What evidence do we have that FDA's reviwed devision was based on change or update in their procedure/process, or was it based on MSB providing more (convincing) data/response?
The new draft guidance from September 23 - “Demonstrating Substantial Evidence Of Effectiveness With One Adequate and Well Controlled Clinical Investigation and Confirmatory Evidence”. That was the tipping point, imo. So whether the new/re-analyzed data presented to FDA made a difference, it's hard to tell given the submission and response which resulted in the 2nd CRL (August 2, 2023) preceded the release of this guidance (September, 2023).
Without ripping too much more from the BP report, here is another opinion on the potential reason the FDA change it's position on MSB's clinical data...
What evidence do we have that FDA's reviwed devision was based...
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