What does that even mean? 'Aggressive' would have to mean going to the media, since it takes months to even get a meeting) If you were to poll Pharma/Bio CEO's regarding: Should a tiny company be 'aggressive' with the FDA vis-a-vis a non life-threatening condition matched with a drug the FDA thinks could be a safety risk?
I suspect that you would get a unanimous, or close-to-unanimous, vote of 'No.' Vanda paid $5 million to a 'consultant' who was able to get the FDA to approve iloperidone for schizophrenia. Iloperidone is just another me-too drug, and that's what it cost to get it done. The guessing is that it was Paul Leber, former CNS Division head, who 'got it done.'
But there was no novel mechanism/fear of unknown safety hazard with iloperidone. My guess is that Cortex asked their consultant (whoever that may be, could have been Leber for all I know) whether there was any possibility of progress for CX717 in ADHD, and were told 'No.'
Do you truly believe that bashing one's corporate head against the FDA wall would have been a better use of cash than going after sleep apnea? Genius!
NeuroInvestment
News 
Market Data 
Discover 
AI
