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powerwalker

08/28/16 3:47 PM

#74368 RE: apostrophe #74356

Apostrophe, thank you for the well thought out and informative posts the last few days.

scottsmith

08/28/16 4:31 PM

#74373 RE: apostrophe #74356

I don't think you understand the differences and similarities between fast track and accelerated approval.

And Missling would not be doing his job competently if 2-73 were a candidate for either designation and he didn't apply (he may have applied).

Here are a couple links:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf

http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm

http://www.fda.gov/ForPatients/Approvals/Fast/ucm405447.htm