Business
Voyageur Pharmaceuticals Provides Update on PEA Progress & Takes a Major Step Towards Production Start Up
(TheNewswire) Calgary, Alberta - TheNewswire - December 6 , 2...
About this update from Voyageur Pharmaceuticals Ltd
[{"type":"text","content":"Voyageur Pharmaceuticals Provides Update on PEA Progress & Takes a Major Step Towards Production Start Up\n \n \n (TheNewswire)\n \n \n \n \n \n \n \n \n Calgary, Alberta -\n \n \n TheNewswire -\n \n \n December\n \n \n 6\n \n \n ,\n2021 -\n \n \n Voyageur\nPharmaceuticals Ltd.\n \n \n (TSXV:VM)\n \n \n (\n \n \n OTC\n \n \n :\n \n \n \n VYYRF)\n \n \n \n (the \"Company\"\nor \"Voyageur\")\n \n \n has a preliminary\neconomic assessment (PEA) on its Frances Creek project pending with\nSGS Canada, who have stated the first draft will be completed by mid\nDecember. There have been delays outside of management's control.\nBuilding out the mining operation and product manufacturing represents\nthe second phase of Voyageur’s plan.\n \n \n \n \n Voyageur is working with its manufacturing partner;\nAlberta Veterinarian Laboratories / Solvet and has completed its first\ntest batch of barium  contrast media. Voyageur is working on clinical\ntesting of this first batch to ensure quality and performance.\nVoyageur's goal is to complete testing for the Canadian product launch\nby February followed by a marketing campaign for sales into the\nCanadian radiology market.\n \n \n \n \n Voyageur is focused in the near term on developing a\nsuite of Computed Tomography products with the lead product being the\nSmoothX barium contrast brand. The FDA is currently working with\nVoyageur on creating a new regulatory pathway, to create a device\nregistration. Voyageur expects to submit its device application as\nsoon as the new guidelines are approved by the FDA. Voyageur will\nprovide updates on FDA progress, as each milestone is achieved.\n \n \n \n \n Voyageur plans to penetrate the US market upon\ncompletion of FDA device licensing, that is estimated to be completed\nin 2022. Voyageur is concurrently creating a drug dossier for foreign\nmarkets (EU/Uk/Japan) that regulate barium sulfate as a drug.\nVoyageur’s objective is to have regulatory filings for SmoothX into\nthe UK, EU and Japan, and initiate the penetration into the global\nmarkets by end of 2022 to 2023.\n \n \n \n \n Concurrently Voyageur is proceeding with multiple batch\ntesting of its product to meet FDA and EU regulatory standards for\nlicensing requirements. This work is directly tied into the FDA and EU\nregulatory approval process.\n \n \n \n \n About Voyageur\n ...