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From what I remember the FDA was asking Cytodyn to

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Post# of 153802
(Total Views: 531)
Posted On: 01/29/2020 8:30:01 PM
Posted By: TheVexingLegume
Re: sunclouds #16215
From what I remember the FDA was asking Cytodyn to provide a six month stability test for the 700 ml dose back in October of last year. I believe we didn't have stability data for the 700 ml dosage at the time because it seemed that the FDA was going to request the 520 ml dosage for the combination BLA. Cytodyn started the process immediately to prepare a 700 ml test for the FDA but were hoping to get some sort of exemption and only provide them with a few months of stability data. It would seem to me based on Nader's recent remarks regarding the manufacturing submission of the BLA being filed within a few weeks of the clinical that the FDA has agreed to give them a break on the 6 month stability test. Trading, Misiu or Techguru may have better information than I do on the subject if they would like to interject.


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