You make a strong argument. However, it assumes:
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Posted On: 07/15/2020 10:08:14 AM
You make a strong argument. However, it assumes:
A) that we may get COVID approval based on the PH2 M2M trial (I think this is a long shot)
that the FDA will follow it's typical timeframes.
It's entirely possible that they are given the data quickly, and use it in their analysis of COVID.
We don't know how this is going to play out, but my guess is that the M2M data will be strong, but we will be asked for more. And we will resume enrollment of the M2M for Ph3. Pressure will build, they will do an interim analysis of severe at 195 and will stop the trial. I believe they will then do an interim of Ph3 M2M and stop it as well.
I desperately want them to give us a EUA, but I think we should entertain the idea that this may take a little longer. I hope that I am wrong.
A) that we may get COVID approval based on the PH2 M2M trial (I think this is a long shot)
that the FDA will follow it's typical timeframes. It's entirely possible that they are given the data quickly, and use it in their analysis of COVID.
We don't know how this is going to play out, but my guess is that the M2M data will be strong, but we will be asked for more. And we will resume enrollment of the M2M for Ph3. Pressure will build, they will do an interim analysis of severe at 195 and will stop the trial. I believe they will then do an interim of Ph3 M2M and stop it as well.
I desperately want them to give us a EUA, but I think we should entertain the idea that this may take a little longer. I hope that I am wrong.
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