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Re: hankmanhub post# 555489

Tuesday, 01/03/2023 9:46:37 AM

Tuesday, January 03, 2023 9:46:37 AM

Post# of 722608
Hankman, Linda made it clear that the product application would go out to multiple regulators, which might be a tip of the hat toward ORBIS, which involves multiple countries or RAs. She certainly at this point knows who they’ll submit the application to, after all, they have to fill in the paperwork for the correct filing, but they obviously don’t want to tell us yet. I don’t know why. I found it interesting that she never refers to the application as a BLA, just as a product application. I don’t know if that’s significant. Is it called a BLA in the ORBIS program, or in other specific programs? Maybe somebody who understands the application process can answer.
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