Dronabinol is off label and can be prescribed by any Doctor now...

Dronabinol is off label and can be prescribed by any Doctor now for breakthrough pain. IRX attempting to create a company that administers the drug as a single API using an off the shelf measured-dose inhaler is neither novel or inventive. In other words, IRX does not have any IP.

Furthermore, the FDA comments received to date suggest that IRX do not have anything worth pursuing. Presumably that’s why they’re trying to pivot and perhaps it’s also the reason Darryl was coy about patentability at the AGM. Is “secret sauce” a pharmaceutical term?

Philip Morris is in the process of acquiring the Israel measured-dose inhaler developer for pain reduction medication, Syqe Medical for $650m. And they invested $20m into Syqe in 2016 which infers they understand the product they’re now acquiring 8 years later. Sapporo, I’m aware of every aspect of the Syqe product as I’ve discussed it with the suppliers at length. Syqe Medical is miles ahead of IRX and being acquired by the giant Philip Morris inhaler subsidiary, Vectura which was bought for $1.44 billion in 2021.

Philip Morris have committed $120 Million just to aid the FDA approvals for the product and so it’s laughable to consider IRX competing against them to develop a measured-dose THC inhaler with a bank balance of $525k. This market is wrapped up and if Philip Morris wanted to sell a synthetic THC inhaler they could easily accomplish it.

These are legitimate criticisms and questions, yet no answers are forthcoming. IRX has no IP and even old faithful supporters like pinkeye are questioning the lack of funding, progress and promotion.

Meanwhile the CEO is in Malaysia, apparently for logistical reasons. Why? It’s an ASX company and as you stated, Camargo is running point on FDA communication. And while Philip Morris spend $120 million on FDA approval for a device they sell today, IRX hope to build a similar product while cap in hand with $525k in the bank.