I think the issue with Psychiatry reflects an interaction between the lingering uncertainty about CX717 and the disorder under discussion. Psychiatry knows ADHD is 'real', but it also involves eventually a heavily pediatric population, and psychostimulants are very effective. Dew and I probably disagree about the salience of the problems involved (side effects and abuse) but one thing I do know--a lot of parents won't put their kids on stimulants, leaving them with near-placebo Strattera, less-effective off-label Provigil, or nothing. But that's not the FDA's concern--they will say that very effective therapy is already available, there's no reason to take a chance.
Depression might be affected by some of that. 70% or so of patients obtain at least partial benefit, albeit with annoying side effects. I think that Psychiatry might lean towards allowing Ampakine trials because of the 30% who don't, and for whom depression can be life-threatening. But I am not sure.
Schizophrenia is where Psychiatry would almost certainly allow trials. There is general agreement that cognition is poorly addressed by current drugs, and schizophrenia is so devastating that the FDA would be much more risk-tolerant, even Laughren and his Division.
My information is that Organon did some work to reassure themselves that Org24448 does not have the artifact problem.
I think EDS/narcolepsy should be on the table for consideration. My only point was that there are hurdles there, but it would be very easy to improve the trial design (No Naps!!!)
I see no correlation between hiring a former Lilly guy and the quality of the relationship with Lilly--having an ex-Lilly guy on the BOD didn't mean anything in that regard. My guess is that they hired him for his trial and regulatory experience in general, not because of specific experience with sz/depression. But it couldn't hurt--Cortex would do anything, anything...to regain those rights if Schering-Plough decides not to develop them. Hving a guy like Tran on board might make it more appealing to S-P to license the rights back to Cortex, since Cortex also has better molecules available. The problem is that GSK and Lilly would be able to pay just a tad more than Cortex if it came to an auction. It would have to be a license to Cortex with first call on acquiring them back after Phase II, for example. GSK or Lilly would never do that, Cortex would.
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