spin out in the next corner bringing out the caution and putting the #82 into 6th. Jason got past the #48 on lap 26 into 5th and was now behind the #86. With 10 laps to go, the #36 had a 5 car length lead over his son David in the #37 car who had his hands full defending his position from the #8. With 5 laps to go, the top 5 pulled away from the rest of the field and remained in that order to finish with the #36 taking the victory followed by the #37, #8, #86 and then the #82 in 5th.
In other racing news, Billy Schwartzenburg in his #82 Mini-Sock went for a wild ride in his heat race. Billy was the victim of a chain reaction accident that saw him get turned into the wall at the exit of turn four and the front end climbed the wall, flipping the car on to it’s roof. Billy was fine, however his mother was an emotional wreck and the car received extensive damage beyond repair. Ken Spira, Dave Hagedorn and the Schwartzenburg family went to work putting Billy’s motor, seat and set up into his brother Rick’s #72 car so he could continue to hold or improve on his 4th place position in the Flamboro points race. Billy is a 15 year old from Guelph and is the primary mini-stock sponsored by Spira Fire Protection.
Next up for the Shaw Team, is the Kid’s Ride night at Flamboro Speedway on Saturday August 2nd. The pits are scheduled to open at 4:00 pm, main gates at 5 and racing is to get underway at 6:30. Kid’s rides are from 5 - 6.
From Ken Spira / Shaw Motorsports
For more information on Pierre Bourque, check out http://www.pierrebourque.net/.
But even the dog days of summer can't stop us from taking note of this one: Amgen is giving global rights (except for Japan) to a clinical stage neuropathic pain project to...(drum roll please) Johnson & Johnson.
Considering the companies have spent the past two decades in an endless series of disputes, arbitration and litigation over their last licensing deal, involving a little product called EPO, that is news indeed.
If there ever was a case of adversity bringing people closer together, this is it.
Amgen and J&J have both said that their working relationship has been improved by the all-out effort to save the EPO franchise from regulatory and reimbursement challenges. So much so that Amgen CEO Kevin Sharer told the JP Morgan conference in January that “I never thought I would say this, but this circumstance has made us and J&J quite effective partners.” That may not be much of a silver lining from everything that has befallen EPO--but it sure is hard to imagine the two companies reaching this agreement two years ago, when the only place their executives were likely to exchange confidential information was in court.
Amgen's willingness to deal with J&J also suggests that it really means business when it talks about winnowing down its pipeline. In fact, Amgen has already shown it means business, in fact; Japanese rights to the neuropathic pain compound were already sold as part of a large partnership with Takeda in Japan.
Now the terms. Amgen receives $50 million up front--or a refund of one-quarter of the $200 million Amgen paid to settle antitrust litigation with J&J over EPO last month. Amgen will also receive development milestones of up to $385 million. There are additional commercial milestones and a sales royalty too.
And, no, there is no copromotion agreement.
Strobel also saw action in response to the May Cyclone Nargis disaster in Myanmar/Burma whose devastation has left an estimated 140,000 dead. He helped organization deployment of disaster response volunteers amidst Myanmar moratorium on visas. The Pittsburgh native will spend some time in the city over the course of August and then return to Thailand where he spends 11 months out of the year.
Attorney General spokesperson Nils Frederiksen says it is innappropriate for these people to use MySpace. Online predators could use it like an online shopping network to lure their prey, he remarks.
Frederiksen says none of these offenders have violated court orders with their accounts so far, but investigators need to look at each case individually. He suspects other sex offenders use an alias, and the Attorney General hopes MySpace and law enforcement will cooperate with further investigation in finding those people.
to the NASCAR Sprint Cup Series Race & NASCAR Nationwide Series Race plus a Pit Pass and Hospitality Tent on Sunday
Richmond - September 4-8 - SOLD OUT!!
Martinsville - October 16-20 - MotorSports SuperCoach SOLD OUT!! ... BUT Additional seats still available on our 54 passenger Highway Coach - $500 PP Twin
But we are boldly predicting a big finish to the year, in part for an unlikely reason: FDA's new mandatory post-marketing safety tools that allow it to compel labeling changes, Phase IV studies, and--most significantly--Risk Evaluation & Mitigation Strategies.
The REMS authorities kicked in in March, and we’re learning a bit more about how FDA is using its new tools. And while there was much nervous anticipation as industry braced for FDA to start wielding its new (now mandatory!) risk management tools, the reality has been pretty positive.
There have been a lot of required post-marketing studies, and relatively few full-fledged REMS programs for new molecular entities. In fact, it looks like REMS is turning out to be a way to revive applications that once looked dead (or at least terminally “approvable”).
FDA has applied the new drug safety tools to three new molecular entities so far this year--CV Therapeutics/Astellas’ Lexiscan, UCB’s Cimzia, and GSK/Adolor's Entereg. And in every case the sponsor has been thrilled to have a product to market at all. (Read about some of the early experiences with REMS here.)
That's just the tip of the iceberg.
A REMS is definitely in the works for GSK’s platelet growth stimulator Promacta (eltrombopag), and Lilly has hinted that its antiplatelet agent Effient (prasugrel), partnered with Daiichi Sankyo, could have some form of a REMS – although Lilly is suggesting it would be on the less intensive end of the spectrum. Both NDAs received three-month review extensions, an emerging pattern for reviewing REMS proposals.
The premature press release snafu for Amgen’s Nplate also revealed that a REMS program called NEXUS is slated to accompany the approval of romiplostim, a fusion protein that, like Promacta, treats idiopathic thrombocytopenic purpura.
FDA’s new authority opens a new parlor game of guessing which applications could be REMS-worthy. According to Pharmaceutical Approvals Monthly, there are at least 30 NMEs pending with user fee deadlines coming up during the second half of the year. Which ones could have a REMS?
Pfizer/Ligand’s Fablyn (lasofoxifene) for treatment of post-menopausal osteoporosis: The post-Evista SERM class has had trouble clearing the final approval hurdle at FDA, in part because of safety issues. Prior to the Fablyn submission Jan. 15, lasofoxifene (then Oporia) was found not approvable for prevention of PMO in 2005, and then not approvable again, for treatment of vaginal atrophy, in 2006. Wyeth’s SERM Viviant (bazedoxifene) has been approvable twice for osteoporosis prevention and once for treatment. Further data was requested on stroke and venous thrombotic events.
Johnson & Johnson’s paliperidone palmitate: Can the once-monthly version of J&J’s antipsychotic Invega do better than the “not approvable” letter issued to Lilly’s fellow atypical antipsychotic Zyprexa for its once-monthly depot, Zyprexa LAI? The long-acting injection formulations may have a new risk of excessive sedation. Given J&J’s flagging public enthusiasm for the project, and its renewed interest in Alkermes’ claim that its technology can now support a once-monthly version of Risperdal Consta, does J&J really care?
Schering-Plough’s Bridion (sugammadex): The prospect of the first selective relaxant binding agent, which was just approved in the EU, has stirred up the anesthesia market. But signals from FDA could indicate caution. The agency extended the user fee goal by three months to review a hypersensitivity study. And in an unusual set of events, a March advisory committee supported approval, but could not make a formal recommendation because data had been submitted shortly before the panel met.
