Wednesday, April 25, 2007 6:25:07 AM
The recent strongly worded press release was likely a factor, with Dr. Stoll using phrases like "there is CLEAR evidence", and "the FACT that the histo changes occur postmortem". In Dr. Stoll's mind there appears to be no ifs or buts about it. Coming from him that carries considerable weight, since he's always been a straight shooter and low key.
Another factor may be the realization that the dosing decision is likely going to come out of the blue, and fairly soon, and possibly independent of any 60 day clock. As Dr. Stoll indicated in his email, the requested face to face meeting with the FDA and it's theoretical 60 clock is for discussions on the Phase 2b ADHD IND, not for the dosing decision. This is a key piece of info, and means that the FDA could realistically issue their dosing decision at ANY time. There was a lot of data submitted, but all they really need to do is zero in on the target organ and electron microscope pictures, which could be accomplished quickly. Dr. Stoll called the data compelling. With unambiguous data, the FDA's decision could be cut and dried. As an investor therefore, one has to be in the stock or risk missing the boat completely.
Another factor I find heartening are Dr. Stoll's comments that the FDA has been reasonable, that their interactions have been constructive, etc. That's a key element, and having the FDA consultants on board from the beginning has undoubtedly helped in that regard.
Fwiw, I see the mid $3s over the next couple weeks.
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