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Tetra Bio-Pharma Receives Positive Scientific Advice Assessment (SAA) Report for QIXLEEF™
Tetra Bio-Pharma Receives Positive Scientific Advice Assessment (SAA) Report for QIXLEEF™.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\n\n\n\nTetra Bio-Pharma Receives Positive Scientific Advice Assessment (SAA) Report for QIXLEEF™\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n\n\n\n\n\n\nTetra Bio-Pharma Receives Positive Scientific Advice Assessment (SAA) Report for QIXLEEF™\nCanada NewsWire\nOTTAWA, ON, Sept. 2, 2021\n\n\n\nSAA Report endorsed Tetra Bio-Pharma's proposed nonclinical development and quality programs for QIXLEEF™. SAA Report provides clarity on clinical requirements for registration in Europe. OTTAWA, ON, Sept. 2, 2021 /CNW/ - Tetra Bio-Pharma Inc. (\"Tetra\" or the \"Company\") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development is pleased to announce that it received the Scientific Advice Assessment (SAA) Report from the Malta Medicines Authority.  Overall, the SAA Report provided positive feedback on Tetra's drug development plan for QIXLEEF™ and eligibility for submitting a Marketing Authorization Application (MAA) under Directive 2001/83/EC (Directive). QIXLEEF™ is the Company's inhaled proprietary drug which has a fixed ratio of THC and CBD. The medication is inhaled through a Class II medical vaporizer.\n\n \n \n \n \n \n \n\n \nThe SAA Report endorses Tetra's 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.  \nThe 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. The REBORN2© trial was identified as pivotal for the MAA because of its dose-response endpoint requirements of the Directive.  Depending on the outcome in the REBORN1© and REBORN2© clinical trials, full Marketing Authorization would require confirmation of the outcome of REBORN1©. \nDr. Guy Chamberla...