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Tetra Bio-Pharma Inc. (OTCMKTS: TBPMF) Obtains an Approval of the Proposed Protocol Modifications to Accelerate the REBORN Study



Clinical trials are an essential component of any drug discovery and development program. Innovative research initiatives are the cornerstone upon which the success of the trials is built to deliver quality. Tetra Bio-Pharma Inc. (OTCMKTS: TBPMF) has made history using evidence-based scientific approaches, which have produced a pipeline of cannabinoid-based drug products for a range of medical conditions. And having given priority to patient’s demands, the company focuses on providing rigorous, scientific, safe, and validated data for use by the biopharma industry. 

In cannabinoid-derived drug discovery and development leadership, the company can now carry out the proposed protocol amendments, which will allow supplementary immediate-release oral opioids. They will be uses as comparators in the REBORN1© study. The approval by the Central Ethics Committee opens the enlistment of cancer patients with breakthrough pain. However, they should have had treatment with either oral morphine sulfate immediate release, oral oxycodone immediate release, or oral hydromorphone immediate release. The previous comparison was between QIXLEEF™ and oral morphine sulphate. 

Making QIXLEEF Become an Alternative Prescription Therapy to Opioids

The primary aim of Tetra Bio-Pharma is to bring to the industry novel prescription drugs and treatments to patients and their healthcare providers. Hence, the approval by the DEA would not have come at a better time than now. QIXLEEF is inhaled proprietary drug formulation and has a fixed ratio of THC and CBD. It is inhaled through a Class II medical vaporizer.

Expressing the company’s appreciation of the approval, the company’s CEO and CRO, Dr. Guy Chamberland, said, “The amended protocol allows QIXLEEF™ to be studied against three types of immediate-release oral opioids instead of just one. It will facilitate the recruitment of patients who can benefit from QIXLEEF….” 

In other news, it is worth bringing out the resignation of the company’s Chief Financial OfficerJean-François Boily as from July 16th, 2021. He had served in this position for nine months. Meanwhile, an executive search is underway to identify his replacement, but the company will in the meantime use its internal finance team and also retain the services of a consultant to serve as CFO. This will ensure the flow of financial reporting obligations.

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