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Re: flipper44 post# 452868

Monday, 03/21/2022 2:20:45 PM

Monday, March 21, 2022 2:20:45 PM

Post# of 700352
flipper, I can’t explain Northwest Bio’s communications, but just because they didn’t spell it out in plain english, doesn’t mean that the milestone didn’t occur.
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My opinion is that the second milestone was insignificant and easily achievable, because it simply required performing the operations that the system was designed to do. During the validation of the Flaskworks system at Sawston, the Performance Qualification step requires documented verification that the equipment performs effectively and reproducibly, and is capable of performing consistently for multiple cycles and extended periods. So these qualification runs required manufacturing repeatedly for months. If there were any issues, (which I doubt) Advent has some highly qualified personnel in addition to the assistance of Shashi Murthy (who has a large incentive), and the technical staff who invented and tested the system, and conducted the study at Northeastern.
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