RE: RE: Why not just sell it all !I think Macbeth makes some good points. The action letter to come out on or before August 3 is not going to approve the drug. I mean obviously.
And I appreciate the discussion frankly since I myself am going to have to make a decision here and would like to hear more than blind hope.
When the action letter comes out either we will hear that the meeting has been rescheduled (in which case phew, minor delay) or we are going to hear that the application has been rejected (major delay).
On the bright side we haven’t been rejected yet. Obviously if there are problems the FDA could have done just that but it didn’t. So there is hope. But obviously also they are still thinking that is what they might do because otherwise they would have rescheduled meeting. So there is real cause for concern here. The jury is out and we have no idea what they might find.
So I read it this way. Most times the decision is clear cut. The application is either deficient enough that it is likely not redeemable and needs to be redone – so they just reject it OR it is deficient in some respect or there are some questions but they think that it is probably redeemable and so they reschedule the meeting to allow for more time.
So sounds to me like we are somewhere in between and probably that is rare. Now, I am guessing (but don’t really know) that this is rare because they don’t schedule the committee meeting in the fist place unless things are looking pretty good i.e. so that if stuff is deficient it is usually just stuff that needs some tweaking and hence just need more time to do so. That suggests to me that the unresolved issues are something new and also material.
As for Professional's comments that his investment is data driven, the problem with that is that it is not just data issues that leads to rejection. You can have a great drug but you just don't get it past the finish line. I would almost agree with you in the sense that even if we are forced to resubmit it is still only a matter of time before we get approval BUT we might well run out of money before then. That is how a lot of these companies fail.