“I think the reason the LH protocol is taking so
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Posted On: 11/12/2020 8:30:44 PM
“I think the reason the LH protocol is taking so long is that they want to carefully select the right PE so that it can be hit with stat sig in phase 2, thereby not needing phase 3.”
IMO, regardless of the statistical significance of the phase 2 trial, a larger phase 3 will be needed. The trial size is small and unlikely to satisfy FDA requirements for an approval. Our M2M trial would’ve required a larger phase 3 if the primary endpoint has been met. I’m sure some will mention EUA, but I’m not sure if longhaulers is a disease that meets that criteria.
IMO, regardless of the statistical significance of the phase 2 trial, a larger phase 3 will be needed. The trial size is small and unlikely to satisfy FDA requirements for an approval. Our M2M trial would’ve required a larger phase 3 if the primary endpoint has been met. I’m sure some will mention EUA, but I’m not sure if longhaulers is a disease that meets that criteria.
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