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Sunday, 02/26/2023 8:31:36 AM

Sunday, February 26, 2023 8:31:36 AM

Post# of 3990
On another topic of PRX-102 labelling,

I find it interesting that the Japan bridging study is recruiting patients for both the once per 2 weeks and once per month regimens.

Given bridging studies are intended to replicate other studies but with a smaller local ethnic patients, for products and regimens that are already approved in other ICH-GCP compliant territories, this would lead me to believe that PLX & Chiesi are confident for both regimens indications on the EU label at least, probably for USA label too.

Which is nice. Of course confirmation would be on the SmPC following formal EU approval.

Just my personal thoughts, just in case anyone gets confused and assuming I might be saying this will happen :)
(Odd that I now feel the need to specify this when talking about future events outside my control, but hey)
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