Moving beyond the bounds of pending NMEs opens a plethora of potential REMS. One likely candidate is Cephalon’s fentanyl product Fentora. The advisory committee review of a breakthrough cancer pain indication for the approved drug focused on the inadequacies of the existing RiskMAP. Other extended-release pain products, like Labopharm’s tramadol formulation, are also potential REMS contenders.
Review the list yourself and play along at home. What else looks REMS worthy to you?
Not sure why it was ever in doubt, but we received the following note from Wonderland Speedway regarding their Friday, Aug. 1 show: "Good news! racing at Wonderland speedway is a go for Aug 1, 2008. See everyone at the track!"
The Sportsman cars last competed at Ohsweken on June 27 when 32 of the best Sportsman drivers in the region signed in to do battle for a $1,000 winner's cheque. At the end of the night, it was surprise winner Brandon Easey of St. Catharines visiting victory lane for the first time in his career, followed by local driver Robbie Rounce, Jim Johnstone, Mat Williamson, and Brad Rouse rounding out the top 5.
In a unique twist, the Lucas Oil series points are tallied using feature finishes, and the driver with the lowest total will win the championship. The series standings are very tight heading into Ohsweken, with Tyler McPherson leading Chad Chevalier by just 1 marker, as McPherson has yet to finish outside the top 5 in the first 3 series races. McPherson finished 5th in round 1 at Genesee on June 14, 2nd at Merrittville on June 21, and 4th at Humberstone on July 6.
Chevalier, meanwhile, took 3rd place finishes in each of the first 2 rounds, but finished 6th at Humberstone, putting him 1 spot behind McPherson. When the 2 drivers last visited Ohsweken on June 27, it was McPherson with the upper hand over Chevalier when the checkered flag fell, as Tyler came from 12th on the grid to finish 6th, while Chevalier started 24th and finished 9th.
Both drivers will be looking to improve on those finishes on Friday, but BJ Willard, Mat Williamson, and James Michael Friesen round out the top 5 in series points and figure to give the 2 front runners a run for their money. Friesen is the only driver in the top 5 who has collected a win in the first 3 events, a feat which he accomplished at Humberstone. Williamson, meanwhile, had all eyes on his #6 the last time he visited Ohsweken as he started 25th on a promoter's option and charged all the way to 4th when the green flag fell.
New York driver Rob Pratt will also be one to watch this Friday, as the former Ohsweken track champ is always fast on the 3/8's mile, and would likely have been in contention for the win on June 27th if damage in his heat race had not ended his night prematurely.
Always a fan favourite at Ohsweken, the ESSO Mini-Stocks will be in the limelight on Friday night when they contest the annual 42-lap Art Hill Memorial race. This year's event will see 26 starters battling for the coveted Art Hill victory and the $1,000 that goes along with it, in what is sure to be a hotly contested event. Dave Bailey won last year's edition of the event, but has since moved up to the Thunder Stock division, although he did compete in the Mini-Stocks at the start of this season as well, and could return to defend his crown this week.
Heading into the week, 2007 track champ Abel Castelein enjoys a 66 point lead over Mitchell Brown in the standings, and is riding a 2-race win streak. The fight for 2nd is heating up however, as the 2nd through 5th place drivers are seperated by just 7 points, with Brown's 2 feature wins being the main difference. After his 2 recent race wins are counted in the handicapping system, Castelein will need to come from the middle of the pack if he hopes to extend his winning streak and take home the Art Hill victory.
Following Brown in the points are Rick Emberson, Kevin Hilborn, and Mark Thorne, all of whom have yet to take a checkered flag this season, and would like nothing more than to take the Art Hill win.
In the ESSO Thunder Stock division, points leader Cody McPherson got back on track with a feature win the last time out, after a flat tire derailed his season-long streak of top-3 finishes the week before. Ryan Dinning, Terry Osmond, Glen Leinen, and Brian Pescetti round out the top 5 in Thunder Stock points, while defending track champ Brad Bacher has not had the season he intended, slipping to 10th in the standings after he finished 17th in the most recent event.
The Thunder Stocks have been a very exciting and competitive division all season at Ohsweken and entertained the fans with spectacular racing in their last event, with more of the same expected this Friday.
The Friday Night Fun Stocks division continues to grow and become more competitive with each passing week, and the racing action has been especially good in each of the last two events as the drivers have become more comfortable on the smaller oval located in Ohsweken's infield. In the last event, Lee Hils extended his points lead by taking his 4th feature win of the season, but Chris Hils finished 4th that night to keep Lee in sight, and sits just 12 points behind, while Karl Sault has won 2 features this season and is still within striking distance in 3rd, 38 points back of the lead.
Exchange/refund information for for ticket holders from the rained-out World of Outlaws events last week is now posted on the Ohsweken Speedway website at www.OhswekenSpeedway.com.
Please visit the website to view the different options available. Dawn Pelkie will be at Ohsweken Speedway this Friday, August 1 from 5:30p.m. - 8:00p.m. to handle ticket exchanges for anyone who paid cash for their tickets at the speedway.
One of the options available to ticket holders is an exchange for tickets to the Canadian Sprint Car Nationals, an event which is fast approaching, scheduled for September 12 and 13. Plenty of reserved seats remain available for each night of this huge event, which will see more than 70 of the best 360 sprint car drivers from Ontario, Quebec, New York, Pennsylania, Ohio, Michigan, Indiana, and beyond all competing for the $8,000 winner's cheque and the right to be called the winner of the 4th annual Canadian Sprint Car Nationals. Visit www.OhswekenSpeedway.com and then call 1-888-720-RACE to get your tickets.
Ohsweken Speedway's Friday Night Thunder resumes this Friday, August 1 when Outhouse Designs presents the Lucas Oil Sportsman Shootout, and ESSO Mini-Stock Art Hill Memorial Race, plus ESSO Thunder Stocks and Friday Night Fun Stocks. Friday Night Thunder at Ohsweken offers affordable family entertainment just a short drive away from most Mid-Western Ontario locations. Friday Night Thunder Adult General Admission is $10, while Seniors and Students are $8, and Kids age 12 and under are FREE! Please visit www.OhswekenSpeedway.com for more information. Spectator gates open @ 6:00p.m., with the first race taking the green flag at 7:45p.m. this Friday, August 1!
Washington Republicans 43
Washington Democrats 35
Raleigh Democrats 15
Raleigh Republicans 7
When North Carolina voters think about corruption, only 22% of them associate it most with Raleigh. That is a strong indicator of how difficult it will be for Pat McCrory and Republican legislative candidates to win this fall by railing against the culture in Raleigh. Civitas polls in the last two months have shown that many voters don't even know which party is in charge in Raleigh, and that they trust Democrats more than Republicans to bring change to state government.
In 2006 Democrats in North Carolina made gains at the state level despite the specter of Jim Black's issues because voters were much more aware of Republican transgressions at the federal level. It appears that the GOP here will have difficulty dealing with that reality once again. Average North Carolinians just are not that in tune with some of the things that have gone down in Raleigh over the last few years.
If Republicans really want to win in the state this fall they probably need to refocus their message on issues that really impact voters' daily lives.
