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Tetra Bio-Pharma's QIXLEEF™ on Track After Type C Meeting with U.S. FDA
Tetra Bio-Pharma's QIXLEEF™ on Track After Type C Meeting with U.S. FDA.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\n\n\n\nTetra Bio-Pharma's QIXLEEF™ on Track After Type C Meeting with U.S. FDA\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's QIXLEEF™ on Track After Type C Meeting with U.S. FDA\nCanada NewsWire\nOTTAWA, ON, March 17, 2022\n\n\n\nThe Type C meeting with the FDA provides guidance to strengthen QIXLEEF™ nonclinical and toxicological data package for marketing approval. OTTAWA, ON, March 17, 2022 /CNW/ - Tetra Bio-Pharma Inc. (\"Tetra\" or the \"Company\") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development received the response letter for a Type C meeting with the United States Food and Drug Administration (FDA) for its inhaled cannabinoid-based product, QIXLEEF™.  The meeting was held to discuss the nonclinical safety requirements for the marketing approval.\n\n \n \n \n \n \n \n\n \nGuy Chamberland, CEO and CRO of Tetra Bio-Pharma Inc. commented, \"The November 2021 news release confirmed that QIXLEEF™ aerosol, generated by the Mighty Medic® medical device, met the USA cGMP regulatory requirements, including the delivered-dose uniformity (DDU) criteria, established by the FDA for inhalation aerosols. Last month, we announced that preliminary data from over 40 episodes of breakthrough pain in each of the experimental and active treatment groups suggested that QIXLEEF™ could be an effective analgesic for pain management.  This new feedback provided by the FDA is very good and will allow the Company to refine its toxicology plan and address the key issues that are of concern to patients who will want to use QIXLEEF™ for a relatively long period of time. The interactions with regulators, like the FDA, are critical for both the Company and shareholders. The FDA guidance will pave the way for marketing approval and allow the Company to elaborate cost-effective strategy as part of the drug development program. To date, our data shows that QIXLEEF™ might become an alternative analgesic to reduce the use of opioids in patients with severe or ...