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Re: Aiming4 post# 2091

Wednesday, 11/08/2006 4:05:42 PM

Wednesday, November 08, 2006 4:05:42 PM

Post# of 52042
Aiming, I don't know, it's extremely risky. More likely what will happen is that we'll get some modest dose liberalization, enough to make AD more palatable to BPs, but not enough to really create much hope for ADHD. That wouldn't be the end of the world, since a BP deal for AD could still be a halfway decent payday for Cortex. But ADHD appears to be the biggest prize here from a dealmaking perspective, due to the stellar Phase 2a results.

What I'd like to know is the actual human oral dose level/duration combinations that are currently allowed by the FDA, or even a fairly close ballpark figure. That would give us a much better idea how much of a dose liberalization we need to get from the FDA in order to have any hopes for ADHD. I have a feeling that the dose restrictions are fairly loose for a single dose type study (as in the AD PET scan), but far tighter for longer duration studies (since longer term dosing was where the histo finding was seen in animals).

I don't know, but from a betting/odds standpoint, to me CX-717's viability for ADHD seems like a low percentage bet. It might happen, but I suspect that at best the dose liberalization we get will still only make for iffy ADHD prospects from the BP's perspective (the dose allowed will still be on the low side).
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