Chopper, appreciate your posts.
Assuming it’s not a labelling or manufacturing supplement, seems odd if the guidelines don’t specify a timeline to acknowledge a complete resubmission. I wonder if para 4 is the one that applies, on the basis that this is considered a “original application supplement” or “efficacy supplement”? If so, 14 days still applies. Not an expert, just a thought.
MSB 2023 - awaiting for Ryoncil approval, page-602
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