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Replies to post #627059 on NorthWest Biotherapeutics Inc (NWBO)
dennisdave
08/31/23 11:23 AM
#627067 RE: extrooper #627059
the Agency concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.
As I’m sure you heard on the call, the company believes the primary issues are CMC (e.g., manufacturing).