RespireRx Pharmaceuticals Inc (RSPI)

[gfp927z]

Just rambling here, but concerning the Narcolepsy "orphan / back door" approach to approval (the modafinil/Cephalon route), there are several things that bother me about this approach as a potential road to approval -

Will the new/improved hyper-cautious FDA fall for this a second time? Years ago they allowed modafinil to slip through via the orphan Narcolepsy indication, and then watched as its off-label use (and misuse) exploded. Schools are now inundated with the stuff (along with Ritalin/methylphenidate and amphetamine based ADHD drugs). The way they recently shot down modafinil's latest attempt at label expansion (into ADHD) was particularly telling (the extremely lame skin rash excuse).

The FDA has gotten so much flak over ADHD/CNS drugs in the past few years, with weird side effects and black label warnings, etc, that it just seems like they want to stonewall anything and everything CNS related. I wonder how much of a factor that could be with CX-717 right now. CX-717 didn't have any FDA problems at all until showing those phenomenal ADHD results, and then wham, the FDA pounced immediately. I can't help thinking the FDA has overreacted into a general circle-the-wagons mode, especially with CNS and ADHD. Plus the FDA is currently going through a major restructuring of the CNS division, dividing it into separate Psychiatric and Neurological sub-divisions. So general disarray at the FDA could be a large part of CX-717's current troubles.