RE:RE:there is no reason for IMO ...GMP certificate will be issued soon I do not think we have a problem at all with Aphria been our partner and suplier. This is not in any way bad news for Tetra. This is just a bit of a delay and this latest news about change made by Health Canada is a good change for all involved. IMO this change should have been made/reqiered by HC even beore TBP staring and compleating phase one glad too see this is going in right order now .
RE TBP supply agreement with Aphria.
I copied a part of news from Nov 3 2016 found on Aphrias board
Both Canadian and USA prescription drug regulations impose rigorous quality systems for the manufacturing of both the API and finished drug product. These requirements include conformance to pharmaceutical Good Manufacturing Practice regulations ("GMP") as well as demonstrating the ability of the manufacturer to ensure lot-to-lot consistency in the quality and safety of the prescription drug.
Dr. Guy Chamberland, M.Sc., Ph.D., Chief Scientific Officer and Regulatory Affairs, PhytoPain Pharma Inc., commented, "We are very pleased and excited to be working with Aphria in the development of PPP001. Developing prescription botanical based pharmaceuticals requires a high quality GMP system and well-established product specifications to ensure consistent efficacy and ultimately protect the safety of patients. Based on our assessment of Aphria, we are confident that their high quality GMP medical cannabis production facility and impressive quality assurance team will meet or exceed the expectations of both the Canadian and USA prescription drug authorities."
"With this agreement in place, PPP is now in a solid position to submit its Clinical Trial Application (CTA) for its planned Phase I trial in healthy volunteers. The company is also on track for submitting its Pre-IND Information Package for its upcoming meeting the US FDA," stated Dr. Chamberland.
"Aphria is excited and proud to be an integral part of advancing the scientific research being led by Dr. Chamberland and the team at Tetra Bio-Pharma. Using our proprietary and high quality medical cannabis blend supported by high calibre research is exactly what professional healthcare practitioners require to gain the confidence to prescribe medical cannabis as a pharmaceutical," said Vic Neufeld, Chief Executive Officer, Aphria Inc.