$RLFTF whoknows on Yh0 Still in the newest S-4 ,
Post# of 653
(Total Views: 382)
Posted On: 05/19/2021 5:53:22 PM
$RLFTF whoknows on Yh0 Still in the newest S-4 , on numbered page 190 .....
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"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."
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have a good day , stay safe !
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http://filings.irdirect.net/data/1719406/0001...37ds4a.pdf
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"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."
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have a good day , stay safe !
.
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http://filings.irdirect.net/data/1719406/0001...37ds4a.pdf
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