Saturday, July 19, 2025 1:49:15 PM
In that no one outside the company and its contractors, as well as all involved in the UK, know what has transpired in the past over 18 months, it is all speculation as to whether the EDEN Unit is included, or not. While I certainly hope so, I am only guessing that it's included.
Per LP, they have not yet even had the final GMP EDEN design built yet and they will start on internal validation after delivered. And then the comparability data/study.
So it is friggen obvious it is not in the MAA. And not what the holdup is.
Yup, I am speculating there is no baby unicorn being born "soon".
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