ikool
2021-08-30

$NRX Pharmaceuticals Inc.(NRXP)$

Excerpt from Dr. Jonathan Javitt, 1 hour ago.

@Factchecker.

In response to your concern, nobody has "sliced" any data. Today's report represents data for Respiratory Distress Index across all patients, all baseline severities, and all sites of care. No subgroups or covariates were reported. The prespecified endpoint reported today and submitted to FDA for review is clearly listed on https://clinicaltrials.gov/ct2/show/NCT04311697 under "Other Outcome Measures" and represents a physiologic measure of lung oxygenation, as distinct from the overall primary endpoints (also listed on clinicaltrials.gov) of "alive and free of respiratory failure at 60 days," "Survival at 60 days," and other measures of how patients survive and function. Please refer to FDA guidance for additional insight into the role of physiologic measures, such as Respiratory Distress Index vs. global measures of outcome.

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