Saturday, April 23, 2022 11:08:44 AM
It is your OPINION that it doesn’t say what I think it says. PROVE me wrong…you can’t.
I have seen the back and forth that occurs between company and FDA when it comes to finalizing the exact analysis & output with a standard design trial, and the queries and detailed responses & adjustments in procedure that transpire AFTER the SAP has been filed and the database is locked. Establishing the exact capture procedure and validation of the Hybrid/ECA did not necessarily occur before data lock. Anyone outside the NWBO organization or FDA that says they know what happened and when it occurred is LYING. It is all speculation. Those discussions are highly confidential.
I have grown tired of YOU and your attitude towards others. I rescind my well wishes. I am neutral on you, meaning I could care less where you stand when the chips down are the cards are played.
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