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Biotech / Medical : ADVR and ONLY ADVR -- Ignore unavailable to you. Want to Upgrade?

To: Bernie Bildman who wrote (27)	9/23/2000 9:27:22 AM
From: DAN LITTLE	Read Replies (1) \| Respond to of 278

Got this from the FDA. I bet they have gone over it with a fine tooth comb and I'd also be willing to bet that they have had these pre-IND meetings, discussed below. I think that when they submit, the odds of it not being excepted the first time around are slim indeed. Timing of Submission A sponsor may submit a request for fast track designation at the time of original submission of its IND, or at any time thereafter prior to receiving marketing approval of its BLA or NDA. Note that the IND and potential fast track designation may be discussed prior to an IND submission in a pre-IND meeting, but a decision on designation would await submission of the IND.