NeuroRx chief lines up Hail Mary for once-rejected Covid-19 drug
NeuroRx’s Covid-19 treatment was already shot down by the FDA once, and it failed the primary endpoint in a Phase IIb/III readout — but that won’t stop CEO Jonathan Javitt from lining up a Hail Mary pass to regulators.
Javitt gave Endpoints News a preview of Phase IIb/III data based on an initial 28-day endpoint on Monday afternoon. At 28 days, critically ill Covid-19 patients given NeuroRx and Relief Therapeutics’ aviptadil were 35% more likely to recover and be discharged from the hospital compared to those on a placebo, Javitt said. However, the p-value was 0.08 — falling well below the 0.05 p-value needed to demonstrate statistical significance, meaning there’s a greater chance that the results were random and not tied to the treatment.
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