Correct me if I'm wrong, but isn't the primary end
Post# of 154233
(Total Views: 628)
Posted On: 07/06/2020 2:29:04 PM
Correct me if I'm wrong, but isn't the primary endpoint for m2m trials how many of the drugged group move on to become severe/critical? If leronlimab's MOA is as advertised and works as Dr. P has explained (and confirmed with data), then the expected result should be that at least 2/3 of the patients did not progress to s/c (and are either still in the hospital recovering or have gotten better and went home).
If all or most of the placebo progressed to s/c, then it would be obvious that leronlimab is effective. If all or most of the placebo instead got better, then I'd say FDA will require a ph3 trial. So I feel guilty in stating that I hope the former for the placebo group. But I also hope they got moved into the s/c trial and received leronlimab then.
But I digressed. My point was that there is a strong possibility that the government will tout leronlimab as a theraputic later this week since the end point for the m2m trial should be quick and easily deciphered from the data. Almost anecdotal except with an unidentified placebo group.
If all or most of the placebo progressed to s/c, then it would be obvious that leronlimab is effective. If all or most of the placebo instead got better, then I'd say FDA will require a ph3 trial. So I feel guilty in stating that I hope the former for the placebo group. But I also hope they got moved into the s/c trial and received leronlimab then.
But I digressed. My point was that there is a strong possibility that the government will tout leronlimab as a theraputic later this week since the end point for the m2m trial should be quick and easily deciphered from the data. Almost anecdotal except with an unidentified placebo group.
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