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Re: exwannabe post# 363764

Monday, 03/22/2021 3:05:23 AM

Monday, March 22, 2021 3:05:23 AM

Post# of 713733
Not surprised by your timeline ex, but there is “no way” that it will take until June or July 2022. I will admit that four months was a very optimistic guesstimate, but with 30+ employees on Advent’s payroll now, there’s likely to be some urgency. I also thought there may be a speedier application process after reading this: “Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.”

But thinking about it some more, Advent has already missed the first 8-month window (by a year!) and we don’t actually know if the SOW’s included certification. I guessed that the application would be submitted within 6 weeks, and it would be processed in 90 days, but this is Northwest Bio after all, and I double checked and it’s actually 90 “working” days, and further delays due to the recent Covid lockdowns should probably be expected. So upon further reconsideration, I will revise my optimistic guess that Sawston facility will be licensed and certified by September/October.
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