hyperopia, I think you know it is only a superficial step in the review process whether to accept, give receipt for transmission or to validate a submission. Giving receipt only means the submission was successfully electronically transmitted. Accepting or validating only means the submission appear to have all the required sections. Only the review process will determine the quality of the submission and if anything is left to question the question will be asked and if it is a major question it typically will delay the review or cause the submission to be rejected and the sponsor will need to start over.
Anyone waiting for a submission to be approved has to understand nothing is guaranteed until approval. Typically when labeling discussions are initiated, which is late in the process, the submission is headed for approval imminently though labeling negotiations can still cause a delay but typically do not as the sponsor company will present its case and accept the RA decision at that point.
So, all in, whenever a negative is not conveyed by the sponsor it means all is good. I think NWBO has had sufficient time and access to MHRA contacts to ensure a high quality and complete submission and I am sure they employed MHRA experienced consultants to prepare it. I believe they will do whatever continues to maintain their MHRA relationship including following their wishes for no extra communication steps during review.
GLTA , I look forward to next PR about ASM and submission and believe the last 3 yrs was quality work by NWBO
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