No only those in the gene therapy, cell therapy or vaccine sectors. Small molecules and antibodies are regulated by a different division called CDER.
It would seem Vinay's appointment is really designed to block mRNA vaccines (a MAGA hobby horse), but Vinay has strong opinions about many things that will effect every therapy regulated by CBER. For example, he doesn't think new cancer treatments should be approved on the basis of proxy endpoints like PFS, only OS (overall survival). If the CBER requirement becomes that you need to show OS data to get approval then cell therapy trials (e.g. CAR-T) will take far longer and cost much more.
IMU Price at posting:
2.2¢ Sentiment: None Disclosure: Not Held
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