Replies to post #114706 on Biotech Values

[zipjet]

I think it is a mistake to extrapolate the FDA's resistance to accelerated approval with marginal (or even respectable) efficacy to their likely reaction to any display of spectacular efficacy.

Exactly.

Or what about a similar trial in CRPC mets with a pain endpoint.

IF, as the investigators have said the pain suddenly stops "like turning off a light switch" - it should be apparent very quickly. One of the patients said his pain stopped after 3 days on XL184.

ij

[DewDiligence]

I think it is a mistake to extrapolate the FDA's resistance to accelerated approval with marginal (or even respectable) efficacy to their likely reaction to any display of spectacular efficacy.

Well, some investors thought Roche/IMGN’s T-DM1 data were spectacular.