Biotech Values

[p3analyze]

Yes I assigned senario a probability of 0 for the following reasons:

1. As stated, FDA always asks them to vote 2 questions- whether it demonstrated substantial evidence of efficacy (unless Maha insists that the question be reworded as "establishing efficacy"), and whether it was shown safe. I don't think they will deviate from that format and insert a question of whether should wait till year end of OS data.

2. The need to await OS data is correlated with the quesiton of whether PFS data is compelling. If not, then obvoiusly they must wait for the OS. So the probability is contained in 2b).

3. Doesn't mean I think the OS data is unimportant, using past history as a guidance, for accelerated approval, so long as one can show OS data trended positive, and PFS the surrogate endpoint is robust, plus evidence of patient benefit (pain data), then AA should be granted. I think PFS interrater discrepance and pain definition were red herring FDA threw out to make the AC look less like a formality.

4. FDA doesn't want to wait for OS:
a) FDA statistical review is tame regarding OS contrasted to that for Gemzar ovarian, for which the statisitician wrote in length how the argument of how low the probability is to show OS significance. No such argument was made - and I think the interim ITT hazard ratio of 0.9, the taxane pretreated subset HR of 0.88, and the 12-month minimum followup HR of 0.81 would be more than sufficient to convince the MD's and sway the statisticians.

b) If it was approved but failed to show OS, FDA could always blame the cross-over, which was similar to Nexavar's RCC, and at the independent DMC's recommendation which spoke for oncology community's support for the cross-over decision. FDA medical officers were able to fend off scathing objections from Mark Rothman, the FDA statistical lead who claimed that even if cross-over were to blame, then it means Panitumumab used in fourth-line is as good as third-line and should not be approved for third-line.

c) If FDA accepted the package and granted priority review, then it must not worry about OS.

For these reasons, I think senario 1 is unnecessary.

Now, what do you think the price for SPPI will be at if AC approves or rejects?