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neuroinv

11/11/07 3:16 PM

#13504 RE: food4thought #13503

My interpretation of 'inactivated' is different. Had they 'withdrawn' it, as is often the case when a filing goes awry with the FDA, they would have had to go through more of a bureaucratic process to bring it back to Psychiatry if they decided to do so. That would have been 'pulling' the IND. By 'inactivating' it, it leaves it in limbo at the FDA, but with the admittedly very very small possibility that discussions with the FDA could cause it to be 'reactivated.'

I said this previously--the silver lining to the lack of a letter is that there is nothing in writing that would make the FDA look foolish if they were to reach an accomodation with Cortex. Cortex would not be better off if they had 'withdrawn' the filing, and they probably would not be better off with a formal letter at this point. A formal letter would rigidify the status quo. It is probably moot, since the likelihood of the FDA turning around and allowing the IND, even with stringent oversight, is--well small enough that I don't even care to make up a number. Not impossible, but real small, small enough that I don't even permit myself the fantasy.

NeuroInvestment