Daunting but exhilarating can describe the scene in Silver Spring Maryland on Friday afternoon as our company took its place before the Food and Drug Administration’s (FDA) Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds Part 15 Public Hearing on Friday, May 31, 2019.

The purpose of this day long hearing was to gather additional scientific data and other information related to cannabis and cannabis-derived compounds to help the FDA with their oversight of these products. It was especially important considering the passage of the Agriculture Improvement Act of 2018, Public Law 115-334, better known as The Farm Bill, which removed the plant Cannabis sativa L. or “hemp” from the Controlled Substances Act, among other things.

With a lack of safety evidence in peer-reviewed literature, the FDA wanted to hear from individuals and groups that had a stake in this issue, and they succeeded through a process of inclusion that brought together patients, academics, manufacturers, distributors and of course various levels of government. We are proud to have been given a voice and platform to share what we have learned at Tetra Bio-Pharma over these past years of drug discovery and development.

It should be necessary, important and heartening for anyone connected to Tetra to understand the fact that what we do is fully aligned with regulators like the FDA and this speaks volumes about our business model. Taking the accepted path for drug approvals puts us ahead of the curve on the regulatory requirements and means that we are already well placed to produce the clinical data that not only regulators want, but what physicians need to use cannabinoids in their clinical practice. Let’s not forget for a minute that physicians may not know a lot about how to treat their patients with a cannabinoid just yet, but they do know about scientific data. Demanding evidence of safety and efficacy is in their DNA and it is easy to connect the dots so that when this proof is provided, access to cannabinoids for medical use will be a game-changer.

I am proud to say that we were well represented by Rola Mazloum, Director of Regulatory who used her time wisely to bring forward Tetra’s findings from our three Phase 3 clinical trials and Phase 2 trial. Here’s what she had to say:

• In Phase I trials with inhaled (smoked or vaporized) cannabis, no significant differences were seen in PK parameters (where Cmax was observed between 0.05- and 0.17-hour post-dosing) and adverse events (AEs) were drug-related and mild to moderate in severity.

• Following a single dose of inhaled (smoked) cannabis, the most common type of AEs was classified as nervous system disorders.

• Following multiple doses of inhaled (smoked) cannabis for 7 days, the most common type of AEs was classified as general disorders and negative impacts on cognition were not evident; thus, suggesting a mechanism of tolerance.

• Cardiac and neurologic AEs observed with inhaled smoked cannabis are related to Cmax.

• After 7 days of repeated oral cannabis oil dosing in Phase I study, two of seven patients experienced at least one AE (dizziness and constipation), that occurred and resolved on day 1. No other AEs were reported thereafter.

• In a Phase 2 trial with oral cannabis oil capsules, the ‘’No observed adverse effect level (NOAEL)’’ was observed at 5 mg CBD following daily consecutive intake for 6 days. First AE was observed on day 7 following daily doses of 5 mg CBD.

• Tetra Bio-Pharma detected mycotoxins in several lots, therefore, screening tools and assays were developed and validated for multiple known mycotoxins. Tetra Bio-Pharma performs mycotoxin assays on all raw materials and finished products.

They say you can be judged by the company you keep, and this is not the first time that we’ve sat across the table from the FDA to speak about and share our research.

What’s next? You’ll need to follow our rigorous clinical studies including SERENITY© (Phase 3 in advanced cancer pain), REBORN© (phase 2 in breakthrough pain), OPIOSPARE© (Phase 2 to document opioid sparing effect) and others with cannabinoid-derived products to address unmet medical needs. We are privileged to share our insights and add to the body of evidence.



