MarketFest, In the conf call, Dr. Stoll said he expected the full package of new tox data to be submitted to the FDA by the end of Q1-07. I figure the FDA might take around 6 weeks or so to decide (I don't think there's a 30 day turnaround guarantee this time), which would put the FDA dosing liberalization decision around the middle of May.
Cortex will have the raw data long before that however, though I guess it takes quite a while to do all the analysis and get it packaged together. One might expect interested BPs to possibly see the data prior to submission to the FDA, though I doubt a licensing deal will be done before getting the official dosing verdict from the FDA, though you never know. It's probably in Cortex's best interests to wait for the FDA's official decision, to avoid getting lowballed by BPs.
If the FDA doesn't allow much/any liberalization of the dose, Cortex could still do a pharma deal for the N.Amer Neurodegenerative rights without CX-717, particularly with Organon who already have several other compounds they could use. Or Cortex could choose to keep the N.Amer Neuro rights, but then we're faced with raising more money again (another shelf offering).
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