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Friday, November 20, 2020 9:54:50 AM
Michael Taylor: this might be the Quarter they report the P3 Multikine study that Reached the Required Number of Events IN MAY. (and I still wager that they will switch the Pbo group to historical control in the name of Covid) Which means, the study flat out failed, years ago.
Geert: This is drug development. There are rules despite what you say. Look at FDA guidance and you will see that FDA wants to see ALL comparisons (e.g. study control, SEER and historical) plus have the electronic data base so that they can analyze the study in any way they desire.
MK trial has a control arm, why do FDA want to see SEER and historical
comparisons? Does it mean the primary endpoint is not SS? To me, this
is a clear sign CVM is data mining now and CVM is doing exactly the same
thing NWBO is doing, interesting Geert did not defend CVM against Micheal's
comment of "the study flat out failed".
Recent CVM News
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