inhaled delta-9-tetrahydrocannabinol (HCC011) / Tetra Bio-Pharma - LARVOL DELTA

Tetra Biopharma confirms type B meeting date with FDA regarding HCC011 (GlobeNewswire) - "Tetra Bio-Pharma Inc...is pleased to announce that the U.S. Food & Drug Administration ('FDA') has granted the Company’s request for a Type B meeting related to its proposed clinical program and overall premarketing requirements for the Company’s product HCC011 with Orphan Drug Designation. This meeting has been scheduled for May 29, 2020....On May 29, the FDA will be providing guidance on our planned phase 2 clinical trial, expedited review paths, and 505(b)(2) premarketing requirements."

FDA event • New P2 trial

Tetra Bio-Pharma enters into manufacturing agreement with Vitiprints LLC for Caumz and HCC011 (GlobeNewswire) - "Tetra Bio Pharma Inc...today announced it has signed a definitive manufacturing agreement with Vitiprints LLC, for the commercial scale production of CAUMZ™ and HCC011. This agreement will further protect CAUMZ™ and HCC011 with four additional patents on manufacturing know-how...In exchange of this exclusive license Tetra will be required to make milestones and royalty payments on CAUMZ™ sales. From a financial standpoint this proprietary technology will allow Tetra to reduce it Cost of Goods Sold (COGS) for CAUMZ™ by approximately 75% and will significantly improve CAUMZ™ gross margin."

Licensing / partnership

Tetra Bio-Pharma provides update on its hepatocellular carcinoma drug HCC011 (GlobeNewswire) - "Tetra Bio-Pharma Inc...announced it will be requesting a meeting with the U.S. Food and Drug Administration (FDA) to discuss the drug development program for its Orphan Drug candidate HCC011, inhaled delta-9-tetrahydrocannabinol (THC), in the treatment of hepatocellular carcinoma...The company intends to file an NDA for HCC011 via the 505(b)(2) pathway....Post our meeting with FDA, we hope to gain clarity on our filing and marketing requirements, including input from the Agency on the design of our planned Phase 2 trial for HCC011 in HCC."

FDA event • NDA • New P2 trial

Newly added product (GlobeNewswire) - Preclinical, Oncology, HCC

Pipeline update