(Total Views: 615)
Posted On: 08/23/2020 7:58:08 PM
Post# of 153988
“Exactly, that is the goal , prevent worsening , so our M/M study did the same... We should have EUA now....”
I don’t disagree that leronlimab is likely to prevent patients from progressing to severe/critical, but I don’t know if the M2M trial proved that enough for an EUA to be approved for that purpose. Is the statically significant reduction in NEWS 2 enough to convince the FDA that the drug will reduce hospitalizations and mortality in severe/critical patients or in patients who could progress to that? We can see from the HIV BLA that the FDA is picky.
We also don’t know the demographic of the patients enrolled in the M2M trial (age, comorbidities, etc)., so at this point, the majority of those enrolled could’ve been under 50 years old with minimal comorbidities.
I don’t disagree that leronlimab is likely to prevent patients from progressing to severe/critical, but I don’t know if the M2M trial proved that enough for an EUA to be approved for that purpose. Is the statically significant reduction in NEWS 2 enough to convince the FDA that the drug will reduce hospitalizations and mortality in severe/critical patients or in patients who could progress to that? We can see from the HIV BLA that the FDA is picky.
We also don’t know the demographic of the patients enrolled in the M2M trial (age, comorbidities, etc)., so at this point, the majority of those enrolled could’ve been under 50 years old with minimal comorbidities.
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