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Re: exwannabe post# 691357

Tuesday, 05/14/2024 8:27:17 AM

Tuesday, May 14, 2024 8:27:17 AM

Post# of 699596
That’s in Europe Ex, and NWBO did not modify their MAA. You are wronger than wrong.

Here is what Europe does

The Agency will ask the applicant via a request for Validation Supplementary Information (VSI) to submit the additional information, clarifications or corrections.
. The applicant provides the above additional information within the validation timeline. If the additional information submitted is as requested, the Agency will confirm the positive validation to the applicant.



That adds to the MAA Ex.

Whereas, NWBO states the MAA was never added to nor amended.

The Company did not make any amendment or addition to its MAA after the original December 20, 2023 submission. — NWBIO May 10, 2024 10q

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