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Re: kabunushi post# 670718

Thursday, 02/08/2024 8:45:53 AM

Thursday, February 08, 2024 8:45:53 AM

Post# of 700471
kab, the timeline that I proposed for the Flaskworks process approval was rather imprecise, since we don’t know many details. I think that commercial production startup timing may primarily depend on the timing of the marketing approval, estimated approval of the Flaskworks process, and price negotiations with NICE (which are likely based on automated manufacturing), so there’s a few moving parts, each with their own timeline. Those timelines should become clearer the further along they are, but I’ve said that I believe the timelines will come together, and think the plan has been for automated commercial manufacturing from the start.

Generally, there is some time lag between the marketing approval and commercial production startup, as market awareness activities begin, customer care network is set up, protocols are established with hospitals, etc., but I agree that manual production could begin if necessary, once all the pre-commercialization activities are completed, in case the Flaskworks timeline gets extended.
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