Trial Profile

A clinical trial of PPP001

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 13 Sep 2021

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At a glance

13 Sep 2021 New trial record
02 Sep 2021 According to a Tetra Bio Pharma media release, The SAA Report discusses the assessment of both the PLENITUDE and REBORN clinical programs with regards to a MAA. The SAA Report provides guidance on the endpoints and other aspects of the protocol.Depending on the outcome in the REBORN1 and REBORN2 clinical trials, full Marketing Authorization would require confirmation of the outcome of REBORN1.
02 Sep 2021 According to a Tetra Bio Pharma media release, The SAA Report endorses company proposed plan to address the nonclinical safety requirements for submitting a MAA for QIXLEEF. Similarly, the SAA Report endorses the Company's quality program for QIXLEEF as a medicine. In both cases, the SAA Report provides guidance on requirements for MAA approval.

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