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Posted On: 11/27/2023 1:43:49 PM
Post# of 148863
Since Cytodyn revealed in their Nov 3 letter that they had submitted the information asked for by the FDA to lift the hold, the clock should have started by Nov 3. The FDA says it will respond in 30 calendar days, which means Cytodyn should hear back by Dec 3. With 4 business days to report a material event, Cytodyn should be making a statement by Dec 7, Thursday. Someone correct me if this is not accurate.
FDA 30 calendar days response:
https://www.fda.gov/media/72548/download
Material event 4 business days response:
https://resourcehub.bakermckenzie.com/en/reso...-reporting
FDA 30 calendar days response:
https://www.fda.gov/media/72548/download
Material event 4 business days response:
https://resourcehub.bakermckenzie.com/en/reso...-reporting
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