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Market_Fest4

10/16/07 1:54 PM

#11436 RE: nakedmouse #11432

I'm just saying that what he says is no big deal. Of course one would call into question the Ampakine platform after an FDA rejection. I did it myself.

My conclusion is that the FDA psych division are a bunch of cowards and took the easy way out. Unfortunately, I believe that whatever ampakine is submitted for widespread use will be excessively scrutinized. Almost all drugs have minor side effects (like an erection lasting more than 4 hours), but the FDA lets them go to market. I believe if a BP sponsored the Ampakine, the FDA would be more constructive.

As such, I think CORs best path would be getting something approved for an acute condition. Once an ampakine is available (and a revenue stream), then COR or a BP partner can try to expand into a mass market indication. I think Stoll realizes this too and will say so in a CC.
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gfp927z

10/16/07 2:14 PM

#11439 RE: nakedmouse #11432

Mouse, Cortex and Dr. Lynch have had a lot of detractors over the years, and the AMPA upmodulation concept was originally viewed with extreme skepticism in scientific circles. However, as the recent LA Time's article noted, Lynch's AMPA centric view of LTP/memory is now pretty much the consensus view. Dr. Lynch made a lot of enemies over the years though, and some of them are probably happy to gloat over Cortex's current misfortunes.

There are numerous facets to the Psychiatric decision, but as Neuro pointed out, probably the most important one is the current hypercautious mindset at the FDA over ADHD drugs. This factor likely outweighs everything else, and stacked the deck against us. Other likely factors include previous AMPA related failures "poisoning the well" to some extent (LY-451395, CX-516), antagonism to Lynch, etc. Who knows, there might even be some legitimate FDA concern over the possibility of actual long term AMPA toxicity. Extreme FDA butt covering is most likely the main factor though.

Regardless, this leaves Cortex in a real pickle, with its future prospects in serious question.