Revive Therapeutics Ltd (RVVTF)

[Gatorca]

EUA vs. FDA Approval (From ragstorum reddit)
There’s been some discussion regarding EUA vs. FDA Approval potentially coming out of Revive’s phase 3 clinical trial for bucillamine. EUA is on the table first. Revive has a VERY EXCELLENT shot here.

The FDA has a lot of flexibility on how to extend that authorization. This info from Duke Health gets into EUA vs FDA Approval:

https://www.thefightisinus.org/documents/FDAResearchPlanning.pdf

Emergency Use Authorization – the known and potential benefits outweigh the known and potential risks, including manufacturing purity and reliability.

Emergency use may be authorized for specific populations —such as those at higher risk including healthcare workers—or potentially for a broader population.

EUA offers FDA flexibility regarding approval standards:

(e.g.) For convalescent plasma, FDA authorized emergency use based largely on observational data analysis, and could be augmented/refined through additional observational analysis

(e.g.) For COVID-19 vaccines, FDA plans to issue an EUA only once clinical studies have demonstrated the safety and effectiveness of the vaccine.