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Strategies & Market Trends : Roger's 1998 Short Picks -- Ignore unavailable to you. Want to Upgrade?

To: Bill Wexler who wrote (11571)	7/15/1998 10:01:00 PM
From: Hank	Read Replies (2) \| Respond to of 18691

I've been in the pharmaceutical industry for a long time and I have never heard of a company intentionally requesting that a filing be put on the back burner. If a filing is put on the back burner, it's because the FDA has determined that it is not a high priority for them. To think that a company would spend all that time and money to file an NDA just to request that it be intentionally held back is ludicrous.

To: Bill Wexler who wrote (11571)	7/15/1998 11:10:00 PM
From: George Acton	Respond to of 18691

Someone said there's a flow chart at the FDA site showing the steps. I've read that they can't ask for fast-track because there's already an approved drug for the indication (Viagra). Obviously, the procedure has to be very flexible, considering the huge range of issues and considerations they're trying to cover. But the usual process is that it would be given a preliminary examination by the FDA's in-house people, then submitted to a "review panel" of outside experts and considered at a hearing of the panel. The FDA usually, but not always, follows the recommendation of the panel. One possibility is that a drug can be rejected before submission to the outside panel. When that occurs, there's not necessarily a warning in the stock price. The FDA might tell the company to expect a report shortly, and they might leak. But the FDA has a clean record concerning leaks to Wall Streeters, AFIK. The scandals that brought down their morale before Kessler's time concerned bribes by drug companies for tampering with the internal decision process. --George Acton