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Re: TopPick post# 59415

Monday, 04/09/2012 8:37:21 PM

Monday, April 09, 2012 8:37:21 PM

Post# of 129051
according to this it could be 60 days 1/3 the time you posted

http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm

In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within
sixty days based on whether the drug fills an unmet medical need in a serious disease.

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