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StonkMaster

11/10/25 12:51 PM

#797044 RE: sharpie510 #797041

Why would you do that to us 😅
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NotSure2

11/10/25 12:53 PM

#797045 RE: sharpie510 #797041

In this passage, “the regulators” clearly refers to people within the MHRA, not multiple regulatory agencies.

Here’s why:

The entire paragraph discusses only the MHRA — there’s no mention of the FDA, EMA, or any other authority.

The timeline (“we first submitted the MAA in December 2023”) and the description of ongoing interactions all point to a single agency — the MHRA.

Therefore, when the writer says “the regulators have been very detail oriented”, they’re talking about the MHRA officials or reviewers who are handling that specific application.