Quote:(Bird chirping). No one can answer that question.
It's pretty simple. They need to prove EFFICACY & SAFETY. Everyone seems to ignore the fact that many, many people are recovering on their own. That's much less the case once you are on a respirator where the death rate is as high as 80%.
But the fact remains, you need to show STATISTICAL RELEVANCE that exceeds the chance people are just improving on their own. It's the same with Hydroxychloroquine. You need to test in a controlled fashion.
All these people whining about patients in a severe condition being allowed to die because they're in the placebo arm is pure hogwash. There are procedures in place to unblind and move to the control group if necessary.
You should all be ecstatic that the FDA wants proof. Otherwise, there would be a lot of drugs/treatments out there, unproven and detracting from leronlimab's results. It's an extremely short trial and interim analysis is even shorter.
What you really should be concerned about is the company sourcing funds to support a huge spike in expenses and it's about to get much, much worse. I hope a govt grant is provided. But I think it's a very small chance. If there were ever a case for it, this would be it.
Now, what happened to the emergency FDA approval that NP was brandishing last week?
