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Thursday, 12/24/2020 7:15:18 PM

Thursday, December 24, 2020 7:15:18 PM

Post# of 44325
I wonder if the only thing needed to complete our 75% interim analysis is a calendar.

The company projected that we would need 390 patients for the 75% review.

"The next interim analysis for efficacy is planned when the study reaches 75 percent events (302 events) which will require approximately 390 patients to be enrolled in the trial."

https://www.humanigen.com/press/Humanigen-Announces-Positive-Interim-Phase-3-Data-of-Lenzilumab%E2%84%A2-in-Patients-Hospitalized-with-COVID-19

To date, we have 445 patients enrolled.

Slide 5

https://9e234b13-0cc4-4c74-b924-d7874342289e.filesusr.com/ugd/6ca631_3caabbbd998242d983e4e21b88bbd85f.pdf

If we have maintained the 5 day time to recovery and discharge as observed in the Mayo Clinic study, those 390 required patients are probably at home now enjoying Christmas with their families. There's likely a good chance that the clinical data has all (or mostly all) been reviewed by the DSMB by now also. All that is left is to see if the Hazard Ratio will stay above 1.29 on the 28th day after diagnosis.

I'll bet that this is the catalyst that has propelled our share price upward.

I think this is enough data to submit for an EUA approval. The race is on.



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