"the U.S. Food and Drug Administration (FDA) advis
Post# of 153903
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Posted On: 06/08/2020 10:14:23 AM
"the U.S. Food and Drug Administration (FDA) advised the Company, subject to its ongoing review, it could receive its “PDUFA date” on July 10, 2020."
FDA accepted BLA, means the application is acknowledged as complete by the FDA
FDA is actively reviewing it which is very good and per the FDA we could have a PDUFA date as early as 7.10
other implication here is that they're actively reviewing the manufacturing and safety portions of the BLA
since safety and manufacturing don't change for covid it's basically like the FDA is reviewing these portions for the covid indication as well
also, if you didn't catch it last week during one of the interviews NP was in he said he had a back and forth the FDA where they wanted more info and he provided it. And within this time frame the FDA accepted the BLA and told us we could have a PDUFA date in roughly a month. The FDA is being responsive and moving CYDY along the process.
FDA accepted BLA, means the application is acknowledged as complete by the FDA
FDA is actively reviewing it which is very good and per the FDA we could have a PDUFA date as early as 7.10
other implication here is that they're actively reviewing the manufacturing and safety portions of the BLA
since safety and manufacturing don't change for covid it's basically like the FDA is reviewing these portions for the covid indication as well
also, if you didn't catch it last week during one of the interviews NP was in he said he had a back and forth the FDA where they wanted more info and he provided it. And within this time frame the FDA accepted the BLA and told us we could have a PDUFA date in roughly a month. The FDA is being responsive and moving CYDY along the process.
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