It seems it is you who is misrepresenting the ema link.
Key quote: "Although ivermectin is generally well tolerated at doses authorised for other indications, side effects could increase with the much higher doses that would be needed to obtain concentrations of ivermectin in the lungs that are effective against the virus. Toxicity when ivermectin is used at higher than approved doses therefore cannot be excluded."
IE, the dose needed for covid could quite possibly be harmful.
Agreed on missing this facet of their advisory. However, the concentration of ivermectin in the early in vitro study was 35x higher than the plasma concentration reached for the approved ivermectin dose [1] whereas the doses used in ivermectin trials (https://ivmmeta.com) range from 1x to 10x the approved dose daily, with successful results as low as 4x approved dose (1x approved dose daily for 4 days)[2]. So whatever ivermectin is doing, it doesn’t seem to require the concentration that the initial in vitro study required.
You've gone from "no, the EMA didn't really to object" to "here's why their objection is wrong". See how that works?
The thing about Covid is that it isn't "super deadly". It has about a 1% fatality rate. That's terrible for society as a whole when the disease is also extremely infectious. But it means that "I took X and recovered from Covid" isn't the most amazing thing.
"So whatever ivermectin is doing, it doesn’t seem to require the concentration that the initial in vitro study required." Maybe the trial dose does nothing at all and people are recovering like they normally do.
This part of their objection was based on an assumption that doesn’t seem to be as bad as they thought. The trials are controlled to varying degrees of quality.
1) Beware of overdosing, because extrapolating from in-vitro studies will yield dosages that are unsafe.
2) We know the dosage required for Ivermectin for be effective, and it is too high.
The first is fact-based and uncontroversial. The second would be completely unfounded and would contradict earlier parts of the statement, so the reasonable assumption is the first interpretation.
Appeals to authority are problematic to begin with. Appeals to authority that misconstrue the authorities (FDA, EMA, and Merck in this case) are counter-productive.
Yes, this is the key item. In vitro there has been some success but at dosage far higher (double digits) than what the safe dose is, and no in vivo trial has been done at those dosages (and likely never will due to the risks involved).
Key quote: "Although ivermectin is generally well tolerated at doses authorised for other indications, side effects could increase with the much higher doses that would be needed to obtain concentrations of ivermectin in the lungs that are effective against the virus. Toxicity when ivermectin is used at higher than approved doses therefore cannot be excluded."
IE, the dose needed for covid could quite possibly be harmful.