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Re: hoffmann6383 post# 433812

Monday, 01/10/2022 2:06:03 PM

Monday, January 10, 2022 2:06:03 PM

Post# of 821231
Cognate/CRL has capacity, they are just doubling it at the Shelby (original) location. I don’t think the U.S. goes first with commercialization, but not for this reason. The reason I believe is that the equivalency/comparability will be proven first in the UK because of the new guidelines in the MHRK streamlining/advancing the ability to demonstrate comparability without efficacy clinical/pre-clinical bridge studies in most cases.
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