Jerry, Concerning an RD partnership -
From a potential RD partner's perspective, while the RD 1+2 results were good, a difficulty for them going forward is how to design a pivotal trial for the RD indication? FDA approval presumably can't be based on the rebreathing protocol used in RD-1/RD-2, or on mere changes in basal respiratory rates, etc. They'll have to design a clinical trial in a real world setting, like post operative surgical pain for example.
But as Neuro indicated -
>>> There is the as-yet undefined question of how one will prospectively test RD prevention in a Phase III--how many patients will have to be run in order to test an Ampakine's effect on a phenomenon which may happen less than 10% of the time in the controlled environment of a clinical trial. <<<
>>> To do the Phase IIb and Phase III trials to prove the worth of CX717 in acute/emergency RD, they'll have to prove it 'in the field', not in a controlled lab situation as Phase IIa was--and that turned out to be anything-but-controlled by the CRO. Given that the target event is relatively uncommon, and would become even less common in the more rigorously monitored climate of a clinical trial, waiting for enough cases to come through to generate enough of a database to establish superiority to naloxone will not be a rapid or inexpensive process. Maybe there'd be some alternative that the FDA would buy--one does not occur to me at the moment. <<<
So coming up with a workable pivotal trial design strategy could lengthen the time it takes to find a partner and ink an RD deal.
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