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Posted On: 02/14/2021 12:32:36 PM
Post# of 148908
Open Label Tests - endpoint??
Dec 24th PR said that Cytodyn had submitted their proposed protocol to the FDA. In it it said the OL tests would conclude upon CD-12 results being unblinded.
Dec 30th PR said that FDA granted Cytodyn their OL protocol with some eligibility criteria changes and changed the conclusion of the trial from the unblinding of CD-12 milestone to a notice from the FDA/Cytodyn.
Seems like the FDA wants to have the flexibility to study the unblinded data without any public knowledge of when the unblinding occurred and also to have freedom to continue collecting important data?
Dec 24th PR said that Cytodyn had submitted their proposed protocol to the FDA. In it it said the OL tests would conclude upon CD-12 results being unblinded.
Dec 30th PR said that FDA granted Cytodyn their OL protocol with some eligibility criteria changes and changed the conclusion of the trial from the unblinding of CD-12 milestone to a notice from the FDA/Cytodyn.
Seems like the FDA wants to have the flexibility to study the unblinded data without any public knowledge of when the unblinding occurred and also to have freedom to continue collecting important data?
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