I feel like I'm having to be Debbie Downer these d
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Posted On: 03/02/2021 2:48:46 PM
I feel like I'm having to be Debbie Downer these days.
We wont be receiving approval for all three at the same time. Assuming EUA for Severe Critical, the FDA will want us to enroll and complete a Phase 3 for Mild to Moderate, as well as for Longhaulers.
The good news is that the Longhauler trial will enroll quickly. The bad news is that it will take3-4 months to complete the trial (56 days) and submit the data to the FDA. (30-60 days)
M2M I believe would enroll fairly quickly (not as quickly), but should have a shorter follow up period.
This puts us into late Summer for phase 2 Long haulers and Phase 3 M2M.
It is possible that the FDA would allow Phase 2 data in conjunction with our CD12 data, but I dont think we should expect it. If they do allow, then M2M could be sooner than Long Haulers.
We wont be receiving approval for all three at the same time. Assuming EUA for Severe Critical, the FDA will want us to enroll and complete a Phase 3 for Mild to Moderate, as well as for Longhaulers.
The good news is that the Longhauler trial will enroll quickly. The bad news is that it will take3-4 months to complete the trial (56 days) and submit the data to the FDA. (30-60 days)
M2M I believe would enroll fairly quickly (not as quickly), but should have a shorter follow up period.
This puts us into late Summer for phase 2 Long haulers and Phase 3 M2M.
It is possible that the FDA would allow Phase 2 data in conjunction with our CD12 data, but I dont think we should expect it. If they do allow, then M2M could be sooner than Long Haulers.
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