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drugrunner

04/04/24 2:16 PM

#683216 RE: manibiotech #683198

The path is approval in UK .. FIRST

US FDA … second


Please keep up

meirluc

04/04/24 8:57 PM

#683308 RE: manibiotech #683198

[quoteAnd then why has not an application not been submitted to FDA or any status update given .][/quote]

You know as well as most of us here that no application to the
FDA will be submitted until NWBO can demonstrate that its
DCVax-L manufacturing capacity can satisfy the current
demand in the USA.

Once the EDEN manufacturing system has been validated and
can potentially satisfy the medical demands in the USA, NWBO
will submit a MAA to the FDA.