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Re: NamesJeb post# 13085

Thursday, 12/17/2020 8:59:07 AM

Thursday, December 17, 2020 8:59:07 AM

Post# of 16706
The objective of the Phase 2b part of the trial is to investigate multiple endpoints and identify those that show the best efficacy. This was anticipated and was accounted for by the WHO clinical trial guidelines.

^CM explained this point in the last proactive interview

Additionally, after the Company finalized its investigational new drug application (IND), the U.S. FDA (FDA), updated its guidance on COVID-19 clinical trials stating a preference for a respiratory failure-based endpoint as an alternative to the WHO score as the primary efficacy endpoint for the Phase 3 portion of the trial.

^Also explained in the last Proactive video

Finally, due to the complexity of clinical trials, one endpoint can show efficacy while other endpoints do not. For example, in Algernon’s interim data, by day 15, there was a trend towards fewer patients requiring mechanical ventilation in the high dose Ifenprodil treatment arm, as compared to patients who were in the untreated arm of the study, even though all patients had similar mean WHO and NEWS scores.

^This point was clearly stated in the interim data report.

My Biggest concern here is why should a company need to send out a news release explaining /clarifying it's last news release? Doesn't seem very professional.

B. O. B.