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They received a Refusal to File stating “The FDA
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Post#
of 142674
(Total Views: 798)
Posted On: 07/13/2020 6:12:55 AM
Posted By:
Shopcop7
Re:
Investor1.2
#42503
They received a Refusal to File stating “The FDA has informed the Company its BLA does not contain certain information needed to complete a substantive review and therefore, the FDA will not file the BLA at this time”.
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