Unless there is something about the FDA and their view of sleep apnea that I am completely unaware of:
It's a 120pt Phase II trial, just two clinical sites. That is enough to provide data supporting a larger scale Phase III trial upon which NDA filing would be based. But I am not aware--in the neuro sector--of such a small Phase II ever having been sufficient for approval. Maybe in oncology...
There are some programs that are using their first actual efficacy trials as their pivotal trials for NDA submission: The huge Alzheimer's trials of monoclonal antibodies and BACE inhibitors, and maybe more to the point, Biogen/Isis Pharma's trial in spinal muscular atrophy. The latter is a relatively small trial, but it is in a rare, devastating genetic disorder.
Sleep apnea is not a small population, and is does not fall under the usual definitions of 'life-threatening'...even though it is deleterious to health; and there is effective treatment available, even if highly flawed and problematic (CPAP). I see no way that the FDA would even accept the filing of an NDA based on this Phase II.
Prospects for Cortex? They depend upon whether Arnold Lippa is able to obtain enough funding to run the trials he needs to run--or at least, to stay functional until the dronabinol trial finishes and hopefully shows positive results....
NP
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