IRX 616a World 1st Fast Acting Non Addictive Anxiety Solution, page-8

It's a really good question @vacre and welcome to the modest but imo smart IRX online community. Your deep research will be an asset to discussion here. The answer to your question is long and ironic.

I've got the utmost confidence that IRX 211 will get FDA approval.

First of all, the FDA is clearly comfortable with synthetic THC. It has already approved 3 synthetic THC products, yet it hasn't approved any naturally derived THC ones.

Secondly, because synthetic THC has been around since the early 80s, its side effects are well known. In short, patients and the FDA trust it. IRX 211's proposed synthetic THC aerosolized solution feels like the logical extension, as both synthetic pill and liquid form already have FDA approval.

The third reason is because I know very well first hand the pain relieving effects of THC, as do hundreds of millions of people all over the world. Its effects are not universally called "getting high" by accident.

Which brings us to IRX 616a. CBD is an industry in its infancy. While THC has millennia of history, isolated CBD is completely new and its effects are still emerging.

There has only been one CBD product approved by the FDA, and it was naturally extracted (remember irony). That company was acquired for around $7 billion USD.

By stark contrast, as regards synthetic CBD, the FDA has approved 0 products. That's right - not a single one in any form (pill, liquid, or aerosol), nor for any indication. Clearly the FDA's trust remains a hurdle. It would be better if another company swooped on an FDA approved pill form to clear the way.

It's easier to go up step one to two then jump to three.

Isolated CBD - naturally extracted or synthetic - has little history beyond anecdotal evidence from international friends and Reddit.

In summary, the FDA prefers synthetic THC, but ironically prefers natural CBD so far. Neither has the company promoted this clinical asset well at all either.

I wouldn't mind if the company drop this asset altogether, but that's my ignorance talking.

Reddit commentaries are one thing, so I've booked a trip next month to Thailand to find out for myself.

GLTAH