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Re: hyperopia post# 445343

Sunday, 02/20/2022 7:56:16 AM

Sunday, February 20, 2022 7:56:16 AM

Post# of 702511
hyperopia, you speak like you have experienced 'projects' like this. Your commentary is excellent, thx for the post and the process explanation for all to better understand the undertaking here.

Constructing and transferring while automating has its challenges. In this mfg space, as you well explain, the process is the product and the facility is intertwined into the process. All of this is brought together in the BLA and the challenge and my question is whether the automation (Flaskworks) of the back half of the process will be incorporated into the BLA for quicker capacity ramp post launch or included into a post approval submission, which is more likely given all the moving pieces they are developing. They need a submission cutoff as well as they need good comparative data baselines to work from to demonstrate comparability of results. We won't know the answer until they tell us the plan or give an addl clue.

Thx again and GLTA
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