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Re: biosectinvestor post# 490390

Monday, 06/27/2022 1:39:09 AM

Monday, June 27, 2022 1:39:09 AM

Post# of 687043
Biosect,

I agree that the U.K. will very probably be first to approve. The question is, how far behind will the others be, especially the FDA. If I were guessing it won't be more than 6 month to a year before all 4 regulators are in. Of course it's very possible the FDA will insist on the FlaskWorks unit being approved and a substantial number of them fully operational before they'll grant approval. I really don't know how high that substantial number may be. I believe FlaskWorks facilities housing tens to hundreds of the units won't take that long to establish if they're done in facilities that already have clean rooms and cryogenic capabilities. If our relationship with CRL is continued into commercial operations, once the FlaskWorks unit itself is approved I don't think it will take that long. I would suspect that within 6 months to a year after FlaskWorks unit approval all production facilities will be converted to only FlaskWorks units.

Gary
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