I don't believe for one moment that Lalezari said
Post# of 155062
(Total Views: 705)
Posted On: 01/03/2021 12:41:26 AM
Re: MD VIROLOGIST #70979
I don't believe for one moment that Lalezari said that.
Lalezari is nothing except a thoughtful patient advocate. Nothing except that.
While Lalezari has always been promotional in his exposition of the benefits of leronlimab, he also has been circumspect in his claims that leronlimab would work for certain.
What Lalezari knows for certain is that there are some covid patients who are tremendously helped by leronlimab. He knows that for certain.
What Lalezari also knows for certain is that the primary mortality endpoint could be missed. Its a small study. Covid treatment is all over the map for the duration of this study. Its very, very poorly controlled due to all of the various things being tried in all of the CD12 patients.
Lalezari knows that if CD12 misses the primary endpoint mathematics, it is because the trial has too few participants to tease out the subpopulation of patients in which LL is highly effective.
Lalezari knows that a 20% mortality reduction is still tremendously valuable even if it missed the endpoint mathematics.
Lalezari knows that if the primary endpoint math is a miss, there will still be a discussion to approve.
Lalezari knows that alienating the FDA with "blood on your hands" comments will only make that discussion more difficult.
Lalezari was no doubt aggressive in demanding fda approval, but no way it happened like that. That description of the meeting is incomplete.
Lalezari is nothing except a thoughtful patient advocate. Nothing except that.
While Lalezari has always been promotional in his exposition of the benefits of leronlimab, he also has been circumspect in his claims that leronlimab would work for certain.
What Lalezari knows for certain is that there are some covid patients who are tremendously helped by leronlimab. He knows that for certain.
What Lalezari also knows for certain is that the primary mortality endpoint could be missed. Its a small study. Covid treatment is all over the map for the duration of this study. Its very, very poorly controlled due to all of the various things being tried in all of the CD12 patients.
Lalezari knows that if CD12 misses the primary endpoint mathematics, it is because the trial has too few participants to tease out the subpopulation of patients in which LL is highly effective.
Lalezari knows that a 20% mortality reduction is still tremendously valuable even if it missed the endpoint mathematics.
Lalezari knows that if the primary endpoint math is a miss, there will still be a discussion to approve.
Lalezari knows that alienating the FDA with "blood on your hands" comments will only make that discussion more difficult.
Lalezari was no doubt aggressive in demanding fda approval, but no way it happened like that. That description of the meeting is incomplete.
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