Based upon DI’s response to survivor, I think they are with commercial (Flaskworks) GMP preapplication timing, where they were with Advent/Sawston preapplication timing back around early May 2021 — just before the May 12, 2021 PR ( that announced application submission). However, I think there are a number of differences that will make any commercial GMP manufacturing application process go faster.
1. I doubt the MHRA inspectors will be as unavailable as they were over the holidays and Covid.
2. This is not going to involve an entirely new facility review with the Flaskworks system.
3. If you recall, they really only needed to make some minor adaptations between acquiring Flaskworks and modifying the invention to create the prototype that began testing last summer.
4. The number of protocols and persons involved in each number of reduced steps is streamlined.
5. The assays were previously developed and approved to show comparability between London (manual) and Sawston (manual), therefore biocomparability analysis should be streamilined to (have) compare(d) Sawston manual product in relation to Sawston Flaskworks product automatically manufactured.
I hope I’m making sense here.
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