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Posted On: 08/19/2020 10:40:06 PM
Post# of 155808
Convalescent plasma, in the one published double blinded study showed improvement with p=0.26.
Leronlimab succeeded with p=0.02. That is a robust result, more than a magnitude of order better than convalescent plasma.
Continued studies of plasma, especially as appropriate timing of administration is uncertain, are appropriate. Blanket approval in advance or demonstrate efficacy is not appropriate.
The whole of the data on convalescent plasma is intriguing, but ambiguous. Is it effective once disease has progressed to immunologic phase? So far it appears not, demonstrating as always that a good therapy at the wrong time is contraindicated.
The whole of the data on Leronlimab is unambiguous, demonstrating improvement without increased adverse event, across the whole of the patient populations to which it has been administered.
There was not data mining. NEWS2 was a designated endpoint from trial inception.
No change in endpoints.
No change in trial size.
No addition of trial exclusions.
Leronlimab EUA should be approved. P4 should occur, not because the data was insufficient, but because the ideal dosing regimen and biochemical markers for administration have not been established for what will be an extremely valuable and unfortunately scarce resource.
Leronlimab succeeded with p=0.02. That is a robust result, more than a magnitude of order better than convalescent plasma.
Continued studies of plasma, especially as appropriate timing of administration is uncertain, are appropriate. Blanket approval in advance or demonstrate efficacy is not appropriate.
The whole of the data on convalescent plasma is intriguing, but ambiguous. Is it effective once disease has progressed to immunologic phase? So far it appears not, demonstrating as always that a good therapy at the wrong time is contraindicated.
The whole of the data on Leronlimab is unambiguous, demonstrating improvement without increased adverse event, across the whole of the patient populations to which it has been administered.
There was not data mining. NEWS2 was a designated endpoint from trial inception.
No change in endpoints.
No change in trial size.
No addition of trial exclusions.
Leronlimab EUA should be approved. P4 should occur, not because the data was insufficient, but because the ideal dosing regimen and biochemical markers for administration have not been established for what will be an extremely valuable and unfortunately scarce resource.
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