Spar, you got any POZN. Take a look at one of the presentations if you've never had the chance. Pretty exciting company, and FDA decision on Trexima expected Aug/01.
Here's a pretty good post off the yahoo board.
I believe Trexima is going to get approved. I even think I know what the safety issue was. I would not state 80% chance of approval...that was one analyst (Citibank) that put a probability percentage on it. Read the other articles (forecasting approval) and do your own reasoning (dd) ... the probability is much higher than 80%. I've analyzed the heck out of this stock, drawn my conclusions...I'm convinced the FDA will approve Trexima.
Also...Trexima sales will garner big money for Pozen. (which is why it should double on approval) I believe it will double...based not only on the projections of Trexima revenue..but the added validation factor re: Pozen's drug combination technology and what that means for the PN-400 arthritis (huge market) drug (backed by Astra Zeneca) entering Phase III trials in the 3rd quarter.
Don't listen to the shorts when they talk about Immitrex going off patent and therefore migraine patients will just take 2 separate pills, generic immitrex and alleve. (naproxen) What follows comes from one of my many conversations with Fran Barsky:
Trexima is 85 milligrams of summatriptan (Immitrex) with 500 mg of naproxen. Trexima also incorporates Glaxo's RT (rapid release technology) technology..which is in the status of "patent pending".
The RT technology significantly improves absorption and disintegration of the drug. The fact that it is "patent pending" right now means that generic versions of immitrex will not be able to copy this rapid release technology. (per Fran Barsky)
Also, Fran said that Immitrex dosages consist of 25, 50, or 100 milligrams. These are the only dosages that generic versions (once Immitrex goes off patent) can replicate. Note that Pozen's Trexima is 85 mg of Immitrex, combined with 500 mg of naproxen. Pozen believes that it is this dose (85 as opposed to 50 or 100) that is most effective, when combined with the 500 mg of naproxen and incorporated with the rapid release technology.
The response from the medical community has been positive...doctors will prescribe ONE proven PILL of Trexima with the RT Technology...as opposed to "experimenting" (read lawsuits) with lower or higher dosages(remember...when immitrex goes off patent in 2009, manufacturers of generic immitrex will not be allowed to produce 85 mg pills, which is the dosage used in Trexima) of generic immitrex and a SECOND naproxen PILL. Patients will be more likely to take one pill as opposed to two. (I know, sounds circumspect but that's the reality...doctors know that patients are more likely to follow a prescription that contains one pill as opposed to two)
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