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K-G

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Alias Born 10/25/2006

K-G

Re: gfp927z post# 7676

Thursday, 07/26/2007 1:22:11 PM

Thursday, July 26, 2007 1:22:11 PM

Post# of 51453
I am very confused by the references to continuing holds. The progression of events has gone exactly as Cortex outlined in earlier press releases, with the exception of the FDA response taking longer than initially predicted. It is clear that THE hold placed on CX717 was lifted. The interesting part is that the FDA lifted its hold after only a preliminary review of the data provided by Cortex. This means that the submission data is indeed compelling as Cortex has stated. It also means that the hold release needed a formality caveat that some additional requirements may be levied as the full submission is reviewed. Cortex needs to allow for at least some of this review to take place prior to filing any new INDs for the same compound. I'm sure there will be continued discussions between Cortex and the FDA regarding the finding, and I expect Cortex to be fairly confident in the response when the IND is filed. As for upcoming PRs, I expect the next PR to be something like a simple "Cortex has submitted an IND to Psychiatry for a ADHD PII study."
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