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Re: DrHigh post# 721952

Tuesday, 09/24/2024 3:31:23 PM

Tuesday, September 24, 2024 3:31:23 PM

Post# of 828959
Equally, if not more important, is why didn’t they submit reimbursement evidence 6-9 months ago in parallel with MAA submission when UK has been their immediate focus and their survival depends on it.

Although, FDA is 10x the market size of UK, it’s clear that they don’t plan on applying in the US anytime soon because they are worried FDA will not approve based on phase 3 data alone. Otherwise they would have picked US over UK from the beginning. And why wouldn’t you when the TAM is 10 times?
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