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.
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