4 ms·
> So an abbreviated trial in 775 people is considered sufficient to move forward with drug approval now? No. They don't have full approval, and aren't likely t
by SideburnsOfDoom 5y ago
> So an abbreviated trial in 775 people is considered sufficient to move forward with drug approval now?
No. They don't have full approval, and aren't likely to get it in the next few months.
From the article:
> Merck Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible
Emergency Use Authorization is not full approval, and obviously comes with oversight and data gathering. "as soon as Possible" is not now. But they might get that in the next few months.
Other than that, I don't know what to say about "sufficient to move forward" - any drug at any stage of trials is either abandoned or moving forward? A small trial that meets its goals is sufficient to move forward to the next trial so .. yes? But not to full approval, which they aren't getting anyway.
This is an existing (but fairly new) drug so there there is other data on safety etc, links seem to be about 2019 onwards, at https://en.wikipedia.org/wiki/Molnupiravir https://en.wikipedia.org/wiki/Molnupiravir
- AndrewBissell 5y agoWas using "approval" colloquially, I understand the distinction between that and "authorized." However I have seen many larger trials for other repurposed drugs being tried in early treatment dumped on as "underpowered" so it's just odd that that criticism is nowhere to be found in this case. There were 7 people hospitalized in the trial group and 14 in the placebo.
- loeg 5y agoThe criticism is not present because this one wasn't underpowered. > p=0.0012