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Post by liane on Jan 11, 2014 11:07:44 GMT -5
Mnkdmillionaire, You just made my point. Adcoms and FDA are both unpredictable. Add the two together... Chris, When I defended Morningstar's valuation of $6B (~$20/sh) as in the ballpark, I got attacked for being way too pessimistic. In what way have I used "non-correlated, unstated sample size to justify a point"? I am a mathematician. Of course every case is different. If you wish to challenge my inferences, at least read the source from which I quoted. I may be completely off base re my concerns re the adcom. I hope I am. But the knee-jerk, ill-informed, ad hominem I am getting is disappointing to say the least. I expected better when I joined this board. I won't be posting any more. Good luck to all. alcc, I, for one, don't have a problem with a healthy dose of skepticism at this point. My interpretation of your posts is that you are looking at all the angles. I do not believe you are short (and it would not matter if you were), but I can see how some on the board might conclude that. You present intelligent posts, so that is not bashing. I would remind everyone to stick to the content. Thanks!
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Post by alcc on Jan 11, 2014 13:47:29 GMT -5
In hindsight, the company is at fault for not preparing the market to expect an adcom. After all, Exubera had one. Worse, Al Mann said (in interview or earnings conf call, or both) he did not expect the FDA to call for an adcom. As we all know, the mkt hates surprises. The right response (mea culpa) is to take a deep breadth and see adcom as an expected step (hurdle?) to approval. The late date means possible delays. But that is the only real news yesterday.
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Post by babaoriley on Jan 11, 2014 17:00:03 GMT -5
I can see the FDA asking for further studies, but only to extend the label, they've done enough, and it either will or will not be approved based on the current status of testing, trials, etc. If it's not, I think we're essentially toast. Again, I can see an approval with further study for whatever reason the FDA might come up with.
I agree with Liane re it was the FDA and only the FDA that wanted the AdCom. As to a delay in the PDUFA, sure, I could see it slipping into May, but no further. AdCom happens all the time, in fact, more often with, than without, I think.
The thing that threw much of the market for a loop, not to mention us, was the fact that it hadn't been required the last two times, well, the last two times didn't work out so well, so perhaps the AdCom will be the charm!
As for the fishiness in the share action the last two days as MnkdMillionaire references, well, I didn't find yesterday's action fishy, but the two prior days, you betcha! But good fishy, in contrast to bad fishy! I know why we fell yesterday, not sure why we rose so dramatically previously, but I was hoping for....
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