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gfp927z

06/27/09 9:55 PM

#27096 RE: neuroinv #27095

Neuro, One thing about the Org-26576 ADHD trial -- I hope they dosed high enough. According to Clinical trials.gov, their protocol was to dose from 100 mg BID to 300 mg BID. As we know, CX-717 showed no effect at 200 mg BID, and good effect at 800 mg BID. We didn't get data for the intermediate doses, but it's likely that for CX-717 it would take approx 500 mg BID or higher to get good ADHD efficacy. 300 mg BID wouldn't cut it using CX-717, so Org-26576 had better be considerably more potent than CX-717.

BTW, the Org-26576 Depression Phase 1/2 used 100 to 400 mg BID, and they were planning to go to 600 mg BID in the Phase 1 portion to get MTD. In contrast, MTD for CX-717 was 800 mg BID (though we never did get any SAEs).

So it looks like Org-26576 is likely somewhat more potent than CX-717, but I still wonder if 300 mg BID in the ADHD study was high enough. I guess they could always modify the protocol and escalate the dose higher, so hopefully they did that if needed. Of course this is all moot if the Merck merger effectively prevents any dealmaking for ADHD/new compounds.

























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haysaw

06/27/09 10:36 PM

#27097 RE: neuroinv #27095

<<Since I don't know how those trials turned out, it's impossible to guesstimate.>>

Would there be any sensible or logical reason to withhold a positive result [for any party involved] with these studies, which most likely have been completed for several months now?

The only one I can think of would be a partnership negotiation. But as the months go by with no evidence of interest--not even as much as a life preserver, as we barely percolate (let alone breathe) at the surface of the water--my doubts on efficacy are high, and my hopes are low.

Is there any reason to be confident about the outcome of the Organon/SGP studies?