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Biotech / Medical : ACADIA Pharmaceuticals Inc (ACAD)
ACAD 25.04+0.9%Nov 28 9:30 AM EST
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To: mopgcw who wrote (377)1/12/2007 11:06:14 AM
From: NeuroInvestment  Read Replies (2) of 588
 
Well--those considerations all involve a far more sophisticated handle on the chemistry than I have. I saw Acadia yesterday--they are circumspect about the agranulocytosis issue, basically taking the tack that they'll have to acquire data on a thousand or two thousand patients before they can start making more definitive statements about the agranulocytosis issue. I think there are two separate questions here:

1) Does the incidence of one case of mild leukopenia show some causal link? No, and there are the hypotheses mentioned in the Lehman note that would argue against it.

2) How will they prove the negative in the eyes of the FDA, in order to obtain labeling free of a Clozapine-like warning? That's the tougher hurdle. The fact that one case was seen makes it that much more difficult IMHO. While Acadia has none of the baggage with the FDA Cephalon has, one purported case of Stevens-Johnson syndrome (which now appears to not even have been SJS) led to the FDA stonewalling Sparlon (the enantiomer of Provigil)--and Cephalon ended up terminating the project.

Lehman may well be right about the arguments against linkage--but I question whether, in this regulatory climate--that one can say it is of "limited concern."

Harry
NeuroInvestment
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