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Originally Posted by TLO
So how long do we have to wait to get approval if Remdesivir works? It's not a new drug, so couldn't it be approved fairly quickly?
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You'd get increased rollout through compassionate exemptions fairly quickly, and broader approval in maybe 4-6 months, but that's a very rough guess based upon past history and other previously untreatable epidemics (AIDS). The closest analogue is probably AZT, which was approved in 1987, in record time (6 months). However, early doses were far too high and people who took it often suffered substantial side effects (cytopenias, mostly) from such large doses.
You'd need large urban or academic centers in most cases. Quick, accurate testing (without the substantially high false positive rates of the original tests), likely confirmed by CT, which appears to be the gold standard at this point.
Since there aren't other standards of care, you could treat against placebo, then see how patients did in comparison, but remember that in a disease with a small case fatality rate, marginal decreases would lead to statistically significant declines based upon how you interpret the data.
Here's an example: 1000 people get coronavirus and 970 live without remdisivir. 1000 people get coronavirus and 990 live with it. What's my relative risk reduction?
My event rate (death) is 3% in the control group and 1% in the experimental group. My absolute risk reduction is only 2%, but my relative risk reduction is (0.03-0.01)/(/0.03) is 66.7%, which means that I've reduced my risk of death by 2/3. Now, how many people do I need to treat to avoid 1 death? In that case, I take 1/absolute risk reduction, which is 1/(0.02), which is 50. Thus, for every 50 patients I treat with remdisivir, I prevent one excess fatality. That's pretty good from a pharmacoeconomic standpoint, but if you're treating millions of people, that's going to be a substantial financial outlay.