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Re: ATLnsider post# 459698

Friday, 04/15/2022 6:40:34 PM

Friday, April 15, 2022 6:40:34 PM

Post# of 702062
ATLnsider,

You said:

'the FDA approved the Medidata synthetic control arm, based on external historical GBM trials, in October 2020.'



Not exactly.
Here is a quote from John H. Sampson, MD, PhD commentary on MDNA55 planned Phase 3 Trial with an External Control:
6:46:40
SNO 2020 Think Tank on Neuro-Oncology Clinical Trials-November 6, 2020.

'To be clear, it hasn't been formally approved by the FDA yet but we did have a very..hm.. a good conversation with them ......'

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