Let's look at this sample scenario. Patient A gets

Quote:

---

Let's look at this sample scenario. Patient A gets LL and recovers in 3 days and discharged after 1 week. Patient B is severe and gets placebo but progresses to critical and dies at day 30. Now if you looked only at the stats you will see that LL and placebo were the same, both patients survived past 28 days

---

I understand the scenario. And you may be correct. But this would require that the placebo arm is less than 30% mortality inside of 28 days. You and others have postulated that the SOC has improved enough that this is possible.

Yet, there is zero data to support this. In fact, there are numerous comparable studies, over similar timeframes, showing mortality from 30-35%. Do you have examples of data sets showing the placebo mortality less than 30%?

With that said, I do agree with you and others that if what you fear is true (we barely missed PE inside of 28 days, yet hit it inside of 42 days) we will no doubt still receive an EUA.

Some are trying to construe this as a potential threat to the issuance of an EUA. I would be pretty surprised if they didnt issue EUA in this "worst case" scenario.