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Biotech / Medical : ADVR and ONLY ADVR
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To: Bernie Bildman who wrote (31)9/24/2000 9:28:14 AM
From: DAN LITTLE  Read Replies (1) of 278
 
I would like to clarify something I reported earlier plus add a little more food for thought. The initial filing of an IND, as I reported earlier, seems to have a failure rate of above 50%. This is because the FDA usually asks for more information. I cannot remember a single one that failed completely (although I'm sure that happens).

The request for more information from the FDA will result in a six week or longer (usually longer) delay before the company will refile. Then another 30 days for acceptance from the time the FDA receives it. The FDA may still request even more information and the process starts all over again.

The FDA gives out a very thorough filing packet. Most companies probably feel that they can cross all the T's and dot all the I's themselves without going to the extra expense of hiring a Globomax or setting up meetings with the FDA. The extra expense V the extra time. For a start up company I suspect most will do the time.

For a company filing an IND with fast track status I would think that a Pre-IND meeting with the FDA would be absolutely essential. We have seen ADVR give projected filing dates only to back off and project one farther down the road. Could it be the results of a Pre-IND meeting that pushed these dates back (seems as likely a possibility as anything else I've heard or thought of)?

When you think about the time it would save, in the long run, to file an IND with fast track as opposed to getting fast track later or none at all. The time spent ironing out the problems ahead of the IND will probably save 2-3 years in the overall FDA process.

Dan

PS. Lost power here yesterday afternoon and I had some really good links too. I'll try and dig up one or two again.
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