It would probably be difficult to show efficacy in a range
It would probably be difficult to show efficacy in a range of respiratory diseases. Severe covid was difficult enough and those patients were in mortal danger so there was a binary outcome. For less severe illness the outcomes aren't so well defined and the FDA is likely not going to accept an improvement in biomarkers as a primary endpoint for a respiratory disease.
The other main indication for alleviating the cytokine storm I've seen is associated with CAR-T therapy. That was the focus of Humanigen's drug before covid and is again their main objective. But there's the chance that market could diminish somewhat with the next gen CAR-T therapies not causing as serious immune system issues.
Cyrus said he is looking for unequivocal efficacy data so it's important to have trial objectives as focused as possible.
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