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Re: None

Wednesday, 07/25/2007 10:00:28 PM

Wednesday, July 25, 2007 10:00:28 PM

Post# of 57939
Another point about the Phase 2b IND protocol is that the Pharma who ultimately gets CX-717/ADHD may decide to file different Phase 2b INDs of their own anyway, and perhaps more than one (once/day dosing, BID dosing, various patient subsets (inattentive with/without hyperactivity), etc). So the Cortex IND may represent more of a general blueprint for the ultimate Phase 2b. What Cortex's IND approval means to investors though, symbolically, is that any remaining doubt about CX-717, its ability to be partnered, and indeed about Cortex's future as a company, are dispelled for good.

I wonder if after they complete their review, Neurology will give a final official decision to Cortex relating to the histo/artifact issue that will necessitate a separate press release from Cortex? Or perhaps that news will be combined in the press release announcing the filing of the IND with Psychiatric? Or perhaps the IND filing press release might not actually mention the details of Neurology's decision (it being assumed to be positive)? It would be nice to know some of the details of Neurology's dosing liberalization as early in the process as possible (BID and once/day dosing levels allowed, duration length of trial allowed, etc).

Or is Neurology only going to rule on the histo/artifact issue in general terms (thumbs up or down), with the actual dosing limit details left up to Psychiatric for ADHD, or to either division when additional INDs are filed for future indications?






















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