Replies to post #13710 on Biotech Values

[io_io]

DNDN:

"If the interim looks of 9902b look like a dupe then why not let the BLA be approved without 9902b being completed"

Well let's think about it .....just from a logistics point-of-view, as opposed to the regulatory point-of-view.

First, seeing as 9902b is not fully enrolled, and even if it was almost there, I don't think DNDN wants to close it yet, when will there be an interim look ? Hardly before the big q4 decision ? Nope.

Second - well the trial is long-standing, and some kind of survival statistics should be avilable, if they were to look for them. Usually stopping a trial in the case of efficacy is that the placebo patients can go on the drug. In this case, for most it would be too late, because they would be symptomatic. But are there 100 +/- patients say 20-24 monthsout by now, the kind of number needed to see near-significant efficacy, by the time of the q4 FDA meeting ? I doubt it.

Third - let's say that 9902b proceeds, either as planned or modified for all Gleason's, and it gets enrolled, and the TTP check is either mid-06 or end-06. Might they have good enough survival numbers then ? Very possibly yes. But obviously we would prefer that they file on 9901 + 9902a.