The fat lady (FDA) hasn't sung yet folks, so it's too early to start writing off CX-717 or Cortex. While CX-717 is most likely dead for ADHD, there's a decent chance that it can still be partnered for AD. Here's a likely scenario/timeline -
By early 2007 - Cortex raises approx $10-12 mil from the shelf.
End of Q1-07 - Cortex submits complete package of the new tox data to the FDA.
Mid Q2-07 - Cortex gets FDA's reply on dosing liberalization.
Summer-07 - Possibility #1 - Assuming AD is viable based on CX-717's allowed dosing, a N.Amer Neurodegenerative deal is done with a BP interested in AD.
Summer-07 - Possibility #2 - If AD doesn't look viable based on CX-717's allowed dosing, a smaller N.Amer Neurodegenerative deal could still be done, with Organon likely being the most interested partner (since they already have Org-24448 and Org-26576).
Wildcards - There is an outside chance, unlikely but not impossible, that the FDA could liberalize CX-717's dosing enough to make it viable again for ADHD. In that case Cortex is a homerun stock.
Other considerations - Assuming that one way or another the N.Amer Neurodegenerative rights get partnered next year (#1 or #2 above), the question then becomes whether to try to carve out ADHD from the deal. Some orphans will likely be carved out and available, but getting ADHD carved out would allow Cortex to put all its energies into a low impact backup (like CX-701) for ADHD, with the goal of partnering it a couple years later. The other key priority is to get the lead high impact (CX-929) into the clinic, after which that could also be partnered to the BP who has the N.Amer Neurodegenerative rights. Those two activities (CX-701 for ADHD, and CX-929 for Neurodegenerative, both to be outlicensed after/around Phase 2) would be Cortex's central focus for several years, and the non-Ampakine in-license idea could be shelved.
Summarizing, the above is the best fallback scenario I can come up with. Of course if ADHD becomes viable again for CX-717, then we're golden, but the odds are pretty heavily stacked against that scenario. Biotech is full of surprises though, so you never know.
