Possibly, Pfizer does not want more regulatory scrutiny than it already has. It may be a bureaucratic decision due to the heavy web of Pfizer management rather than one based on cost-benefit.
Maybe the PFS is pretty much the same as placebo but the ORR is much different? Maybe sometimes the cancer popped in but was then mostly kept at bay by a booster shot later on. So, maybe it is just that the effectiveness of the booster shot (except at the very beginning) is not good. However, how does this explain the timing of the 70 event data point?
Of course we cannot control that, but we should try to understand the topic to get a better idea of what might happen and trade accordingly.
Plenty of drugs do not get approval without an adcom. Where is your 98% figure from?
I mean it is possible, yes. What are the chances.... unknowable. I guess we will find out more in the next few weeks.
Given the Visium situation, I would not put it past someone in the CRO to intentionally corrupt the data. The Visium situation is the tip of the iceberg, imo.
If this was an issue with the CRO making a mistake, I think it's highly improbable they just switched placebo and drug, but anything could happen.
If they made other coding errors, it may not be the fault of the company, but the company will still bear the fruit of those errors.
I agree with others. No overreaction if it is as bad as the IDMC says it is. Then again, the IMDC couldn't even decide whether it should call itself the DMC or the IDMC. In fact if the data is actually bad and you remove any probability of a mistake this should probably be trading much lower.
Maybe I slightly misread what you were saying. Still, the point stands... I don't think this is about an FDA read on the data as much as just bureaucracy.
In any case I am just saying that this is probably an overreaction based on someone at the FDA just not finishing an analysis, but I need to do more research.