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.
Yes I know. My point is that you were saying it is about P2s and P3s, and I said no it is not. And you agreed with me that it is not but then said to deal with it.
Also, I don't have moose breath. I believe you are smelling your own breath after accidentally mating with a moose.
Well, if we are to talk about the law,
1) Orphan drug and fast track designation has nothing to do with data in a trial. The FDA does not have access to this data and it is they who determine fast track and orphan drug designation.
2) Insider trades must be declared well in advance of the trades taking place (months or years), usually with a purchase or sales plan submitted to the SEC.
See CMRX. The only reason their trial failed, wiping out 2B of market cap, is because 36% of doctors did not follow the SMMP (safety monitoring and management plan) procedure, even with a DSMB there to advise the company. Incompetent management failed ensuring a very simple step of preventing the drug from being taken during bouts of diarrhea and destroyed the stock price.