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Posted On: 04/12/2021 2:08:17 PM
Post# of 148891
Re: enemyofpluto #86405
Quote: I think the 82% mortality improvement represents all the efficacy numbers they need.
I want a EUA as much as anyone and maybe more than most. Our primary end point has to be proven to get a BLA. There is that possibility to get a EUA in a secondary end point but the chances are very minimal.
What we showed was 82% at 14 days and 24% at 28 days. What happened during those 14 days where wveryrhing Demi usher? That’s what everyone wants to know. That’s why the talk of 4 doses and half life of the drug come in.
We started out great with the 82% stat and if it would of held to 28 days we wouldn’t be having this chat. We would have a EUA and BLA soon. We are still working towards that but as for now. We don’t have what it takes to garner an approval. As much as I hate to say that. That’s the truth. Will we get there? I sure the hell hope so... step back and look at the big picture and realize we need something that’s undeniable in order to receive an EUA. Then we can chat some more on what that might be. Until then we wait and see what happens with our extension or another trial. The FDA isn’t going to come to us and say sorry we didn’t realize that you almost worked at 14 days but we need 28 day or more improvement. They want to see the results at 28 days and most likely 60 days going forward.
Read More: https://investorshangout.com/post/view?id=610...z6rqTqyA1K
I want a EUA as much as anyone and maybe more than most. Our primary end point has to be proven to get a BLA. There is that possibility to get a EUA in a secondary end point but the chances are very minimal.
What we showed was 82% at 14 days and 24% at 28 days. What happened during those 14 days where wveryrhing Demi usher? That’s what everyone wants to know. That’s why the talk of 4 doses and half life of the drug come in.
We started out great with the 82% stat and if it would of held to 28 days we wouldn’t be having this chat. We would have a EUA and BLA soon. We are still working towards that but as for now. We don’t have what it takes to garner an approval. As much as I hate to say that. That’s the truth. Will we get there? I sure the hell hope so... step back and look at the big picture and realize we need something that’s undeniable in order to receive an EUA. Then we can chat some more on what that might be. Until then we wait and see what happens with our extension or another trial. The FDA isn’t going to come to us and say sorry we didn’t realize that you almost worked at 14 days but we need 28 day or more improvement. They want to see the results at 28 days and most likely 60 days going forward.
Read More: https://investorshangout.com/post/view?id=610...z6rqTqyA1K
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