flipper, I don’t think it is, or ever was the plan to use the manual process for commercial production for the reasons I’ve explained. But just because I’m convinced, doesn’t mean it’s right. Anyone can think or argue otherwise. It’s possible that the initial plan was to use the Flaskworks system for investigational use at Sawston as an interim step while it was being developed and validated for commercial use. But if that ever was the plan, I think it was probably scrapped when the initial license at Sawston was delayed. That delay was when my thinking about Flaskworks changed to Advent developing and validating the entire automated commercial process.
I said in another post that it was difficult to tell exactly where Advent was with automation, even after the ASCO presentation, and that may have been intentional. Looking back, now that we know the application for a commercial license has been submitted, I’m recalling a tweet in early April “Sawston hiring a 2nd shift. Flaskworks installing a production line for certification.” (likely leaked from Loose Lips Les) So I think the comparability study was probably done in April, which would allow enough time to analyze the data and prepare the regulatory documentation. Also, in that ASCO presentation, they did describe the automated process as the future, but then at the end said “The Future is Now.’ That seemed odd when I first watched it, and I remember wondering what that meant, but it seems more clear to me now. Regarding “the work done in the course of the last month,” I will just note Mike Scott’s comment, “Our Team has put in an extraordinary effort to meet our self-imposed, end of Q2 deadline to submit the MIA application.“
