IRX 616a World 1st Fast Acting Non Addictive Anxiety Solution, page-9

According to Chat GPT, the likely winner for the world's first FDA approved synthetic CBD product is Avata SAP-021 in late 2027. This is actually pretty interesting, and there is a distant link with IRX.

Don't be alarmed. It's not a competitor for us, and it will help push our cause with the FDA. While it would be legendary to be the world's 1st FDA approved synthetic CBD product, Avata would also cut a lot of red tape and help pave the way for future FDA approval of IRX 616a.

To highlight its differences, Avata SAP-021 is a slow acting oral capsule, and unsurprisingly, it is for the treatment of epilepsy. Thus far, epilepsy is the only medical condition that the FDA has given the green light to for CBD.

As a result, Avata SAP-021 would be a direct competitor to Jazz Pharma's natural CBD oral formulation, Epidiolex. The money involved is jaw dropping. Epidiolex's sales have grown each year since FDA approval and it almost hit USD$ 1 billion last year.

Avata SAP-021 have only completed a phase 1 (Parts A & B) meaning they're not that far ahead of us, but the reason Chat GPT gives is they can leverage Epidiolex's safety and efficacy data for epilepsy and potentially jump straight to a pivotal phase 3.

The interesting part is the co-founder of Avata is Dr Andrew Saich, a former director of IRX and shareholder, or at least he was the last time I checked (February, 2025).

It's a small world after all.