Sunday, September 12, 2021 12:30:20 AM
If Humanigen was granted EUA, NIH would still proceed with ACTIV-5.
Durrant initially planned to get EUA and CMA, distribute lenzilumab in US and UK, then go for BLA with data from ACTIV-5.
Although NIH and FDA are working close together, they still can have opposite ideas. Maybe NIH thought lenzilumab was worth doing more research, while FDA thought they need more data to see if lenzilumab was efficient enough to be on the market.
From the data I saw on P3, the data from ACTIV-5 should be as good as what it was on P3. And yes, I also believe HGEN will def get a granted EUA.
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