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Re: gfp927z post# 24686

Tuesday, 03/31/2009 3:00:10 PM

Tuesday, March 31, 2009 3:00:10 PM

Post# of 52265
Your recall may well be better than mine, but I thought Varney was referring to an ADHD trial when discussing the Q2-Q4 timeframe.I don't think Cortex wants to be the company running a multiple dose sleep trial, they want that partnered. Of course, there is no money for any multi-dose trial in either disorder. They have enough to finish the single dose SA trial, that's it.

The sleep apnea trial, as I understand it, is a single dose trial, following two sleep sessions where the baseline apnea frequency, including the all-important consistency of scores across nights, is established. DavidAl undoubtedly has a better sense of exactly how the apnea episodes are measured and defined, but this is a pretty standard process. The added element is the need to carefully establish that each patient has sleep apnea, and that it affects them with the severity each night. Otherwise, you won't know if a change was due to variability in the baseline rate, or due to drug.

I don't know if they are including CPAP patients, since that would raise some ethical issues of withdrawing effective therapy. There is no shortage of SA patients who are not on CPAP because they hate it.

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