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Re: barnstormer post# 769345

Tuesday, 05/27/2025 2:06:36 PM

Tuesday, May 27, 2025 2:06:36 PM

Post# of 823808
MHRA standards are the same. The novelty of the approach and the complexity of the process will require MHRA to spend more time on learning and understanding the potential issues.

The way the trial was conducted is unusual. That alone will generate some questions and discussion. Then there is the biologic process which is novel and will also generate questions and discussions.

Nunc est Bibendum

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