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Re: Amatuer17 post# 125185

Saturday, 10/10/2015 1:19:02 AM

Saturday, October 10, 2015 1:19:02 AM

Post# of 402812
Besides the normal criteria for fast track, being declared a QIDP automatically makes a drug candidate eligible for fast track.

Not sure your definition of fast track is correct. See below - fast track is granted even in phase II and supposed to be given for treatments for unmet demand - B may not fall into this category as there are many ABSSI treatments.

"Merck KGaA MKGAF and partner Pfizer Inc. PFE announced that avelumab received fast track status from the FDA for the treatment of metastatic merkel cell carcinoma (MCC). The candidate is being evaluated in a phase II study, JAVELIN Merkel 200, for this indication.

The FDA usually grants fast track status to candidates that are being developed as potential treatments for serious conditions and are considered to be capable of addressing an unmet medical need. "
- Amatuer17


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