@@stockrock @dachopper @MJC73 - anyone else who would like to answer...
I understand that we are meeting OTAT for Potency Essays, I get that...
But, why is the P3 for C19 ARDS dependent on this potency essays?
Given that the recent trial we had, sponsored by NIH didn't have potency essays - and yet the trial was allowed to proceed.
It cannot be a safety concern, as where was the duty of care to the 222patients enrolled on the previous C19 ARDS trial?
So I can only conclude that this is an additional/ new FDA requirement to smooth out or pave the way for the possible EUA?
Can I get your thoughts?
Ann: MSB Annual Financial Results and Operational Progress, page-186
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