Your post relies on assumptions and wishful thinking, plain and simple. Some parts are grounded in regulatory structure, like the role of the SmPC, but the leap from “NICE hasn’t received the SmPC yet” to “labeling began on July 16 and will end by August 13” is speculative. That timeline could be roughly accurate, or completely off if MHRA is still resolving a CMC issue, Flaskworks validation, or internal QP concerns.
You are
Claiming we're in the labeling phase now? Plausible but not proven.
Claiming approval must come by mid-August? Wishful thinking unless verified. I hope you are right and the SP gets over $1 and I can sell this turt
Citing PMG24 rules? That part is correct.
AI structured, but still speculation dressed up as inference.
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