Full results here.
BRANTFORD, ON - Doug Brown resumes his NASCAR Canadian Tire Series schedule this coming weekend in Montreal when the all-Canadian stock car racing series joins the NASCAR Nationwide Series on Montreal's Circuit Gilles Villeneuve.
It will the Brantford competitor's first race since July 5th at St. Eustache, Quebec where he earned his third straight top-ten finish after a disappointing start to the season at Cayuga Speedway. The veteran driver of the Haldex-sponsored Dodge elected to skip the recent western segment of the 13-race schedule and is anxious to get back into the action and resume his steady performance improvements prior to the break.
Brown had climbed to tenth-place in the standings following his run at St. Eustache but now finds himself in 19th-place having missed the events in Vernon, BC and Edmonton.
"It was a costly decision in terms of where we are now in the standings (by not going west) but in looking at the results of the western races we may have saved ourselves a lot of money given the motor attrition some of those who went west experienced", Doug remarked in assessing his current position.
Despite his drop in the overall standings he remains optimistic that he can still salvage a top-15 or better position in the standings before the season is over.
"A lot can happen in the remaining seven events, so we'll just attempt to regain our momentum and see what we can muster. "
NASCAR Canadian Tire Series teams will practice Friday morning at the famed circuit on Île Notre-Dame beginning at 8:00 am with qualifying session scheduled for 12:30 pm.
The 23-lap/100 km NCATS event schedule for Saturday morning begins with drivers' presentation at 9:35 followed by the 10:20 race start.
Strong Canadian Contingent in NAPA 200: This year's NASCAR Nationwide Series NAPA 200 will have a strong representation of Canadians vying for spots in the starting field.
Former Formula One and CART driver Jacques Villeneuve, son of Gilles Villeneuve for whom the track was named, has reached agreement with a group of sponsors (Groupe Savoie of Les Résidences Soleil, Schick Canada, L'Équipeur and Marks Work Wearhouse, the UPS Store Canada, Hype Energy Drinks, and Ganotech for his ride in the Braun Racing No. 32 Toyota Camry. Villeneuve has captured championships in both the CART Series in 1995 and Formula 1 two years later. He has also won the 1995 Indy 500.
Patrick Carpentier a regular in NASCAR's premier Sprint Series, captured the pole position for last year's inaugural Canadian event and went on to finish second in the race. Carpentier's Gillett Evernham team decided he would skip the regular Sprint Cup series race in Pocono this weekend to concentrate on the Montreal event. This will be his fifth Nationwide start this season.
D.J. Kennington, currently third in the NASCAR Canadian Tire Series standings, will being double-duty this weekend by driving the No. 81 Mahindra Tractor Dodge in the NASCAR Nationwide Series special. Kennington has already entered 17 of the 24 Nationwide Series events run todate (24th in points) with his best finish being 23rd in Nashville.
Other Canadians expected to enter the Nationwide event are Ron Fellows, Wheeler and Trevor Boys plus current NASCAR Canadian Tire points leader Scott Steckly and veteran Don Thomson, Jr. currently 131 points behind Steckly and a mere 12 points ahead of Kennington.
Prepared By: Ken Spencer // HB Motorsports
Wednesday, July 30, 2008
One Hill, which represents residents in the Hill District, agreed to sign the CBA on May 10th. Since then, Redwood says the other parties involved have been dragging their feet. Both Mayor Luke Ravenstahl and Allegheny County Chief Executive Dan Onorato say they intend to sign the agreement but there may have been some delays due to conflicting summer schedules.
The agreement includes a master plan for development in the Hill, a career center, and funding for a grocery store and community center.
The company and it's rejected investigational atypical antipschotic drug iloperidone appear to be a marker in the ongoing debate over whether FDA is increasingly using a comparative efficacy standard when considering new drug approvals.
“We are disappointed by this response, but will meet with the FDA to discuss this decision further,” Vanda Pharmaceuticals CEO Mihael Polymeropoulos said in a statement after receiving a “non-approvable” letter from FDA for the schizophrenia drug iloperidone, July 29.
Based on comments by FDA's dean of the drug review process, Bob Temple, there may not be much to discuss.
The atypical antipsychotic was licensed from Novartis after the Swiss company dropped it from development. Polymeropoulos previously headed up Novartis' global pharmacogenetics group before founding Vanda in 2003.
The FDA maintained that Vanda had demonstrated the effectiveness of iloperidone at 24 mg/day with efficacy similar to the active comparator, Pfizer’s ziprasidone (Geodon), according to the company. Vanda also claims the agency confirmed a prior study’s results that iloperidone was better than placebo in patients with schizophrenia at doses of 12-16 mg/day and 20-24 mg/day.
But FDA turned the drug away due to its lackluster performance versus Johnson & Johnson’s atypical risperidone (Risperdal). The agency, in its letter, said Vanda would have to conduct an additional trial comparing iloperidone to placebo and including an active comparator such as Risperdal or Eli Lilly’s olanzapine (Zyprexa). The company will also have to generate more safety data for the higher dose.
FDA has been assailed recently for going beyond its statutory obligation of approving and rejecting drugs simply based on its mission rooted in a singular question: do the benefits outweigh the risks? Critics say FDA is adopting a comparative effectiveness standard for me-too drugs.
FDA Office of New Drugs director John Jenkins insists that assertion is absolutely incorrect and that FDA always bases approvals on the benefit/risk question. To read more, click here. However, not everyone at the agency has been nearly as insistent on that issue.
Temple, who oversees the office which regulates psychopharmacologic drugs and also serves as director of FDA's Office of Medical Policy, has warned sponsors of the higher bar for approval in the past for classes where there are already multiple therapeutic options. To read about our warning in 2007, click here.
At a July 30 Institute of Medicine meeting on evidence-based medicine and comparative effectiveness, Temple unexpectedly—and briefly—addressed the iloperidone decision—we think.
“It’s getting much harder to develop the third, fourth, fifth, and sixth member of a class of drugs because when there’s a generic, people are inclined to use the cheap one,” Temple said.
Temple tried to frame comparative effectiveness studies—specifically randomized clinical trials and not literature reviews or observational studies—as the best, and maybe only, way to get those drugs through FDA.
“So to get anyone interested in the next member, you almost have to be able to have some sort of advantage. It could be safety, of course, but I see more interest than ever before because the industry regularly didn’t look at this sort of thing in comparative studies for a fair number of drugs.”
Then he weighed in specifically on what we assume was the iloperidone decision.
“We have taken a couple of steps that I think are interesting. We’ve turned down new antipsychotic drugs because they didn’t seem as effective as the available therapy.”
He continued: “I can’t remember if that ever happened before or whether we didn’t have the [courage] but we did. We decided that it wasn’t good if you’re an acute schizophrenic in the middle of an episode to be treated poorly.”
Those sentiments make it extremely unlikely that Vanda will be able to get an approval without conducting a large, expensive, prospective, head-to-head comparative clinical trial outlined in the FDA letter. Temple made it appear that there would be little room for negotiation.
Now it’s up to Vanda whether they want to use the $65 million in cash on hand plus future rounds of raising capital to do the studies FDA wants.
