From an FDA point of view wouldn't a trial administered at arms length be of more value?
A trial run by independent clinicians shows again an integrity that the science is good... and yes we cannot influence it - which you'd never want to do surely.
Isnt it almost like being peer reviewed - either way we must be very comfortable with what we have is working if we'll are happy to save time and save dollars and have clinicians run it.
I think FDA will like this and we won't get 53 page letters admonishing us on our approach etc
think of it it as a robust confidence in the drug rather than a loss of control.
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