No, but they gave us good commentary on the way forward,
"...data supports PPS entering the therapeutic landscape"...and...."The TGA further recognised that Paradigm provided sufficient evidence to support its plan to submit comprehensive clinical data..."
But most importantly,
"...the TGA agreed that the proposed phase 3 OA program, if successfully executed, will provide the necessary evidence to support full registration of PPS in Australia".
Nice to get that positive feedback.
Ann: Paradigm Secures Ethics Approval for Phase 3 Trial, page-44
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