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Re: None

Thursday, 06/18/2020 1:00:59 PM

Thursday, June 18, 2020 1:00:59 PM

Post# of 44382
I think the spark that ignites HGEN will be the interim analysis. From the Phase III clinical trial of Lenzilumab summary:

"238 patients will be randomized to receive lenzilumab + SOC vs. SOC in a 1:1 ratio. An interim analysis is planned for DSMB to assess safety & efficacy data."

When will that interim analysis be done? There is a possibility that the trial is ended at that point because efficacy and safety is already confirmed. We are in the middle of a massive global emergency, and all effective treatments must be fast-tracked.

Anybody know whether HGEN has given an indication of when the interim analysis will be done? They are recruiting at 8 sites (3 Mayos, Dartmouth-Hitchcock, Emory, etc.) so recruitment should be pretty fast.

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