TETRA BIO-PHARMA WKN: A2ASQ8 ISIN: CA88166Y1007 Kürzel: TBP Forum: Aktien Thema: Hauptdiskussion

Erstmal natürlich positiv, aber nicht so richtig ein Hammer. Aber hoffentlich geht es mal wieder nachhaltig nach oben

TETRA BIO-PHARMA'S QIXLEEF(TM) ON TRACK AFTER TYPE C MEETING WITH U.S. FDA Tetra Bio-Pharma Inc. has 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 non-clinical safety requirements for the marketing approval. Guy Chamberland, chief executive officer and chief regulatory officer of Tetra Bio-Pharma, commented: "The November, 2021, news release confirmed that Qixleef aerosol, generated by the Mighty Medic medical device, met the U.S. 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 show that Qixleef might become an alternative analgesic to reduce the use of opioids in patients with severe or chronic pain. An alternative to opioids is long overdue."

Jetzt bin ich auch bald bei Verzweiflung, Health Canada genehmigt die Änderung einer Studie… Hammer 🙈

Management Update: https://www.newswire.ca/news-releases/tetra-bio-pharma-provides-management-update-863976103.html

Verzweiflung vielleicht, weil nix anderes klappt 😴

Nahrungsergänzungsmittel 😳 wo kommt das denn jetzt auf einmal her. Hatte ich nicht auf der Liste