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TheDane

12/09/14 5:16 PM

#81385 RE: smilingra #81384

I assumed so as well. Here is a list of the four categories under QIDP...I didn't realize we were only given Fast Track. Is that true?

Pages 7 thru 10.

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf
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TheHound

12/09/14 5:24 PM

#81388 RE: smilingra #81384

Leo has hinted they're going after a First in Class Designation for B. We shall see. So exciting.