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Posted On: 11/05/2020 11:02:14 PM
Post# of 148898
Well, I just listened to the webcast again. Nader was emphatic in saying that we are all blinded, and only 1 person has seen the s/c interim data, but then adds another person, then apparently, a 3rd person. My confusion is that he did not emphasize, what would be very significant, if the FDA had inf fact, requested and obtained the s/s interim 195 data (for what purpose other than to look for the purpose of maybe granting some type of access to leronlimab). His casual attitude IMO, supports ohm's stating here on IH, that the FDA does not possess the s/s interim 195 data. Either way, I wrote down Nader's exact words as follows: (33 minutes and 34 seconds):
"We are all blinded, everybody is blinded. The only person who is unblinded is the Amerex bio-statistician who is allowed to do the analysis for the DSMC. DSMC also saw the data. And the firewall statistician AT THE FDA also saw the data, that’s it."
Nader says the firewall statisitican is "at the FDA". ohm here on our IH said the firewall statistician does not work for the FDA and the FDA does not have the interim data.
"We are all blinded, everybody is blinded. The only person who is unblinded is the Amerex bio-statistician who is allowed to do the analysis for the DSMC. DSMC also saw the data. And the firewall statistician AT THE FDA also saw the data, that’s it."
Nader says the firewall statisitican is "at the FDA". ohm here on our IH said the firewall statistician does not work for the FDA and the FDA does not have the interim data.
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