Let's start with the bad. So far, the number of new molecular entities and novel biologics approved by the Food & Drug Administration in the first half of 2008 is actually lower than it was at this time last year. FDA approved six NMEs by the end of June 2008, one less than the seven NMEs approved by the mid-point of 2007.
And history suggests the second half will look kind of like the first. In recent years, roughly half of the yearly total of NME approvals fall between January and June. In 2007, seven of 16 NMEs were approved by June 30; in 2006, nine of 18 fell in the first six months; and in 2005, seven of 18 NMEs were approved halfway through the year. (For more analysis of FDA’s approval performance at the half, see the July issue of Pharmaceutical Approvals Monthly.)
Given that 2007 ended up being quite possibly the worst year ever for innovative pharmaceutical launches, those are not trends anyone should be excited about. Only 16 NMEs made it through the agency last year, the lowest single-year total in a quarter century--which is before the modern generic drug industry took shape and made new molecules so vital to the health of brand name companies.
So what's the good news? Well, despite the slow start andFDA's recent history of slow finishes, we would be willing to be that the agency will in fact beat last year's NME total.
Why? First off, the agency has at least 30 pending applications for NMEs with user fee deadlines that fall during the second half of the year. (Want the list? Click here to see it, courtesy of Pharmaceutical Approvals Monthly.)
Of course, FDA has officially decided that it no longer has to meet the official user fee deadlines – given the overload of work stemming from the new drug safety legislation on an already strained staff. That certainly complicates any predictions for the rest of the year--but it also means FDA has a handful of applications that are overdue for action. And, it looks to us like the trend is for missed deadlines to end in approvals, rather than requests for more data and new review cycles.
User fee goals have been missed for three NMEs under review by the Division of Cardiovascular and Renal Products alone this year: Cardiome/Astellas’ Kynapid (vernakalant) and Solvay’s Pulzium (tedisamil), both anti-arrhythmics with user fee goal dates in mid-January, and The Medicines Company’s Cleviprex (clevidipine) for acute hypertension in May.
More recently, Theravance announced that the July 21 user fee date for its antibiotic televancin was passing without FDA action. Amgen also announced that the user fee deadline for Nplate was among the cohort of drugs where FDA was consciously missing the PDUFA date (after accidentally releasing a press release that the thrombocytopenia product was being approved).
That means FDA has at least five pending applications where an answer is overdue. We're betting that most of those will end up approved at some point this year.
Then there is the impact of one of the biggest changes to FDA’s review authorities under the new law: the creation of mandatory Risk Evaluation & Mitigation Strategies. Thus far, FDA has used the REMS to breathe life into drugs that were stuck at the agency for years.
We'll talk more about those trends in some upcoming posts, but the bottom line is that we still expect the NME tally this year to come in ahead of last year.
Still, let's keep some perspective: if by some miracle FDA approves all 30 pending NMEs this year, it will end up with a total of 36 overall. More than double last year's tally--but just an average year for the 1990s.
Sadly for the innovative industry, its clear that the best to hope for this year is to recovery from abysmal to the merely dreadful.
New Hampshire Motor Speedway reacts to being left off the 2009 IndyCar sked: "... a slap in the face..."
LOUDON, N.H. (July 30, 2008) – The following is a statement from New Hampshire Motor Speedway Executive Vice President and General Manager Jerry Gappens on the Speedway being omitted from the 2009 IndyCar Series Schedule.
“I’m extremely disappointed for our fans, who have given us very positive feedback about the possible return of IndyCar racing to New Hampshire Motor Speedway. In fact, in a recent poll on our website, nhms.com, nearly 80-percent of our fans said they wanted to see this exciting form of motorsports return. That’s a strong endorsement, and I don’t understand the decision not to include our facility on next year's schedule.
I think it’s a slap in the face to Bruton Smith, our Chairman, and to our company who have both been very supportive of the Indy Racing League since its inception. From a historical perspective, Bob Bahre, the former owner of New Hampshire Motor Speedway, was one of the first to agree to go with the Indy Racing League (IRL) when they split from Championship Auto Racing Teams (CART) in 1995.
I sat in a meeting and watched Bruton ask them for a race here, which they seemed extremely interested in doing, pending scheduling conflicts with Japan. In addition, in that same meeting, they asked him to host the series finale in Las Vegas, which Mr. Smith agreed to and even offered the speedway and financial support for it to happen this year. Having attended that meeting in early June, it’s hard to believe that neither facility is on the new schedule.
The feedback that has been conveyed to me is that they don’t want to add an additional race to the schedule because of the increased cost to the teams. However, I believe that the purse and the strength of adding the seventh largest media market in the country would offset those costs and concerns. I think this market and facility have a lot to offer the team and series sponsors.
I would like to thank Texas Motor Speedway President and General Manager, Eddie Gossage, who on behalf of Speedway Motorsports, made an excellent proposal to the league which included Las Vegas and New Hampshire.
I don’t want to burn any bridges, but I am upset to be excluded. I am a big fan of open-wheel racing, and I strongly admire what the Hulman-George family has done for this sport. I hope that they know they would get an excellent effort from our team here at New Hampshire Motor Speedway in promoting a race in this market. History has proven that this venue provided exciting races. Now, we'll see what happens down the road.”
Jay Ofsanik, a PennDOT safety spokesperson, says the accident reports show a trend. People who sped, were under the influence of alcohol, or did not wear a seat belt, were more likely to die in an accident.
Last year, there were 50 total fatalities. In 2006, there were 35.
Ofsanik says these rates are startling, and that driving slower will reduce the chances of a fatal accident.
Ofsanik also says young people between the ages of 16 to 25 were involved in half of these accidents, probably due to a combination of their inexperience and the preceding trends.
INDIANAPOLIS (July 30, 2008) – The IndyCar Series in DIRECTV HD today announced its 2009 schedule featuring 18 races, including two new destinations, bookend dates for the state of Florida marking changes to the season-opening and closing venues, and expanding the season-long championship by a month.
In its continuing effort to offer competitors one of the most diverse challenges in all of motorsports, the 2009 schedule features 10 oval races, three permanent road courses and five temporary circuits and includes all but one venue that hosted the IndyCar Series in 2008.
Highlighting the 2009 IndyCar Series schedule:
The season opener will be run through the streets of St. Petersburg, Fla., on April 5.
The season-finale moves to Homestead-Miami Speedway and will be run on Oct. 11 with the speedway and series developing a championship weekend celebration, extending the IndyCar Series season a month longer than the previous two seasons.
The Grand Prix of Long Beach will be run on April 19, marking the IndyCar Series’ debut at the 35-year-old event that has hosted F1, CART and Champ Car races as its premier event.
The IndyCar Series will debut in Toronto on July 12. The Indy Toronto, which dates to 1986, will be the first of back-to-back temporary course events in Canada with Edmonton scheduled for July 26.
The Mid-Ohio Sports Car Course will shift from July to Aug. 9, allowing the series to break up what was six consecutive weeks of racing in 2008. With this date change, the Kentucky Speedway event will move one week earlier to Aug. 1.
The Raceway at Belle Isle Park and Chicagoland Speedway are exchanging weekends, with Chicagoland running on Saturday evening Aug. 29 and the temporary street event in Detroit running Sept. 6.
