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Biotech / Medical : Agouron Pharmaceuticals (AGPH)

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To: David S. who wrote (1006)	7/17/1997 11:39:00 PM
From: JOHN W.	of 6136

July 14-15 FDA ANTI-VIRAL ADVISORY COMMITTEE MTG More good news this week for AGPH. There was a unanimous decision to endorse inclusion of viral load measurements as a clinical endpoint criteria in determining full regulatory approval of new antiretroviral therapies. Changes in viral load directly correlates to disease progression and survival. This decision is very positive to AGPH for two reasons. A) FULL APPROVAL FOR VIRACEPT WILL COME SOONER THAN EXPECTED. B) NEW THERAPIES WILL HAVE TO DEMONSTRATE EQUIVALENT EFFICACY TO CURRENT COMBINATIONAL THERAPIES. NEW THERAPIES WILL REQUIRE LONGER AND LARGER STUDIES TO DEMONSTRATE EQUIVALENT DURABILITY, THEREBY INCREASING THE DIFFICULTY OF FUTURE COMPETITION TO GET TO MKT AND COMPETE AGAINST VIRACEPT. Could be another stumbling block for VX-478?

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