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Re: haysaw post# 27202

Friday, 07/03/2009 6:00:39 PM

Friday, July 03, 2009 6:00:39 PM

Post# of 52265
<<IF, they muster up a partnership, it will be disappointing>>

That's certainly possible. I am sure that some people will end up complaining about terms, whatever they are. It's possible I could be among them. The Acadia/Biovail deal shows that it is not impossible to get decent terms in this environment, albeit with the caveats previously noted.


<<I also feel ADHD is dead until they get Ampakines approved in something else--once long term human safety data is established, and the risk/benefit ratio changes. I don't think too many companies will take the risk given the current FDA climate, or Europe's [equivalent] agency for that matter.>>

This presumes that there are fears of a 'class effect' for all Ampakines, that will taint their use for ADHD until proven elsewhere. The fact that Organon was allowed to run a Phase II trial in ADHD using the Ampakine Org26576, after the CX717 artifact issue had already arisen and been left unresolved, indicates that the FDA is not assuming a class effect, and is not deadset against the concept. And while we don't know anything about the efficacy data, we do know the trial was completed, thus no safety issue either precluded the study, or caused its termination. Which means that companies involved in ADHD will not see this as a locked gate.

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