RespireRx Pharmaceuticals Inc (RSPI)

[scstocks]

Slightly OT- FDA environment.

I found this while researching another stock. It talks a little about the current FDA environment with respect to sleep drugs. I put in bold what I found interesting and wondered if it translates into other areas of FDA scrutiny.

"Next, just a couple of thoughts on the regulatory environment. While we all operate in an environment of increased scrutiny by the FDA, we believe, based upon statements by representatives of the agency that the regulatory requirements for insomnia agents have not changed. That is, for the broad primary market, you must successfully complete two pivotal studies in insomniacs and two in the elderly.

There's been some confusion on this issue since last December, when another sponsor received an approvable letter on their insomnia application. Specifically, there have been questions around whether the FDA will, as a general rule, require additional large studies such as comparative safety studies for approval.

As many of you are aware, Russ Katz, head of the Neuropharm division of FDA, spoke at the Sleep Research Society's Sleep Course in New York on April 3 of this year. At this meeting, Dr. Katz communicated two things that are particularly noteworthy. First, he confirmed that the regulatory requirements for sleep drugs have not changed, noting that any issues encountered by specific drugs under review are unique to that drug. Second, Dr. Katz indicated that the FDA has a heightened interest in patient-reported outcomes, an area where adipiplon has shown very robust results."

http://seekingalpha.com/article/79538-neurogen-corporation-q1-2008-earnings-call-transcript?source=yahoo