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Posted On: 03/06/2021 12:31:07 PM
Post# of 148908
Re: nmbr1stckpckr #81273
EIND only occur at sites that are not part of the trial. They are not competing.
They shoudl be able to enroll fairly quickly, but if we do in fact need this additional data set for a US EUA, it will be months, as the trials take time to complete and review.
We dont yet know if this is tied to EUA or full approval. Not to mention that there are other countries in the fold.
This does feel like a set back, but we dont have all of the info. And as others have pointed out the EUA does not require statistical significance.
While I agree that 62 patients is not enough power, I also believe that if we look at the data across all categories there may be enough to see that there is clearly a positive effect.
Remember that the requirement for an EUA is "does the potential benefit outweigh the potential risk."
With that said, the fact that we are a small start up does not help our cause. We dont know how this is going to play out.
They shoudl be able to enroll fairly quickly, but if we do in fact need this additional data set for a US EUA, it will be months, as the trials take time to complete and review.
We dont yet know if this is tied to EUA or full approval. Not to mention that there are other countries in the fold.
This does feel like a set back, but we dont have all of the info. And as others have pointed out the EUA does not require statistical significance.
While I agree that 62 patients is not enough power, I also believe that if we look at the data across all categories there may be enough to see that there is clearly a positive effect.
Remember that the requirement for an EUA is "does the potential benefit outweigh the potential risk."
With that said, the fact that we are a small start up does not help our cause. We dont know how this is going to play out.
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