"Depending on the CRL" is exactly correct. Given no further details by Nasrat gives us no idea. By itself, puzzling as the data were so good, and done with FDA advice. So that is the big question, and elusive in the PR.
I'm an ELTP "Long" so to speak, but not in love with a stock to the point where I pledge blind devotion. And not one in at .10 or less. So, WTF was behind the CRL? I was slightly suspicious when Nasrat said the board thought 90% for an adocm. Interpreted no ADCOM as good (esp. w/priority designation), but a nagging feeling that the decision was something must have been more than questionable to the FDA. Hopefully labeling over anything else, but who knows--but something IMO we should have been told. Secrecy as a strategy is good, until it acts against the companies credibility with their shareholders (not traders--companies owe traders nothing). Then the trust underlying the shares erodes, as does the confidence in management.
It maybe the news took Nasrat for a surprise. I hope the Holiday Inn Express has only two floors and he acrophobic. IMO, this may not be over, and he is competent w/good staff...or maybe he's slimy like half the rest of them; who the hell knows at this point.
Well, it's possible that more transparency, even in the PR could have potentially eased the coming sell-off. As Laser's pointed out, this should have been a "slam dunk"...in at least of two of the areas. If this is minor, there is going to be a huge buying opportunity coming, if major, Nasrat has some explaining (as if that would do us good). The science is sound, the results perfect, last done under the FDA...so what is the underlying issue? Why no adcom given? To hold, buy "cheap" shares, or dump--that is the big question. Nasrat has some explaining to do.
If he can't get it by the FDA on a reasonable second try, he might as well hit the penny rags and pump the thing for a less painful exit. He has a lot more he needs to say to long term holders, who have held, believed, and watched other opportunities go by waiting on his words. I hold no other board poster(s) in contempt as they were trying to read the same hieroglyphics, but NH yeah, he owes us more than a CC with some pre-arranged analysts.
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