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Re: jaybe post# 21382

Monday, 08/27/2012 9:49:07 PM

Monday, August 27, 2012 9:49:07 PM

Post# of 80490
I think we're talking apples and oranges.....I was referring to the following:

A request for Priority Review must be made by the drug company. It does not affect the length of the clinical trial period. FDA determines within 45 days of the drug company’s request whether a Priority or Standard Review designation will be assigned. Designation of a drug as “Priority” does not alter the scientific/medical standard for approval or the quality of evidence necessary.

We requested Priority Review Consideration on July 30th......I don't believe the tiny supplemental data now pending is relevant.....The news flow for Ponatinib is likely to start with the following Headline: FDA Grants Priority Review To Ariad's Leukemia Drug Ponatinib...and of course we hope followed by approval for refractory and T35I patients....:0)
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