It’s too bad that the interview got off on the w
Post# of 155052
(Total Views: 619)
Posted On: 07/09/2020 4:25:30 PM
It’s too bad that the interview got off on the wrong foot. From NP’s initial comments, he seemed upset that as he thought the (live) session was to have started 30 minutes earlier. He lashed out about the late start and that it would curtail the interview. The blithering interviewer, Jack, mumbled that it was 1:30 and on-time. NP never really recovered from that. NP could not hear the questioner who could barely pronounce any of the words! So it went from bad to worse.
The only thing I learned new was that there was an additional option, besides the 51 patients interim analysis milestone, for the severe to critical trial where Cytodyn could request a “safety board” review of the results up-to that point. I guess that board is convened and privately unblinds the data and looks at the relative safety performance of the patients in the two arms of the trial. Clearly, if the Lironlimab arm is saving lives/improving the course of the disease significantly while the placebo arm is suffering and perhaps having a statistically higher death rate, then this board could stop the trial and allow for Lironlimab to be administered to the placebo patients immediately.
It sounded to me like this is under consideration, in conjunction with the mm trial results.
The only thing I learned new was that there was an additional option, besides the 51 patients interim analysis milestone, for the severe to critical trial where Cytodyn could request a “safety board” review of the results up-to that point. I guess that board is convened and privately unblinds the data and looks at the relative safety performance of the patients in the two arms of the trial. Clearly, if the Lironlimab arm is saving lives/improving the course of the disease significantly while the placebo arm is suffering and perhaps having a statistically higher death rate, then this board could stop the trial and allow for Lironlimab to be administered to the placebo patients immediately.
It sounded to me like this is under consideration, in conjunction with the mm trial results.
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