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stugwins

Re: antihama post# 1930

Saturday, 11/11/2017 10:40:29 AM

Saturday, November 11, 2017 10:40:29 AM

Post# of 3283
Antihama, 505b2 is only for NDAs (i.e small molecules). The equivalent for BLAs is 351k. Rolontis is a biologic so no 505b2. So what is the regulatory strategy on Rolontis? 351a or 351k?
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