and the more I read and think about it ...it probably doesn't matter... their (Merck's)studies are probably good enough to get their ANDA approved but VRTX's drug is and always will be better.
thanks for the thoughtful reply
"Was VRTX too conservative in waiting for all the T's to crossed and i's dotted?"
Yes, but with good reason. This is the first NDA for VRTX, and I don't imagine preparing such a document is trivial.
Merck has been through this quite a few times already.
Let's face the fact: of course the first drug gets approved will enjoy some benefits. But Merck just filed NDA maybe 2-3 weeks earlier, that does not mean they will get Boceprivir approved (2-3 weeks) earlier. I doubt FDA will NOT compare the pros and cons of the two drugs and make their decision.
In short, I still believe Telaprivir will get approved before Boceprivir based on efficacy and safety profile. However, Vertex should ponder why Merck caught up so fast as Telaprevir used to be at least 1-2 yrs ahead of Boceprevir. Now almost neck to neck... What a shame.
This is a perfect example of politics over medecine.
Telaprevir has been around for 11 years now. It should have been available around 2008. The FDA gave them the run around until Boceprevir could catch up. Boceprevir was four years behind. It's all about money and in the meantime people wait and die.
"However, Vertex should ponder why Merck caught up so fast as Telaprevir used to be at least 1-2 yrs ahead of Boceprevir."
As a long term holder of this stock (since 90's) I can tell you why. The founder of VRTX, Joshua Boger, the so called molecule man,(BTW a book was written about him) believed that he should share with the scientific community all the details of his research and the methodology of developing protease inhibitors (remember he was a pionier in co-developing Lexiva)as well as other drugs to the research community because he felt a competitive environment will make his company to work better and harder and, therefore, be able to develop more effective drugs. Well all the competitor companies used his methodology to catch up with him. In fact for a long time Boger was not a favorite on the VRTX message board and many of us used to call him Dr. Bogus.
Was he right with his approach? I personally think he was a great scientist and contributed a hell of a lot to the biotech world and I think some day he should be recognized for his contributions. As to whether his decisions were the best for shareholders, I don't think they were.
I am not unhappy about my vrtx investment, but for my long term investments in VRTX (and I bought many shares in the $11 area), I still would have been better off financially in other investments.
>>"A Vertex spokesman said, "We expect to hear from the FDA this month regarding our request for priority review."
did Merck request priority review?! <<
Almost certainly, but it doesn't matter much which drug gets filed first or even approved first. What really matters in the marketplace is which HepC drug works the best (i.e., best efficacy and safety profile). Thus far, all of the clinical data point to that drug being Telaprevir.