The Indy Japan 300 at Twin Ring Motegi in Japan is shifting to Sept. 19 after running in April since 2003.
The IndyCar Series will be a part of the Indianapolis Motor Speedway’s Centennial Celebration with the 93rd running of the Indianapolis 500-Mile Race scheduled for May 24.
The IndyCar Series will return to Kansas Speedway, The Milwaukee Mile, Texas Motor Speedway, Iowa Speedway, Richmond International Raceway, Watkins Glen International and Infineon Raceway at approximately the same time on the calendar as 2008.
“We are thrilled with the schedule we have developed for 2009,” said Terry Angstadt, the president of the commercial division for the Indy Racing League, the sanctioning body for the IndyCar Series and Firestone Indy Lights. “When unification was announced earlier this year, we talked about the opportunity of developing future schedules on a blank piece of paper, and with today’s announcement we have a solid foundation for developing a consistent, long-term schedule for the IndyCar Series.”
Next season’s schedule will feature four Saturday prime-time events, and unlike the previous two seasons the 2009 schedule affords a couple more in-season off-weekends for drivers and teams.
“Looking ahead to 2009, and with one season of unification under our belts, we know that the IndyCar Series continues to offer the most diverse schedule in all of motorsports,” said Brian Barnhart, president of the competition and operations division for the Indy Racing League. “As our schedule has evolved in the past few years, the race for the IndyCar Series championship has become one that demands the ability of both drivers and teams to master a variety of venues and the challenges each one brings with the end result being a true champion.
“We are also pleased to respond to our teams and offer a couple of more off-weekends during the core of the season.”
The Indy Racing League will announce the 2009 Firestone Indy Lights schedule in the immediate future. The complete 2009 IndyCar Series schedule:
Date Location Venue
Sunday, April 5 Streets of St. Petersburg 1.8-mile street course
Sunday, April 19 Streets of Long Beach 1.968-mile street course
Sunday, April 26 Kansas Speedway 1.5-mile oval
Sunday, May 24 Indianapolis Motor Speedway 2.5-mile oval
Sunday, May 31 The Milwaukee Mile 1.0-mile oval
Saturday, June 6* Texas Motor Speedway 1.5-mile oval
Sunday, June 21 Iowa Speedway .875-mile oval
Saturday, June 27* Richmond International Raceway .75-mile oval
Sunday, July 5 Watkins Glen International 3.4-mile road course
Sunday, July 12 Streets of Toronto 1.721-mile street course
Sunday, July 26 Edmonton City Centre Airport 1.973-mile airport course
Saturday, August 1* Kentucky Speedway 1.5-mile oval
Sunday, August 9 Mid-Ohio Sports Car Course 2.258-mile road course
Sunday, August 23 Infineon Raceway 2.245-mile road course
Saturday, August 29* Chicagoland Speedway 1.5-mile oval
Sunday, September 6 The Raceway at Belle Isle Park 2.906-mile street course
Saturday, September 19 Twin Ring Motegi 1.5-mile oval
Sunday, October 11 Homestead-Miami Speedway 1.5-mile oval
* Denotes Night race Schedule Subject to Change
The IndyCar Series is the premier open-wheel series in the United States, competing on a challenging combination of superspeedways, short ovals, scenic road courses and temporary street circuits. In 2008 the IndyCar Series will conduct 15 events in the U.S. and one each in Australia, Canada and Japan, all available worldwide through a comprehensive, long-term agreement with ESPN, including all races broadcast in High-Definition, including a motorsports first 360-degree in-car camera. A leader in motorsports technology, the IndyCar Series is the first racing series to power its Honda engines on 100 percent fuel-grade ethanol, a renewable and environmentally friendly fuel. The IndyCar Series continues to the be the fastest, most competitive and innovative racing series, attracting a diverse lineup of drivers with participants from the United States, Japan, Brazil, England, France, Spain, Australia and New Zealand. The stars of the IndyCar Series include 2005 Indianapolis 500 and IndyCar Series champion Dan Wheldon, 2004 IndyCar Series champion Tony Kanaan, two-time Indianapolis 500 champion Helio Castroneves, 2005 Bombardier Rookie of the Year Danica Patrick and 2006 Bombardier Rookie of the Year Marco Andretti. Other standouts include Scott Dixon, Buddy Rice, Graham Rahal, Will Power and Justin Wilson. For more information on the IndyCar Series, please visit www.indycar.com.
It is one of two children's centers in the nation that have this kind of research program. The other is at Emory Hospital in Atlanta.
Dr. Shean Aujla, a pulmonologist at Children's, said there have been few studies on severely asthmatic children. She said it is important because these children end up missing more school and having more visits to the emergency room because of ineffective medications. Sometimes children even die from the condition.
"Most of the studies in severe asthma and what we know about severe asthma are in adults," Dr.Aujla says.
Five to 10 percent of asthmatic children are classified as having severe asthma, Aujla said.
Beth Wood (D) 46
Les(lie) Merritt (R) 34
Wood has shown a strong lead over Merritt three polls in a row now so I don't think this is a fluke. I find this so curious. Steve Troxler and Cherie Berry are doing fine in the polls so it's not a universal problem with Republicans. Why is an incumbent in a low profile race doing so poorly? If anyone can give me a non 'Democratic talking points' answer I'd really like to hear it. One problem for Merritt is that he's getting only 62% of the Republican vote- is there some reason people in his own party don't care for him?
Walter Dalton (D) 40
Robert Pittenger (R) 36
Phillip Rhodes (L) 6
Dalton is still holding onto a small lead. As I've said before, if he can compete money wise with Pittenger spending from his personal fortune, he should be fine.
Bill Daughtridge (R) 41
Janet Cowell (D) 40
Daughtridge has shown a small lead three months in a row, and once again unusual support for a Republican from his 252 area code seems to be making a difference. He and Cherie Berry are the only Republicans leading there.
Roy Cooper (D) 50
Bob Crumley (R) 35
Secretary of State:
Elaine Marshall (D) 46
Jack Sawyer (R) 36
Cooper and Marshall should be locks.
Steve Troxler (R) 44
Ronnie Ansley (D) 38
Cherie Berry (R) 42
Mary Fant Donnan (D) 38
Troxler and Berry start out with the lead, but will be vulnerable if there is a tidal wave of new straight ticket voting Democrats.
John Odom (R) 37
Wayne Goodwin (D) 36
Mark McMains (L) 10
June Atkinson (D) 44
Richard Morgan (R) 37
Full results here.
Pat McCrory 37
Michael Munger 6
Since the primary one poll after another has shown Bev Perdue and Pat McCrory basically knotted, but Perdue has now opened up a solid lead.
Most of the movement appears to be among Democratic voters. Last month Perdue had just a 68-19 lead with them. That figure is now 76-12, and the 15 point increase in her lead among folks in her own party accounts for most of her gain. This may be attributable to her recent endorsement from former opponent Richard Moore.
Perdue is winning the black vote overwhelmingly while trailing McCrory by just seven points with white voters. Any Democrat who can keep the Republican lead among white voters under double digits is likely to win statewide in North Carolina.
