Tuesday, July 27, 2021 2:38:09 PM
If it was up to me, I would probably stop providing lenz to the NIH for their Activ5 trial.
I would appeal the NIH's finding that there was insufficient evidence for them to specifically recommend lenz as a GM-CSF inhibitor, and that Humanigen was treated unjustly by a collective determination which included inferior GM-CSF inhibitors.
I would dispute the Key Limitations they cited. Our study was powered to meet the evolving endpoint the FDA was recommending. I think the HHS OIG should look into why there were differences in supportive care in our study sites, and whether those differences should have resulted in a decrease of our Hazard Ratio rating.
https://www.covid19treatmentguidelines.nih.gov/about-the-guidelines/table-of-contents/
https://www.covid19treatmentguidelines.nih.gov/tables/table-4b/
The FDA should not be deterred in making a decision to approve an EUA for lenz, just because the Otilimab and Mavrilimumab mAbs collectivley caused the NIH to determine there was insufficient evidence to render a GM-CSF group recommendation.
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