Exactly, all that fast track designation, rolling review meant little And again it was claimed that the FDA had agreed a single arm open label trial for ethical reason (minute 8:30 this video https://youtu.be/Zvwdxn93kMU?t=222 ). I mean an important agreement like that couldn't just be done verbally over a cup of coffee. What surprised me is that there was no mention of such agreement in the ODAC meeting and the update announcement and IS's webcast after the CRL.
Exactly, all that fast track designation, rolling review meant...
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