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Biotech / Medical : Cortex (Cor) [formerly CORX] -- Ignore unavailable to you. Want to Upgrade?

To: NeuroInvestment who wrote (1071)	3/11/2006 6:27:36 PM
From: DewDiligence_on_SI	Respond to of 1255

For some reason I can't post on Yahoo right now, so I’m replying to your post (#25657) over here: >Maybe they'd try a 1000mg dose just to establish the practical MTD, but I do not think that they are aiming for higher doses than were used in this Phase IIa. They said as much during the CC, when they said they chose doses at the extremes.< But I interpreted that comment to refer to the daily load, not the individual dose. I don’t think you can entirely discount the effect of the evening dose on blood level the following morning. If the half-life is 10 hours, you presumably have 30-40% of the previous evening’s dose still active at 8 am. Moreover, the half-life may well be longer than 10 hours in some patients. I guess we just disagree on this. I’ll be surprised if 400-600mg once-daily proves to be the optimal dose. >You are right that titrating the dose up over the first few days is certainly possible, as is done with a lot of Provigil patients.< I’ll flip this around and say that I would find it odd if COR did not make titration part of the indicated regimen. If nausea is an issue, why would you not want to titrate? Byetta for type-2 diabetes has had a very successful launch in part because AMLN and LLY made titration virtually a requirement. They gave out thousands of 5mcg samples and instructed docs to prescribe the regular 10mcg dose when a patient exhausted the sample. Nausea, which was a common AE in the Byetta clinical trials, has been close to a non-issue since commercialization. Regards, Dew