The single persistent hope for Cortex at this point is the fact that--once again--a lot of public attention, and the FDA's, is being focused on the issue of opioid painkiller risks, both in terms of overdose and abuse.I don't know of any other technologies that are in development for, let alone with hint-of-concept in, preventing opioid-induced Respiratory Depression. Thus as I have said several times before, it is utterly baffling that no company or (less likely, but possible) investor has seen enough potential here to buy into the RD program. That is primarily a reflection on the pharma industry and its associated investors at present, overgeneralizing from a long history of frustration and failure in AMPA modulation, most of which occurred at companies other than Cortex.
The FDA is having a public hearing in February on the opioid analgesia issue overall. Just to give an example of the way the FDA and its Advisory Committees sometime think (not necessarily in unison), the Zogenix opioid Zohydro recently had its AC vote 11-2 against approval. The reason wasn't Zohydro per se--that being the first hydrocodone painkiller not accompanied by acetaminophen, which raises possible liver toxicity issues in itself--it's as effective as those already on the market, and no more prone to abuse--but the AC is unhappy with the failure of current regulations to circumscribe opioid abuse. Zogenix just happened to be on the docket when they decided to make a statement, and hence was the scapegoat.
Gfp follows Cortex finances closer than anyone I know outside the company, but I suspect that Cortex is no longer able to pay salaries, whoever is there is working pro bono at the moment, and Maria Messinger's departure is probably a reflection of that fiscal reality.
So, RD is Cortex's main ticket to survival, and I havent the faintest idea whether anyone is going to respond to the obvious and take a shot.The fact that longterm use of AMPA-modulators is currently seen as risky by everyone but Servier is a deterrent, though one could argue that in a terminal cancer population dependent on opioids for even a minimal quality of life, time-limited as it is, ambiguity around longterm safety should not be the barrier to entry.
NP
