Biotech Values

[BTH]

I think the rida situation speaks more to the FDA's posture on the SPAs it grants, and what it wants to do with the PFS endpoint in general.

If you have the entire Ridaforolimus group having a 3 week progression free benefit (on the median), how would, say, a 20 week benefit in a majority of patients on the leiomyosarcoma subset versus a 3 week benefit in the vast majority (or no benefit at all) of osteosarcoma subset be looked at by ODAC or the FDA?

What I am getting at is, I believe there are going to be dramatic differences in the subsets (a few of the STS showing dramatic PFS results - whereas Bone sarcoma, IMO, likely to show little, if any, difference). Has there ever been a situation whereby a drug has been approved in such a heterogeneous indication, in which some subsets show great benefit, and others do not? How would ODAC and the FDA approve, or not approve such an indication? Drug labels? Completely decline the drug or make them do another Phase 3 or 4 trial?

Personally, I believe the subset numbers and OS numbers (in those who showed the most benefit) are going to show a benefit worthy of approval, but, as someone just pointed out (and after re-reading it again), that Board of Director Letter about Berger was disturbing (to say the least), and the guy is still one of the biggest jerks in all of biotech; it's it's likely THEE number one reason the larger investors are questioning Ridaforolimus right now.

Thanks