So an abbreviated trial in 775 people is considered sufficient to move forward with drug approval now?
> The MOVe-OUT trial (MK-4482-002) (NCT04575597) was a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study [...]
If you go to https://ivmmeta.com/ you will see:
* Most of the studies have not placebo, they just compare a group of people with another unrelated group of people. It's very difficult to be sure there are no unexpected differences.
* If you filter only the RCT, most of them are not statistically significant. That is a problem because if the drug has no effect, the reporting/publishing/selection bias will cause barely significant studies to accumulate.
* There are only 6 that RCT that are statistically significant. Have you read them? Some have very weird things that are very big red flags.
If Ivermectin has no effect, I expect like 2 of the RCT that are statistically significant to be caused by flukes. Can you pick your favorite 3?
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
> p=0.0012
I'll don my tinfoil hat for a moment. A combination of initial vaccine effectiveness estimates having to be downgraded, and variants reducing effectiveness further, along with the infectiousness data of vaccinated carriers putting the herd immunity targets at risk have public health authorities scrambling for the next potential solution.
The data out of Israel and other places is damning. Not in the sense that anti-vaxxers would like, but in the sense that we are still nowhere near containing this thing.
We either need better vaccines, or drugs. So yes, epidemiological standards will relax in the face of a worldwide pandemic, to some extent.