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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: aknahow who wrote (6381)	1/28/1999 7:29:00 AM
From: Rocketman	Respond to of 9719

Well, the big breakthrough they seem to be having is that the FDA has made the existence of these meetings official, and have put a time frame for the FDA to get back to their customers and actually schedule a meeting in a timely manner rather than shining you on for ever with lame excuses and avoidance. Now, will what they advise you at those meetings be binding on the FDA, so that if they tell you a clinical path that is OK with them that they won't change their minds on criteria after you've produced the data?