I am somewhat at a loss as to why the IND filing for the ADHD Phase 2b is not already in the hands of the Psychiatric Division of the FDA.
While I understand that it is never quite as simple as it may appear to be, on the other hand Cortex has been sitting in a dead calm for sixteen months. I would think that during that time, the submission for Phase 2b would have been prepared except for "filling in the blanks" regarding the lifting of the dosage hold.
What am I missing here? Two weeks would be the maximum amount of time I would expect before the FDA had the submission. Heck, work around the clock to polish it up and get it in. Any thoughts would be welcome.
Cordially,
RBlatch