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Biotech / Medical : ADVR and ONLY ADVR

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To: Bernie Bildman who wrote (91)	9/27/2000 3:02:20 PM
From: Kingfisher	Read Replies (1) of 278

Bernie, the logical sequence of events for obtaining FDA plant approval and for getting FDA approval for the Drug Master File (DMF) as outlined by ceoa+ over on RB yesterday, should be assumed to be being followed by ADVR in Freeport simply because it is GloboMax who is heading that effort and it is that organization that has brought Freeport up to standard. As we have been informed, GloboMax is composed of personnel with extensive experience in dealing with the FDA and who have actually worked for the FDA. As you say, "there is more then one way to skin a cat"!! They may not have followed the sequence exactly as outlined by ceoa+ but they should be knowledgeable and experienced enough to know how to get the job done and if and how they can alter the ceoa+ sequence [if they have to] without compromising their efforts. Thus, it is reasonable to accept that the necessary FDA approved product to do animal and stability testing and to have available for IND trials is being produced in Freeport and to dismiss the idea that it is going to come out of Yonkers. If one can accept this point of view than an INDA by year end is a distinct possibility — a realistic goal to accomplish.

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