9 ms·
What would be the process for getting this drug approved for use in the US? I wonder if it would qualify for the EUA pathway, on the grounds that it's possible
by gnicholas 3y ago
What would be the process for getting this drug approved for use in the US? I wonder if it would qualify for the EUA pathway, on the grounds that it's possible there is a limited window during which it is effective. Has this drug been used for other purposes, which would help regulators know whether it is generally safe? Or would they be assessing it from square one?
- saalweachter 3y agoAccording to the article (and Wikipedia), it's a novel antiviral developed to treat COVID-19, and has reached (or completed, by now?) Phase III trials in Japan, and is currently in use there under an EUA (although I assume the acronym may be different in Japan). If this works for people who have had smell & taste lost for years after recovery, that would imply that the ongoing symptoms were the result of a lingering infection. I'm not sure the referenced study demonstrates that -- as near as I can tell, it was clinically evaluated in people who had new COVID-19 infections.
- gnicholas 3y agoDoes anyone know if it's in trials in the US, or how long the process might take? Just from this thread it seems like there's a decent number of people who have lingering loss of smell, for weeks/months/years after infection.