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Tuesday, May 14, 2024 9:15:15 AM
Europe EMA
What are the main principles that my application should follow in order to pass validation successfully?).
. 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.
. The scientific evaluation will start on the next available start date according to the Agency timetables.
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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