Pat McCrory has lost some of the luster off of his 'change' message in recent weeks with revelations of large amounts of out of state money being spent on his behalf and news of a letter sent to lobbyists to help in raising money for his campaign. He'll need to turn it around quick to keep the race from getting away from him, particularly with Perdue's large overall fundraising advantage.
Full results here.
DAYTONA BEACH, Fla. (July 29, 2008) - A trio of Canadian drivers will be looking to win in their home country Friday when the Grand-Am Rolex Sports Car Series presented by Crown Royal Cask No. 16 visits Montreal and the Circuit Gilles Villeneuve for the Montreal 200 (SPEED, 8 p.m. ET Friday).
Mark Wilkins of Toronto, Michael Valiante of Vancouver and Marc-Antoine Camirand of Quebec will be competing in the series' premier Daytona Prototype class, while Montreal native Sylvain Tremblay, Jean-Francois Dumoulin of Trois-Rivieres and veteran Toronto driver Ron Fellows lead a group of Canadians racing in the GT division.
The only Canadian team in the Grand-Am Rolex Series, AIM Autosport, has been one of the most improved teams in the paddock in 2008. The team has raised its sights, finishing a career-best fourth at Mid-Ohio Sports Car Course, and has five top 10s, though none have come in the last two races. The team would like for that to change this weekend.
The team flexed new-found Ford muscle at the season-opening Rolex 24 At Daytona, when each of the team's drivers had the car in the lead at the end of their opening shift. The team ran with the leaders until several nighttime incidents dropped them out of contention.
Since then, AIM Autosport has been a frontrunner, finishing in the top eight in five of the following six races and ran seventh in the team standings. Wilkins won the team's first pole at Daytona in July, while in the most recent event, Brian Frisselle passed series front-runners Scott Pruett and Alex Gurney late in the race and led 15 laps, only to have his engine fail with 13 laps remaining.
"We've been looking for podium finishes at recent races, but we're looking for a win at Montreal," said Wilkins, who co-drives the No. 61 Exchange Traded Gold /Mike Direct Connect/Telux Ford Riley with Frisselle. "We led here quite a bit last year, and it was one of our best races last season. This is a race that we're really targeting to be our race.'"
This weekend, Wilkins hopes previous experience here will help him find the top step on the podium. Frisselle led six laps here last year, with the team posting a seventh-place finish.
Another Canadian looking for victory this weekend is Michael Valiante - which would be a repeat performance for SunTrust Racing. Last year, Max Angelelli teamed with Jan Magnussen and came home a winner. This year, Valiante is Angelelli's new co-driver on a new car, as the No. 10 team switched to the Dallara chassis this year. Valiante, who won a pair of poles and led in six of the opening seven races in 2008, finishing a season-best third in the Sahlen's Six Hours of The Glen.
Open-wheel star Marc-Antoine Camirand of Saint Leonard d'Aston, Quebec, co-drives the No. 09 Spirit of Daytona Porsche Coyote with Guy Cosmo. Montreal is one of the selected races the team is running in 2008. Camirand won here in 2004 in the Hankook Tire Touring Car race.
The three Canadians have joined the remainder of the Daytona Prototype field with a common goal - trying to stop the TELMEX Chip Ganassi Racing with Felix Sabates Lexus Riley of Pruett and Memo Rojas. The pair, which finished fifth here last year, won six of the opening nine races - including the Rolex 24 of Daytona (joined by Juan Pablo Montoya and Dario Franchitti) and the Sahlen's Six Hours of The Glen, where Pruett drove the final three hours in 90-degree heat. They hold a 60-point lead (295-235) over last year's champions Alex Gurney and Jon Fogarty.
Gurney and Fogarty have struggled throughout this season after winning seven of 14 events last year in the No. 99 GAINSCO/Bob Stallings Racing Pontiac Riley. They were winless through the opening seven rounds of 2008 before finally breaking through in the rain at the Mid-Ohio Sports Car Course. Since then, Gurney was passed on the final lap by Pruett in the Daytona event earlier this month, and the car's clutch failed after Gurney led the most laps at Barber Motorsports Park.
Riley-Matthews Motorsports won in Mexico City with drivers Jim Matthews and Marc Goossens. Cheever Racing had its best showing of 2007 in Montreal, when rookie Antonio Garcia led three laps en route to a fourth-place finish. Garcia has competed in eight of the nine Rolex Series races this season, and welcomes back former co-driver Christian Fittipaldi, who spent 2006 and 2007 as the team's lead driver. In addition to the Daytona Prototype run last season, Fittipaldi has competed at Circuit Gilles Villeneuve in Formula 1 and the former Champ Car World Series.
Other teams have been closing in on victory this season. Brumos Porsche posted back-to-back runner-up finishes with Toronto-born Darren Law and David Donohue; Michael Shank Racing had both of its Ford Rileys on the front row for the Rolex 24 At Daytona; Doran Racing has been running near the front with its two Dallaras; Krohn Racing is running the new Lola chassis, with its two-car lineup including Formula 1 veteran Ricardo Zonta and Nic Jonsson in the No. 76 Pontiac and Tracy Krohn teamed with Oliver Gavin in the No. 75 Pontiac; and Rum Bum Racing led the most laps at Mid-Ohio with rookies Matt Plumb and Gene Sigal.
Canadians Tremblay, Dumoulin and Fellows Lead GT Teams
Tremblay and co-driver Nick Ham look to continue their upswing at Circuit Gilles Villeneuve in the No. 70 SpeedSource Mazdaspeed/Castrol Syntec Mazda RX-8. With two poles and two victories in as many races (Brumos Porsche 250 and Porsche 250 at Barber), the duo is inching closer to GT point leaders Kelly Collins and Paul Edwards in the No. 07 Banner Racing Banner Engineering Pontiac GXP.R, with only 14 points separating the teams (292-278). The SpeedSource sister car, the Watkins Glen-winning No. 69 machine driven by Emil Assentato and Jeff Segal, looks to rebound from two straight 17th-place finishes.
After winning three races early in the season, Collins and Edwards have been off the podium in three straight events. They look for better results at Montreal, where they placed eighth last year despite running third on the final lap. The sister Banner car, the No. 06 Pontiac GXP.R that finished fifth here last year, is slated to be driven by team owner Leighton Reese and Canadian native Ron Fellows, who will also drive Dale Earnhardt Jr.'s Nationwide Series car in the Saturday race.
With one victory in 10 GT events in 2008, Porsche will be looking to return to the form that saw it win here last year and take three of the top four positions. Andy Lally, who teamed with RJ Valentine to win last year's race, returns to lead four Porsche GT3s entered by TRG, which is seeking its first race victory since last year at Montreal. Lally will co-drive with Tim George Jr. in the No. 67 entry, while Valentine teams with Bryan Sellers in the No. 68 Porsche GT3. Also entered are the No. 65 TRG/Riegel Autosport Porsche GT3 driven by Craig Stanton and Canadian Hima Maher and the No. 66 TRG Porsche GT3 driven by Ted Ballou and Spencer Pumpelly.
