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Re: flipper44 post# 569137

Sunday, 02/19/2023 6:08:33 PM

Sunday, February 19, 2023 6:08:33 PM

Post# of 697609

If NWBO did not exist. To receive a commercial MIA, Advent still needs to prove they can correctly manufacture a medicine/biologic that is either already approved or “in the process of being approved” before an MIA license will be granted.


ok, so, in other words, you are saying start-up CDMOs in the UK can NOT be granted an MIA without a third-party biotech company and future client, with a product MA approved or in the process of MAA, committing its future production to that start-up CDMO?

I have never read that to be the case and I highly doubt it. Its something the MHRA should be able to answer.

Again I hope you are right seriously.
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