For those worried about the approval of Remdisivir by the Federal Department of Cronyism today and it imposing on the likelihood for REM-L approval for COVID-19 ARDS...
Bear in mind fromthe study that the FDA will use to justify its approval, (that saw "serious adverse events occurred in 131 of 532 patients (24.6%) in the remdesivir group") had 11.4% of those treated who were still dead at 29 days (15.2% in palcebo cohort). Of those the majority were inevitably from ARS:
"There were 47 serious respiratory failure adverse events in the remdesivir group (8.8% of patients), including acute respiratory failure and the need for endotracheal intubation"
The incidence of ARDS among non-survivors of COVID-19 is being reported as 90% outside of this study:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7441837/
Remdisivir clearly has very questionable results. There is still a huge unmet need for ARDS related COVID-19 deaths which form the vast majority of deaths.
Its my personal belief that new strains of COIVD-19 are less likely to kill their hosts, which is a great thing for humanity, but for our purposes doesn't change a thing. Vast swathes of people are still dying from COVID-19 and the majority of those deaths involve ARDS, which traditional standards of care, including corticosteroids and antivirals, are making little impression on. The FDA is not stupid and knows this. If REM-L is efficacious in the trial they will have no choice but to approve with an unmet need in the worse pandemic since Spainish Flu.
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- Ann: Phase 3 Trial in COVID-19 ARDS Surpasses 50% Enrollment
Ann: Phase 3 Trial in COVID-19 ARDS Surpasses 50% Enrollment, page-335
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