Biotech Values

[DewDiligence]

>If [Satraplatin] was approved but failed to show OS, FDA could always blame the cross-over, which was similar to Nexavar's RCC…<

The Nexavar case strengthens your argument to some degree; however, the gap in time between PFS and final-OS reporting for Nexavar was not as compressed as it will be for Satraplatin. It is the compressed time gap between PFS and final-OS reporting that makes Satraplatin an unusual case, IMO.

>…and the 12-month minimum follow-up HR of 0.81 would be more than sufficient to convince the MD's and sway the statisticians.<

To be persuasive, GPCB will need to show that the 12-month-minimum subgroup was not cherry-picked from a bunch of other subgroups they evaluated. Did they also look at subgroups with minimum follow-up of 8, 10, 14, 16, and 18 months? You get the idea.

>The need to await OS data is correlated with the question of whether PFS data is compelling… I think scenario 1 [in message #49956] is unnecessary.<

This is probably the main difference between your analysis and mine. I think some panel members may want to separate the interest/non-interest in waiting for the final OS data from the robustness/non-robustness of the PFS data, especially if the FDA encourages the panel members to approach the problem in this manner.

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

I know very little about SPPI’s non-Satraplatin programs, so I’ve focused on GPCB rather than SPPI. I think you and I agree that the briefing docs were not really negative for the sponsors and the market overacted. However, GPCB’s valuation had already risen too far, IMO, and it was thus set up for a big fall from even a modicum of newly raised doubt.