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Re: erbse24448 post# 4049

Friday, 02/23/2007 4:07:43 PM

Friday, February 23, 2007 4:07:43 PM

Post# of 57986
Erbse, I hope that's what it means (enrollment completed?) -

>> This study is no longer recruiting patients.<<


Concerning Stoll's strong desire for an in-licensed program, in addition to those reasons, it might also have to do with his cooling on the Nacolepsy/EDS/Sleep Related indications to some extent, as well as the expectation that the CX-717 BP deal might need to include the backup CX-701, leaving Cortex with only CX-1501 which is further behind.

Looking at the possible remaining indications for Ampakines available post-BP deal, some of them may ideally require a high impact (Frag-X, Huntington's, ALS, Retts), but of course there won't be any high impacts clinic ready for quite some time. Other indications which would be suitable for low impacts, like post-ECT, may not look all that attractive to Stoll. That would leave the Sleep Related/Narcolepsy/EDS area, but it would have to be carved out, and doing so might lessen the terms of the CX-717 BP deal considerably. In addition, after the negative DARPA experience, Stoll may not be as keen on the Sleep Related areas generally.

So, the solution would be to in-license, which also broadens the pipeline to a completely different platform, gives an instant Phase 2 visibility to the company, etc.

I was very high on the Narcolepsy/Sleep idea a while back, after the UK Sleep study. Something I wonder about though pertains to the FDA's view of Narcolepsy as a sneaky "back door" into all kinds of off label mischief (ala Cephalon and Provigil). Perhaps one might expect the FDA to be a lot more cautious in approving something for Narcolepsy again, since they were burned already by Cephalon (burned in the sense of the door being opened for zillions of off label modafinil uses and abuses, and a general headache for the FDA). Narcolepsy/Sleep Related is arguably the best suited remaining indication for low impacts, but perhaps its luster has diminished for some of the above reasons, making the non-Ampakine in-licensing all the more attractive to Dr. Stoll.

Neuro mentioned the CX-717 near death experience, and that may have been the biggest factor of all in pushing Stoll further toward the in-licensing approach. There's nothing quite like a brush with the old grim reaper to get the mental gears spinning overtime in a survival mode.








































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