The response package to the US FDA has been submitted as directed by the Agency,
through a request for review pathway. The request for review pathway does not have
strict Prescription Drug User Fee Act (PDUFA) Agency response timelines, although
feedback is typically received within three months.
Why doesn't Paradigm say to the market exactly which review pathway they are answering to?
Subject to FDA clearance, Paradigm intends to promptly move forward with subject
enrolment into the phase 3 clinical trial (PARA_OA_012) in 2H CY2024.
Seeing this is an entirely new trial, it would suggest the entire program is being re-thought.
There is no mention of submitting a DMOAD approach.
The response package to the US FDA has been submitted as...
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