What’s likely happening is not a delay. It’s a controlled alignment. SI 87 changed the law in the UK. Flaskworks reached automation readiness
Uhm, really?
First, we know that NWBO is waiting on the C cleanrooms before they even have the EDENs designed to be GMP client delivered and start testing, So they are not even close.
Second, what that law does is allow additional MFG sites to be approved under the "parent" license. NWBO has spend 2 decade and well over 100M building LP's 2 CDMOs. The idea others will just spout up is kind of hard to make work.
The idea that the MAA is being held up for EDEN is, and always has been, total quackery.
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