dmb, as I’ve said, I’m not as familiar with procedures in the UK, but I believe that the MHRA only uses software tools to validate the application, and recommends that the applicant first perform a validation using the recommended software tools prior to submitting the application, so I’m unsure how an error could occur, unless perhaps some element is missing.
I’m not sure if it’s still true today, but not too long ago, that validation process differed from the US, where the FDA only validates parts of the application with software tools, while other parts are validated by humans, so validation in the US seems to take longer.
And I definitely agree that Northwest Bio has had “sufficient time” to prepare a high quality application, some might even say more than sufficient time. With all Advent’s workstreams developing manufacturing for comparability, stability, potency, product profile, fill/finish, Bosch’s proteomic analysis on the mechanism of action, Shashi Murthy’s work on the potency assay, and I’m quite sure there was more. So yes, it better be complete and high quality!
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