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The number of patients fully treated, at that poin

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Post# of 155494
(Total Views: 588)
Posted On: 07/05/2020 11:22:58 AM
Posted By: blafarm
Re: Babaji #41060
Quote:
The number of patients fully treated, at that point, will be greater than 120 but the data compiling and analysis will be trivial as the endpoints are mortality counts only. Hence NP’s statement we will submit data from both trials simultaneously to the FDA makes sense to me.

I would hope there will be 120 at that point, but I'm not sure.

I believe Dr.NP indicated there were 127 patients enrolled in the P3 S/C as of yesterday (July 4). However, we don't know if all have been injected, and those who are injected must participate for 28 days.

As Dr.NP indicated, the results of the P2 M/M would be available (presented to the FDA?) in the month of July. We don't know if he means in two weeks -- or on July 31.

Not trying to be argumentative, but we can't really know for sure how many fully completed P3 S/C patients we'll have at that time, especially since I imagine there would be some amount of data processing time that would need to be added to that 28 day window.

I agree that we all hope the number will be large enough.


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