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Re: glass_half_full post# 245

Tuesday, 06/08/2010 9:26:53 AM

Tuesday, June 08, 2010 9:26:53 AM

Post# of 80490
One thing that gives me a lot of confidence that the fda will approve the AP534 registration trial is the response that Omapro got from the FDA's Oncologic Drugs Advisory Committee earlier this year. Even though they got a complete response letter rejecting their NDA, 4 of the 7 panel members said "Omapro was effective against the disease" even though the MCyR was only 15%. At ASCO, Ariad reported a 57% MCyR in the same patient population (Chronic Phase CML patients with T315I mutation)

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