I think the FDA is waiting to see Phase 2 M2M data before making a decision of when to look at Phase 3 data. If it's good or better, they perform interim analysis right away, which will provide them with a number bigger than 50 to make a decision. They can then more confidently ("rolls eyes" ) make the call to issue an Emergency Use Approval with a n > 50. Especially since they know we have 120 enrolled.
This is the difference of 1-3 weeks maybe. It's unfortunate because more people will die who could have potentially been saved. However, it also provides greater assurance that the true power of Leronlimab will be displayed in the P3 interim data.
Makes sense, do it right (your idea of "right" may vary from the FDA's), do it the first time. I believe the FDA is on our side, just not our timeline. They work in a super conservative manner with their blinders on to outside noise aka non-placebo controlled data.
I have also come to think that once this is all said and done, and Leronlimab saves many people from several grievous illnesses, that there will be a look back into why this was not given to the world sooner. Or one can at least hope.
I've waited for news and updates for almost 2 years at this point, now more anxiously than ever. But what's another few weeks. Long and Strong.
This is the difference of 1-3 weeks maybe. It's unfortunate because more people will die who could have potentially been saved. However, it also provides greater assurance that the true power of Leronlimab will be displayed in the P3 interim data.
Makes sense, do it right (your idea of "right" may vary from the FDA's), do it the first time. I believe the FDA is on our side, just not our timeline. They work in a super conservative manner with their blinders on to outside noise aka non-placebo controlled data.
I have also come to think that once this is all said and done, and Leronlimab saves many people from several grievous illnesses, that there will be a look back into why this was not given to the world sooner. Or one can at least hope.
I've waited for news and updates for almost 2 years at this point, now more anxiously than ever. But what's another few weeks. Long and Strong.
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