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PennyWorld

01/10/21 11:53 AM

#33540 RE: Clarnold #33539

Great Question!
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J-Belfort

01/10/21 12:05 PM

#33541 RE: Clarnold #33539

We filed for an EUA based off EAP patient data, were not denied but rather informed the FDA would like additional data. Specifically, the results from the randomized controlled trial. The EUA could be granted immediately upon FDA review of this additional data, there is no "reapplication" etc since we were not denied.

Best,
JB