LLY supposedly had problems with 'pre-seizure' activity--or overt seizures--in their human testing with their high impact. LLY's ampakine program is not worth an inch of their share price. It is not what the street is waiting for or interested in. It's not like a Prozac type of priority or stage of development. How many stage I programs do they have? plus their secretive to begin with. If a phase I program at LLY or MERK shows problems or toxicity, is that material?
Cortex, by contrast, has one clinic-ready ampakine CX717. The fate of CX717 is central to the share price. We have been told that a. the initial problem was seen in animal testing. b. Cortex felt it was an anomaly and c. The FDA did not and issued a hold. d. Cortex devised a plan with hyperacute testing to rectify their concerns and e. began another three month toxicology test over the Summer.
Knowing the exact nature of the anomaly is not a trade secret, although the plan of attack used by Cortex to alleviate the FDA's concerns may be. I agree with not giving your enemies any ammunition, but my previous concern(s) about the communication between Cortex and the FDA have not been fully alleviated(six months and counting after the hold was lifted).
My point here is not to blast Cortex. I think Roger and company have done fine jobs. Stoll has many hats in the air. His is not an easy job. But it this next press conference is another 'trust us on faith' type of operation AND then more delays occur at year end without a clear, concrete explanation of just what the 'anomaly' was in the first place, then angst is generated for no reason.
Personally, I hope and believe that Cortex saw something they felt wasn't important the first run around(and that is encouraging), and I believe the hold will be lifted completely--give or take a few months c 12/06, but I think we're at the stage where whatever bothered the FDA in the first place is becoming very material should delays continue. How LLY or anybody else gains from a disclosure about a different ampakine family is again beyond me completely.
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