Dirk Werner and Bryce Miller of the No. 87 Farnbacher Loles Racing Porsche GT3 look to continue their hot streak, with two consecutive second-place finishes in the past two races. The pair also finished second in the 2007 Montreal 200. Leh Keen and Eric Lux of the No. 86 Farnbacher Loles Racing Porsche won at Mid-Ohio, and the team's third car, the No. 88 Porsche, is slated to be driven by Toronto's Dave Lacey and Steven Johnson.
The No. 57 Stevenson Motorsports Stevenson Automotive Pontiac GXP.R team of Andrew Davis and Robin Liddell hope to capture a podium finish, which narrowly eluded them in the last contest at Barber. They are sitting first in number of podium finishes in GT for the season with six, and are tied for fifth in points with 265.
Blackforest Motorsports have two cars entered for this weekend's competition with a lineup dominated by Canadians. The No. 15 Blackforest Motorsports Ford Mustang GT will be driven by Jean-Francois Dumoulin of Trois-Rivieres, Quebec, and Tom Nastasi of Stamford, Conn. The No. 50 Mustang will seat drivers David Empringham and John Farano - both of Toronto.
Practice for the Montreal 200 begins at 12:30 p.m. ET Thursday. Qualifying begins at 1:15 p.m. ET Friday, with the 200-mile race (74 laps with a two hour time limit) taking the green flag at 4:21 p.m. ET.
- This is Round 11 for the Grand-Am Rolex Sports Car Series presented by Crown Royal Cask No. 16. The combined Daytona Prototype/GT race is two hours or 200 miles (74 laps), whichever comes first.
- The green flag for the race is scheduled to fly at 4:21 p.m. ET on Friday. The race will air same day delay on SPEED, beginning at 8 p.m. ET (Leigh Diffey - Play-by-Play; Dorsey Schroeder, Calvin Fish - Analysts; Brian Till, Chris Neville - Pit Reporters).
- All cars must make a mandatory pit stop prior to the 45-minute mark in the race, and each driver must complete 30 minutes of the race in order to earn points for their respective standings.
- 2007 Montreal race winners were Max Angelelli and Jan Magnussen (Daytona Prototypes), and Andy Lally and RJ Valentine (GT).
ROLEX SERIES WEEKEND SCHEDULE (ALL TIMES EASTERN)
- Thursday: Rolex Series Practice (12:30-1:30 p.m.); Rolex Series Practice (2-3 p.m.); Rolex Series Practice (3:30-4:30 p.m.); Rolex Series Practice (5-5:30 p.m.); Rolex Series Trueman/Akin Practice (5:30-6 p.m.)
- Friday: Rolex Series Daytona Prototype Qualifying (1:15-1:30 p.m.); Rolex Series GT Qualifying (1:35-1:50 p.m.); Montreal 200 (4:21 p.m.; 200 miles/74 laps/two- hour time limit).
2008 IN REVIEW
Scott Pruett and Memo Rojas hold a 60-point advantage (295-235) in the Daytona Prototype standings after six victories and second and third-place finishes in their first nine starts. They won the Rolex 24 At Daytona, the GAINSCO Grand Prix of Miami, the Bosch Engineering 250 at VIR, the Sahlen's Six Hours of The Glen, the Brumos Porsche 250 and the Porsche 250 presented by Bradley Arant in the No. 01 TELMEX Chip Ganassi Racing with Felix Sabates Lexus Riley. In the Brumos Porsche 250, Pruett passed Gurney on the final lap to win the Brumos Porsche 250. Defending series champs Alex Gurney and Jon Fogarty won the rain-soaked EMCO Gears Classic at Mid-Ohio Sports Car Course in the No. 99 GAINSCO/Bob Stallings Racing Pontiac Riley. Marc Goossens and Jim Matthews won the Mexico City 250 in the No. 91 Bob Stallings/Riley-Matthews Motorsports Pontiac Riley, while Ryan Dalziel and Henri Zogaib earned their initial Daytona Prototype victories in the No. 2 SAMAX BMW Riley at Mazda Raceway Laguna Seca.
Consistency and nine top 10s - including three class victories this season - have No. 07 Banner Racing Pontiac GXP.R co-drivers Kelly Collins and Paul Edwards atop the GT point standings, 14 points (292-278) over their closest competitors, Rolex 24 At Daytona winners Sylvain Tremblay and Nick Ham in the No. 70 SpeedSource Mazda RX-8. Overall, Tremblay and Ham have won three GT races this season. No. 57 Stevenson Motorsports Pontiac GXP.R co-drivers Robin Liddell and Andrew Davis won two straight races this season, and No. 69 SpeedSource Mazda RX-8 drivers Jeff Segal, Emil Assentato and Nick Longhi won the Sahlen's Six Hours. Eric Lux and Leh Keen drove the No. 87 Farnbacher Loles Racing Porsche GT3 to the victory at Mid-Ohio.
NEWS & NOTES
- Hometown Heroes: Three of the Daytona Prototype drivers reside in Canada. Marc-Antoine Camirand lives in St. Leonard d'Aston in Quebec, while Mark Wilkins resides in Toronto and Michael Valiante in Vancouver. In addition, Darren Law was born in Toronto. In GT, Blackforest Motorsports will field two Mustangs for three Canadians. Jean-Francois Dumoulin of Trois-Rivieres will share the No. 5 Mustang with Tom Nastasi, while Toronto drivers David Empringham and John Farano co-drive the No. 50 entry. In addition, Dave Lacey of Toronto will share the No. 88 Farnbacher Loles Racing Porsche GT3, co-driving with former NFL tight end Steve Johnson.
- Home Turf for AIM Autosport: The No. 61 AIM Autosport Exchange Traded Gold Ford Riley is the only Daytona Prototype team based in Canada. Mark Wilkins and Brian Frisselle drive for the Toronto team.
- Double Duty: Three drivers are expected to compete in both the Montreal 200 and Saturday's NASCAR Nationwide Series race. Daytona Prototype point leader Scott Pruett will drive Chip Ganassi Racing's No. 40 Fastenal Dodge in the NASCAR race after sharing the team's No. 01 TELMEX Lexus Riley with Memo Rojas in the Montreal 200. Ron Fellows, who will drive the No. 06 Banner Racing Pontiac GXP.R on Friday, is expected to drive a Chevrolet fielded by Dale Earnhardt Jr. in Saturday's NASCAR Nationwide Series race. In addition to driving the No. 27 O'Connell Racing Porsche GT3 in the Montreal 200, Kevin O'Connell will drive the No. 09 General Environmental Chevrolet in the NASCAR race. Kevin Roush, his Rolex Series co-driver Friday, will be his spotter the following day.
- Rolex Grads in NASCAR Race: La Salle, Quebec driver Patrick Carpentier, who will drive in the NASCAR race, has competed in 10 races in the Daytona Prototypes, with his best finish second in the 2007 Rolex 24 At Daytona. Sports car veteran Max Papis, who shared the 2004 Daytona Prototype championship with Pruett and is a five-time Rolex Series winner, will drive the No. 64 Atreus Homes Chevrolet. Brad Coleman also began his career in the Rolex Series as part of Team 16 in the 2005 Rolex 24 At Daytona.
