Friday, May 15, 2009 1:41:22 PM
For this trial, there is no academic involvement, and sleep apnea is a far more familiar indication for assessment, so the CRO running it will not be hostage to some rare skillset (and Cortex will hence not be hostage to that skillset as well). The question here is enrollment--they had to pretest patients to make sure that they had sleep apnea that is consistent from night-to-night, and to thus find sleep apnea patients willing and able to spend three nights in a sleep lab. This far into the trial, they'd know whether enrollment is on-track for midyear completion or not. Since they say they expect to report topline data around that time, enrollment must have been adequate, and the main threat to timely completion successfully bypassed. The factors that messed up RD are not present in the SA trial. If there is a delay, IMHO it might be a matter of a couple weeks, not months.
NeuroInvestment
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