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would appreciate your outtake?
Jun 14, 2004

Dr. Young,

This year has been somewhat slow in the release of new medical agents compared to last year. I know that tipranavir is in phase 3 clinical trials? Does it look like it might make it out for approval late this year in 2004, or next year? Is there are new original drug to treat resistant virus that will make approval this year? Thanks.

Donald

Response from Dr. Young

David, thanks for your post.

2004 has certainly seen fewer new products than last year-- a couple of comments are worthwhile-

First, I would view 2003 as the exception (for expectations) rather than the rule. There were more new products in 2003 than in any other year of the HIV epidemic.

Second, drug discovery continues-- we will likely see 2 or 3 new products this year. We'll very like see FDA approval of 2 new NRTI fixed dose combinations (abacavir/3TC and tenofovir/FTC); both of these combos portent 2 drug, 1 pill per day backbones for therapy.

Additionally, tipranavir will likely reach expanded access, if not filing for FDA approval. This new protease inhibitor will have activity for many (but not all) persons with HIV resistant to currrent protease inhibitors. BY



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