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Tuesday, 11/09/2021 2:06:12 PM

Tuesday, November 09, 2021 2:06:12 PM

Post# of 403064
Per 10Q- The Company has received individual patient Expanded Access (compassionate use) requests for Brilacidin to treat critically ill COVID-19 patients who are not responding to prior therapy. Expanded Access was implemented by the FDA and Congress to address physician applications for access to potentially lifesaving drugs, prior to FDA approval, for patients in their care when available treatment options have failed. Following receipt of such requests, the Company has supplied Brilacidin to relevant hospitals for individual patient use, with the FDA granting the treating physician permission for the emergency administration of Brilacidin.



The Phase 2 COVID-19 clinical trial data as of the date of this Form 10-Q remains blinded to the Company. The Company’s biostatistics vendor is currently engaged in analyzing and computing study data and they are expected to deliver Topline results to the Company during the second week of November, 2021.

Topline results still on for this week.


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