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exwannabe

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exwannabe

Re: saxxie2 post# 673016

Sunday, 02/18/2024 10:25:49 PM

Sunday, February 18, 2024 10:25:49 PM

Post# of 701406

Could it be that submitting in the UK will lead to approval in all these Orbis partner countries! Fingers crossed!


No,.

ORBIS is run by the FDA. The review is run by the FDA based on the NDA/BLA. The other countries may participate in the process, but do not run it. Once the FDA staff review is compete the countries make their own decisions
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