"Okay, the above is about VRTX, but is my latest analysis based upon 4 presentations in the last 2 weeks by VRTX, the trial results, and the Schering Plough boceprevir news today"
Basically, Schering Plough is running a Phase 3 for prior treatment failure patients that is smaller than the Phase 2b Prove 3 trial that VRTX ran. It would be utterly incredulous to allow Schering to register for prior treatment failures (Scheirng is apparently excluding prior non-responders and only allowing the other categories of prior failure patients in the trial) on a study that is smaller than Prove 3, with a smaller safety database than telaprevir presently has, and then require VRTX to essentially and practically rehash Prove 3 in order to register, but this time with a bigger study!
Because the Phase 3 protocol that VRTX is submitting to the FDA is nearly identical to that used in the Prove 3 Phase 2b trial, and that trial was very well controlled, had 440 patients in it (compared to Schering's which will have less than 400) and has a safety base of well over 1000 patients, with more safety data being gathered by the on-going Phase 3 in the treatment naive population.
It does not take a rocket science to figure out favorite treatment if VRTX is forced to run a re-hashed, but now larger, Phase 3 before the FDA will allow registration, assuming the Prove 3 results are consistent with the 107 data release. It also does not take a rocket scientist to figure that there is no patient benefit in this very dire need indication, as no further safety data will be obtained, efficacy is already known (more so than will come out of boceprevir's Phase 3 in this indication) and is primarily process over substance.
But it is the FDA. So what I can conclude, assuming Prove 3 data is consistent with 107, is that a rational regulator, who treats all its applications equally, and offers no favoritism to any, would allow VRTX to register under the Prove 3 data early. It is clear as day. Wehther or not the FDA will indeed be this indifferent, hands off, fair, and rational regulator, looking out only after the patients best interests, now that is the catch.
I would imagine that such discussions with the FDA and VRTX will not take place until Q3 or Q4 of this year, after the final Prove 3 data is finalized. It with either be very interesting, or very disconcerting, come Q1 or Q2 of 2009. I don't think we will have to wait any longer than that, and perhaps earlier.
Any comments appreciated to this analysis. I do not see a whole lot of room for grey here however. The facts are what they are, and SGP is doing what it is doing in the prior failure treatment indication. I don't see an error in this analysis. But perhaps someone can point me to an error in my way of thinking on this one.
If your as old as me you remember the VHS vs Beta wars and of course Apple vs Microsoft. I am just pointing out that the best doesn't always win out. Telaprevir is better than Boce, we all know that but SGP knows that too. They also know if they can get into PIII quickly and fool the FDA into approval then they will have cut VRTX's first to market advantage considerably. And SGP already has the sales force and marketing in the doctors office with thier SOC treament. And Boce is a better tretment than SOC alone. I believe this will add up to sales for SGP despite Telaprevir being better. I hope this is a wake up call to VRTX. They have the advantage, use it!! At least discuss an early filing with the FDA on SOC failure patients. Whats the worst the FDA is going to say.... finish the PIII, well they would do that anyway.
I read your post with interest and much agreement. After doing a little research, I'm giggling, I found some interesting information to verify my own personal feelings that the most value from boce right now is the effect the bad information is having on Vertex stock!
Roche has articles out there about SGP and the way they conduct their trials that I found very interesting. As the two big kids on the block, Roche and SGP spend a lot of time back stabbing and trashing each other, but it is clear that SGP, in Roche's mind, dabbled in skewing numbers in their trials of boce.
With the market for Roche being $80 million in the first quarter of this year....it is no wonder there is a lack of transparancy.
SGP was popped by the FDA about three years ago for "cherry-picking" their patients in trials....why would they do any different now? Call me bitter, but like the poster you have listed, I find it appalling that I am still waiting for medication....and that we do not have crystal-clear direction from the FDA.
Pisses me off that my good health and long life is in the hands of what has been portrayed as a "brittle, flighty, unresponsive and irrational" government agency. To put it mildly.
Thanks and keep up the good work, times like last week make it pretty frustrating to be here.