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Sorry, but Remdesivir is not an FDA approved drug. The article itself states: Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use.
Yes, you are correct, it is not yet FDA approved. Nevertheless, these are Phase III trials and the FDA stands ready to fast-track this if the results are good.
Update:
Now I know why I was confused. It did have 'Orphan Drug' status, but gave that up for business reasons I guess. Still, it shows the FDA is ready to go on this if the results are good:
Will this be a game changer? None of us can know right now, one way or another.
But this, and all other drug therapies, will be objectively evaluated by professionals who understand what they are doing, unlike the internet rumors that have excited some.
So, although I am in the dark on this, I know that there are people working on this who are not. My only comments on the merits -- and my comments are of very limited value -- are that it is in Phase 3, which means that the professionals are fine with the criteria of phases 1 (safety) and 2 (efficacy), and are evaluating for the phase 3 criteria (efficiency -- don't ask me how "efficiency" is different from "efficacy," but I assume that they know .)
Given that, FDA can expedite approval, depending on the results.
So, would an approved drug treatment be a game changer? Yes, but not as big a changer as a vaccine. But now there is no treatment at all, except to use ventilators to help the patients breathe if they develop pneumonia -- which means, it is up to your body to recover, and doctors can help a little if you are at the extreme level that is near death due to respiratory failure, but that's all, and it often doesn't work. A drug treatment that makes it a treatable disease, reduces death rates and gets patients out of the hospital sooner would alter the game in a huge way.
It would not solve the problem, nor make everything safe, nor restore normality, but it would reduce the impact considerably, and if it turns out that having the virus conveys any immunity (which is not yet certain, but it is thought to be likely) then the ability for people to get well after getting the illness will in fact change things profoundly, as the number of immune ex-patients will rise quickly and blunt the spread of the virus to new people.
Again, I don't know, but the professionals will, and they will do the job that needs to be done to answer the questions. Personally, I am hopeful, but my hope won't change anything. It's up to science, and it always was.
One thing I am sure of is that all these medical and scientific questions have to get out of the hands of political people and partisans of one sort or another, and into the hands of medical and scientific people who deal with facts, not political power or self-interest or winning. It's a big mistake to make every question a political question, which quite a few people basically have done, to their own eventual detriment as well as everyone else's. (Short rant, now over. )
So my non-ranting comment is that I hope this works, and we will have to wait until we know.
Bob.
When one door closes, another opens.
-- Cervantes, Don Quixote
This is extremely interesting, but they used a "slightly damp washcloth" rather than a mask, which slightly disappointed me -- the reason being that (a) your mask probably won't be slightly damp in the same way that the washcloth was, and (b) I think it is likely that the water on the washcloth would capture the wet droplets more efficiently than a dry material.
Even so, it does say something about not exposing other people to the output of your unfiltered speech, and about the need for masking in public to slow the spread of the disease.
Bob.
When one door closes, another opens.
-- Cervantes, Don Quixote
That's true but you should expect that more than 1 Phase III trial should be needed. If there's one thing bio or pharma companies like to do it is to report that study results look promising. Truth is that it's much more complex. For example, you can have 90 out of a 100 patients recovering but if only 1 of them dies unexpectedly, the results are still good yet it might take many months to investigate the reason for the lost live and that will hinder study completion. I've lived and breathed in the pharma world for a very long time and I've seen the most promising clinical trials go bust.
Again, all good news, but you said game changer and I think we're far from. This is more likely to be a seasonal thing that'll come back every now and then and it might well be that the 6 feet world is here to stay for a while and that we'll move between localized outbreaks and local shelter-at-home measures until there's a more permanent solution...
To be fair (and may be semantics) but there was a question mark after "game changer"
Hopefully a useful solution will turn up soon for people in need. Until then, we know what we have to do to keep this thing at bay and slow it from spreading further.
My daughters best friend is a Doctor in Washington State working the Corona intensive care wards. The anecdotal info is maybe 1 in 6 are unhooked from a respirator to go home, 5 in 6 are put in bags. If this drug changes the equation it makes it much much easier for governors to open things back up.
16:45
"It's not dangerous according to a doctor in La who prescribes it for 2,000 patients suffering from Lupus and rheumatoid arthritis " for 6 days "the risk is nil"