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gfp927z

11/15/06 9:11 AM

#2152 RE: jerrydylan #2150

Jerry, I figure that before any deal happens, Cortex and BPs at a minimum need to first see the new tox data (which should happen by year end). Then, depending on those results, we have various possible scenarios, from worst to best -

1) New data is even worse than old data, CX-717 is dead.

2) New data is same as old data. Dosing limits stay the same (AD possibly viable, ADHD non-viable).

3) New data slightly better than old data. Dosing limits lifted modestly (AD probably viable, ADHD still non-viable).

4) New data moderately better than old data. Dosing limits lifted moderately (AD clearly viable, and ADHD possibly viable).

5) New data strongly better than old data. Dosing limits lifted almost completely (AD and ADHD both viable).


Of course getting the various data results listed above doesn't necessarily guarantee any particular FDA response on dosing liberalization, so a pharma partner may want to wait for the actual FDA decision (Q2-07) before doing the partnership. Cortex may also want to wait, since with a good FDA decision in hand we could drive a harder bargain in our BP negotiations (of course on the other hand, we could have what we think is good new data and still get the cold shoulder from the FDA, which all has to be factored into our deal making strategies with BPs).