- Substitute Roles: Oliver Gavin will join Krohn Racing this weekend, pairing with car owner Tracy Krohn in the No. 75 Pontiac Lola. He has two victories and two runner-up finishes with the team. He will substitute for Eric van de Poele, who will be in his native Belgium this weekend, seeking his fifth victory in the 24 Hours of Spa at Spa Francorchamps. Due to a recent knee injury, Ross Smith will be replaced by Peter Ludwig, who races fulltime in the KONI Challenge Series, to co-drive with Doug Peterson in the No. 30 Racers Edge Motorsports Mazda RX-8.
- Hall Pass: Originally, Ricky Taylor was expected to miss Friday's race due to a conflict with classes at the University of Central Florida, where the 18-year-old is a freshman. However, he was cleared by the school to race the No. 47 Brach's/CDOC Doran Racing Ford Dallara for the fourth straight race with Burt Frisselle. His best finish with the team is fifth in the most recent race at Barber Motorsports Park, matching his career best of fifth in the 2008 Rolex 24 At Daytona, where he co-drove his father Wayne Taylor's No. 10 SunTrust Pontiac Riley.
- Hollywood Style: Actor and GT Series competitor Patrick Dempsey is slated to co-drive the No. 40 Hyper Sport Mazda RX-8 with Joe Foster. Dempsey has six starts this season with a best finish of 11th at Daytona.
ROLEX SERIES POINT STANDINGS
- Daytona Prototype: 1. (tie) Scott Pruett, Memo Rojas, (295); 3. Alex Gurney, Jon Fogarty (235); 5. (tie) Marc Goossens, Jim Matthews (224); 7. (tie) Mark Patterson, Oswaldo Negri (217); 9. (tie) Darren Law, David Donohue (210).
- GT: 1. (tie) Kelly Collins, Paul Edwards (292); 3. (tie) Sylvain Tremblay, Nick Ham (278); 5. (tie) Andrew Davis, Robin Liddell (265); 7. Tim George Jr. (240); 8. Ted Ballou (229); 9. (tie) Bryce Miller, Spencer Pumpelly (225).
- MESCO Building for the Future Rookie of the Year: 1. Tim George Jr. (240); 2. Ted Ballou (229); 3. Ricardo Zonta (206); 4. Jeff Segal (205); 5. Lawson Aschenbach (203).
- Pruett, Ganassi Continue Winning Record: Scott Pruett and Chip Ganassi continue to set records for overall wins in the Rolex Series. Pruett notched his 20th overall win in the Porsche 250 presented by Bradley Arant at Barber Motorsports Park, now seven more than second-place James Weaver. In turn, Ganassi earned his 21st win - all in Daytona Prototypes - 10 more than the SunTrust Racing team. Pruett has also finished in the top 10 in 28 consecutive Rolex Series Daytona Prototype races.
- Pontiac Owns Class Win Record: With seven class victories this season, Pontiac has passed Porsche for all-time class wins. Pontiac owns 51 class wins, while Porsche, which won for the first time in 2008 in the GT class at Mid-Ohio, has 50.
SELECTED PRE-RACE DRIVER QUOTES
Paul Edwards (No. 07 Banner Racing Pontiac GXP.R): "We were running strong last year until a big pile up in the Casino turn and I spun. We were able to get a good toe down the straights and the GXP.R is always good in transitions and through the corners. We were able to hang with the front cars. We are still at a deficit to the other cars so we will need a trouble free race on the track, pits and in the inspection line. Montreal is a great track; I would love to be on the podium for this race. It supposed to be nice and cool, (so) we can turn the A/C off and get a couple extra horsepower."
Marc-Antoine Camirand (No. 09 Spirit of Daytona Racing Porsche Coyote): "It's always great to race in Canada, but especially at Montreal, because it's only an hour from my home. I love the circuit - I've won here a few times in other cars - and the crowd will be awesome. The people there are real racing fans.
"A lot of my friends and family members will be there, so it will be good to go to Montreal and race in front of that crowd of people as well. I've raced there before, but obviously at these levels the competition is pretty tough, so I'm sure the other drivers are going to figure out the track pretty quickly as well."
Michael Valiante (No. 10 SunTrust Racing Pontiac Dallara): "Any time I get to race in my home country, it's a big honor to be representing Canada in this series. Racing in Montreal is a little bit different from being in my home town in Vancouver, but I'm really looking forward to it. It's a great facility and I really enjoy Montreal."
Jean-Francois Dumoulin (No. 15 Blackforest Motorsports Ford Mustang GT): "Last year we finished fourth - and we almost got third, actually. The Mustang passed me on that last turn. There was an incident in the last corner. Obviously we all want to try and win races, which is why we're all here. I think we have a good chance with the Mustang at Montreal, and since it's my home track, I'll be pretty excited. The team's been working really hard. We had some motor issues this year, but I think everything should be sorted out for Montreal. I know that track and my co-driver and I are really good at that track. It's a warm-up for my real race - Trois-Rivieres.
"It's always fun to race at home; you know a lot people. All my friends will be there. I don't really get nervous when they are all there. Actually, I think the extra pressure helps me out."
Christian Fittipaldi (No. 16 Cheever Racing Pontiac Coyote): "I am happy to be back with Cheever Racing and the Crown Royal Cask No. 16 Race Team, and especially look forward to driving again with Antonio (Garcia). We get along very well and I admire his skill as a driver. This combination has great potential."
Mark Wilkins (No. 61 AIM Autosport Ford Riley): "I've raced pretty much everything here: Formula Renault, Formula Ford 1600 and Formula Mazda, so I've got quite a bit of experience here. It's different from the tracks we usually race on, so I'm looking forward to it. Running the open-wheel cars helped me in my move to Daytona Prototypes here last year, because the lines are pretty similar. Getting used to the extra weight of the Daytona Prototype was the big difference, but the experience in open-wheel cars really helped me get up to speed last year."
Sylvain Tremblay (No. 70 SpeedSource Mazda RX-8): "It's my hometown; my home track. We had a great run there last year, just with some problems. I really enjoy the track and the French-Canadian culture. It's neat to bring my team and my crew to where I grew up, so they can see a lot of the things I talk about. That's always fun.
"We focused improving a couple of key areas for our run at Montreal. We made some changes to improve our car dramatically and that should make a big difference there. Every year, it's a case where there will be someone I haven't seen in 10 years - and it's always fun to go. It's a very busy time for us, with extra family and that sort of thing, but I enjoy all of it!"
Alex Gurney (No. 99 GAINSCO/Bob Stallings Racing Pontiac Riley): "Montreal is a great track and one that I've always loved. Having watched the F1 races over the years, it's always a special kind of feeling racing on the same track as they do. Now, with the NASCAR Nationwide Series there as well, our Montreal weekend is a very big happening. Last year, it looked like we were headed for a win but a faulty wheel gun put a stop to that. We fell to 10th after our mishap and I had a great time trying to make it back toward the front. I made it up to third and was very happy to get by Scott Pruett in the last few laps for the last podium spot. There are some very long straights at Montreal, which hasn't been our strong suit this year, but everyone on the team and everyone at Pontiac have been doing everything possible to give us the best possible package. With the championship looking more and more difficult, we very much want to win this race, especially since we think we gave one up at Barber."