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Re: Inelgr post# 35938

Tuesday, 02/23/2021 3:55:36 PM

Tuesday, February 23, 2021 3:55:36 PM

Post# of 44695

"Don't put too much stock (no pun intended) into the 28 day mortality marker."



More on this from today's PR:

"The clinical trial was originally approved as a 28-day study at FDA's direction. In December, NeuroRx added a 60-day endpoint based on the recognition that the traditional 28-day endpoint adopted in the 1990s for trials in Acute Respiratory Distress Syndrome is not appropriate for critically ill patients with Covid-19, who are frequently maintained in the ICU with advanced technologies well beyond this time point. NeuroRx and other clinical trial sponsors alerted FDA to this trend and yesterday the FDA published formal guidance† changing the required time for measuring the prespecified endpoint of "alive and free of respiratory failure" in critically ill patients to 60 days. "



https://www.prnewswire.com/news-releases/neurorx-announces-that-zyesami-aviptadil-has-successfully-demonstrated-10-day-accelerated-recovery-from-respiratory-failure-in-critically-ill-patients-with-covid-19-treated-with-high-flow-nasal-oxygen-at-28-day-interim-endpoint-301233805.html



Earlier: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=161750475

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=161751085

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=161753324