Clinical Improvement in Covid Remdesivir Double Blind Study Is Not Statistically Significant.

[NNadir]

18. And that is the reason, the FDA always assembles a committee of scientists to review the data.

Many drugs are approved on split recommendations. Ultimately however, there are many unknowns and many tradeoffs.

I participated in the development of a drug in the 1990's that treated recalcitrant high blood pressure that was highly observed in people of African American descent. (Omapatrilat) It was expected to be a blockbuster and went all the way through phase III clinical trials. It was abandoned because of a subset of subjects developed angioedema that risked closing their airways.

I always wondered if more people died from strokes from not having blood pressure control than would have died from angioedema. (There were no deaths, but there were statistically significant close calls if I recall correctly.)

The drug might be approvable today if a biomarker for the angioedema side effect could have been identified, i.e. in a "personalized medicine" setting.