28 weeks boceprevir, a long shot, but I am not that concerned, although it is in Schering's interest to maintain 48 week treatment. Could very well be that the FDA required 28 week treatment and it will juxtapose against 48 week treatment given the present data out of boceprevir.
I am more surprised that they are pursuing prior partial responders and relapsers, although I understand they are not pursuing prior non-responders. They are devoting less than 400 patients to this arm of the trial, hardly a strong Phase 3 trial on this second line indication (calculated by the press release indicating 1400 patients, with over 1000 in the treatment naive indication).
Which may be implicitly positive for Prove 3 registration, as Prove 3 had 440 patients enrolled (larger than SGP's Phase 3 trial) and it was at least as comprehensive as I imagine SGP's prior failure Phase 3 will be. Prove 3's 2B trial was every bit and probably more of a Phase 3 than what SGP is running for prior failure patients. It would frankly be disconcerting to see boceprevir get a label extension based upon a less than 400 person clinical trial (after what can only said to be an utter efficacy failure in Phase 2 (albeit they learned things from it) when Prove 3 is at least as and probably more comprehensive and probably greater powered than what SGP is running in Phase 3, and then require VRTX to run a Phase 3, which of course would need to be even more comprehensive than Prove 3, essentially making VRTX run 2 phase 3s, and SGP to run only one phase 3, at a phase 3 that is both smaller and less comprehensive than VRTX's original 2B trial, and this following a very disappointing phase 2 trial for boceprevir in this indication. This would hardly be a level playing field, and clearly SGP would be given superior treatment by the FDA than what VRTX is receiving should that be the case, and should Prove 3 results be consistent with the 107 results. It would be outrageous, and not in any patients best interest, not even arguably so of the Prove 3 results are consistent with 107.
Not like the FDA really cares, but it would be the reality and would further demonstrate a broken regulatory body. But that don't make us money, just griping points.
In regard to the latest presentations, the May 21 presentation is a waste of time, don't bother. Simple talking points and then all questions in the green room.
The May 13 presentation is worthwhile however. The early Prove 3 registration question was indeed asked and answered, and more comprehensively by Michael Partridge than he would the following day at the May 14 presentation. Basically, like Ian Smith, he would not rule out early registration. He beat around the question, and basically said that Phase 3 is the next logical step, to get it going by Q3 and that they had not yet had discussions with the FDA about an early registration strategy, and basically he really could not talk about it or speculate about it. Basically doing so would be "difficult" and he just could not talk or speculate about any other registration strategy other than currently getting the Phase 3 going. So just be quiet about it. Not even a "wink-wink" as they would be too loud. Clearly, it is a very sensitive issue, and VRTX is going to pursue it, but one thing at a time, and they did not want to upset the very sensitive FDA in an shape, manner or form until such time as the tiem was right to discuss it (which I would presume would be sometime in Q3 or Q4 of this year after the final Prove 3 numbers are in).
So we will need to wait but they have clearly not ruled out an early registration based on Prove 3, they are just being very careful and extremely conservative in regard. Look to getting Phase 3 going early and then we will go from there. It seems clear, however, that VRTX's phase 3 will just be a rehash of Prove 3, but perhaps larger (again, implicitly, if SGP's Phase 3 is sufficient for a registration strategy in the second line, then why should VRTX have to run a greater burden since Prove 3 is already larger and more comprehensive, and at least as well controlled as SGP's trial was - and heck, there is more safety data on telaprevir than on boceprevir).
Yes, speaking logic and reason, but those are the plain facts. We will have to examine how the FDA handles this, and it will be very interesting and perhaps very disconcerting. I'll hope that it will prove more interesting than disconcerting.
Michael also commented on boceprevir data, and what he noted as most striking was boceprevir's non-responders (I think referring to prior failures of whatever category) where boceprevir came up very flat even if they did maybe learn something. Also mentioned BID dosing.
But this was the most interesting portions of the presentation and my analysis of it. Michael Partridge did not lay out the disconcerting parts, or the comparison with boceprevir heading to phase 3 on the second line indication or such, but it just seems very self-evident to me and thus my comments above.
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