RespireRx Pharmaceuticals Inc (RSPI)

[neuroinv]

While I do not claim to be an expert regarding the minutiae of FDA regs, I have the feeling that you are making this up as you go. The IND requirements state:

<<A brief description of the overall plan for investigating the drug product for the following year. The plan should include the following: (a) The rationale for the drug or the research study; (b) the indication(s) to be studied;>>

There is nothing about a one indication 'freebie' piggybacking on the first, it simply notes the possibility of multiple indications. And it should be noted, Cortex ran trials in three indications, not two: AD, ADHD, sleep deprivation.

In addition to the fact that there is now a new division involved, the previous IND's one year plan duration has long expired. Given the division bifurcation, the delay due to the hold, and the fact of the hold itself, it is perhaps not surprising that the Psychiatry Division wants a new IND filed.

Feel free to point me to any FDA regulations that indicate otherwise....

NeuroInvestment