mc67... and this connects the dots a little further....
PennyWorld Member Level Sunday, 05/16/21 09:50:47 PM
Post # 39518 of 39600
Just another small reminder..... 'end of May' is almost upon us! FDA will then review the data 'promptly'!!
NeuroRx anticipates delivering the detailed efficacy and safety data requested by FDA for an EUA determination by the end of May 2021 in the eCTD electronic format required by FDA and all regulators who are parties to the International Commission on Harmonization (ICH-10). If NeuroRx meets this objective, it will have delivered a regulatory file delineating safety and efficacy data of an investigational drug within 3 months of last visit in a clinical trial. Although there can be no assurance that the FDA will conclude that ZYESAMI meets or exceeds the EUA standard of “may be effective” in the treatment of COVID-19, NeuroRx is hopeful that the FDA will grant EUA to ZYESAMI.
The FDA notified NeuroRx in December 2020 that EUA could only be granted upon submission of randomized, placebo-controlled data and stated that such data would be reviewed “promptly” upon submission.
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