It would probably be difficult to show efficacy in
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Posted On: 12/09/2022 2:06:04 PM
Re: Cassandra X #131167
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.
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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