I don't seem to remember a differentiation with the Neurology hold and the Neurology lifting relating to short term and long term dosing, only relating to Cortex planned testing which comprised of short term testing-AD. But since we as investors have not had the privelege of reading the actual Neurology correspondance, there is that possibility.
The sudden emergence of RD, didn't that come straight out of Alberta, more of a new clinical pathway from that point of time, and since this happened recently, it is a sudden emergence but would only be an acute fallback option if there was no Alberta influence.
The FDA mentality towards lifetime ADHD drugs, you may be correct, we perceived CX717 to be very safe at utilized dosages but not enough thought was spent of the possibility of any artifact no matter what dosages in testing at nullifiying the perceived safety.
Time for a play of words which has been lightly discussed here and there;
Upon the telephone call Oct 11, Cortex "inactivated" its IND.
What does "inactivated" mean in relations to what the FDA needs to do- ie no longer needs to send a letter,, or no longer needing to follow a timeframe for the letter
Initially I felt inactivated would be the same as withdrawn, not in a hold pattern, but taken out of the process completely.
What are everyones thoughts on how we can interpret "inactivated" from Cortex and an FDA standpoint
What also could be interpretated from the time period Oct-11 to current and what from a longer time period without us knowing of a formal writtent FDA response.
The longer the time between the inactivation and any formal FDA letter from our awareness, it would seem the greater the likeliehood for correspondance to be going on and possibility of Cortex modifying its IND testing/monitoring procedures toward to something that shows the carefullness of the FDA in scrutinizing new drugs.
Wishful thinking at its worst, what would happen to the SP if news came out FDA agreed to a modified IND with CX717 with special new testing procedures due to the artificat.
