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Posted On: 05/12/2020 12:15:40 AM
Post# of 153903
an example? bla papers were submitted april 27.
https://www.cytodyn.com/newsroom/press-releas...pplication
the may 4 pr states this below that fda{ read the bla filings submitted april 27 ] made comments for further data.
"The clinical datasets are updated to address FDA comments for mock datasets from March 12 and March 20, 2020. After the BLA submission is considered completed, FDA makes a filing decision and sets a PDUFA goal date."
https://www.cytodyn.com/newsroom/press-releas...pplication
the may 4 pr states this below that fda{ read the bla filings submitted april 27 ] made comments for further data.
"The clinical datasets are updated to address FDA comments for mock datasets from March 12 and March 20, 2020. After the BLA submission is considered completed, FDA makes a filing decision and sets a PDUFA goal date."
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