Sharpie, One possible reason for the MIA authorization under “Human” in both 2/27/25 and in 12/15/25 is because Advent additionally leased new space at Unity Campus. Adding an off-site lab expansion possibly requires an update to the MIA.
Another possibility is based on a previous hypothesis of mine. The second authorization could be for a second manufacturing process, Flaskworks, ie the initial, small-scale version. The flow of events in that scenario would be:
- 2/6/24 NWBO PR stated they were going to undertake final qualification and validation of the Flaskworks GMP units.
- ~2024-2025, NWBO was possibly conducting an MHRA informal review of the initial version of Flaskworks validation data, making it near-ready by 7/23/25.
- The MAA was then amended to include this Flaskworks validation data to leverage the new Modular Manufacturing framework (SI 2025/87) on 7/23/25.
- The inspection was successful.
- The MHRA issues a second MIA 12/15/2025 under “human legal basis” to certify this new and additional commercial process (Flaskworks).
- This certification clears the way for the MHRA to issue the final MAA approval.
Bullish
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