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neuroinv

01/21/08 5:18 PM

#14898 RE: enemem #14897

<<Ombow follows COR as closely as anyone>>

I think I'd have to disagree with that.

The assumption of a blanket pall over CX717 is also contradicted by the Neurology allowance of the Alzheimer's trial. Granted, it's an acute use trial, but it's still a different line in the sand than was drawn by Psychiatry, thus there is some variation. Also--the European authorities have apparently given permission for the RD trial, which is yet another indication of regulatory variation.

The whole issue of what Cortex should say has been discussed at length. If this hypothesis is accurate, and I believe it is, Cortex would--if they wanted to state it definitively--have to say something like: "The denial of the IND by Psychiatry was due to their uniquely risk-averse nature, not the data regarding CX717 itself." The more they euphemize, the less clear it would be. Given that they have held a small hope of working with Psychiatry on the ADHD issue, if not for CX717, for another Ampakine, I think they'd be fools to antagonize Psychiatry for no gain. The investment community is not going to take their word for it at this point--it would be different if the FDA released something, but they aren't going to.

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