Looks as though MHRA/EAM renders decisions on BLS'
Post# of 148181
(Total Views: 645)
Posted On: 10/27/2020 10:05:26 AM
Looks as though MHRA/EAM renders decisions on BLS's within 60 days of notification of acceptance (74 days after Cytodyn submits):
https://clinregs.niaid.nih.gov/country/united..._of_review
"The EC must give its opinion within 60 calendar days of receipt of a valid application. When an EC requires further information before confirming its opinion, it may give a provisional opinion and may make one (1) written request for further information, clarification, or changes to documentation. The time required for the EC to receive a complete response to its request does not count against the 60-day timeline. Certain studies, including gene therapy studies, will take 90 days, or 180 days if a specialist group or committee is consulted."
https://clinregs.niaid.nih.gov/country/united..._of_review
"The EC must give its opinion within 60 calendar days of receipt of a valid application. When an EC requires further information before confirming its opinion, it may give a provisional opinion and may make one (1) written request for further information, clarification, or changes to documentation. The time required for the EC to receive a complete response to its request does not count against the 60-day timeline. Certain studies, including gene therapy studies, will take 90 days, or 180 days if a specialist group or committee is consulted."
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