General discussion, page-10991

@Hangover (apologies for the length of this reply in advance)

Epidiolex is the only FDA registered and approved medication containing CBD.

That's what will drive the IHL value proposition in the CBD medicated space just as it did for GW Pharma and that first mover medication that they brought to market themselves.....Epidiolex - researched, trialed and funded in house to the tune of US$25 mill.

link
FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) | FDA



The BOD here have had the foresight and expertise to realise that this regulatory opportunity still remains untapped by any other company .....think about that for a moment ....it equals many multiples of the current sp yet to be unlocked.
all the many hundreds of millions of dollars that have been poured into the sector in its entirety and still there is only one medication with FDA approval in the cbd space. Mind blowing really isn't it.

The reason for that is very simple and Sud saw it first hand in Canada in 2018. The Canadian research and development in the space was progressing well prior to 2018 and it seemed there would be a number of Canadian based companies that would follow the FDA registration pathway ....then it was smashed wide open in 2018 when legislation removed criminal conviction bar for access to....and the personal use of marijuana. They did this to try and avert the opioid crisis swallowing up the country....what they are now starting to deal with is an un monitored unregulated decriminalised personal use in cannabis ....it will be interesting to see what unfolds across the next few years over there in that regard....
..and still the regulatory opportunity remains wide open

That simple act saw money for R&D stop and shift to the 'personal use' market as there was a fast dollar to be made in non pharmaceutical product and it consequently exploded across the country in a 'legal' corner store available format.

So IHL holds the ACES!
They will own the differentiation value once these FDA approved drug candidates arrive - imagine the investment that will follow that registration approval and they potentially become only the 2nd company ever to have FDA approved CBD drug candidates in the market place addressing unmet need and returning revenue.

This is the value proposition / case for this amazing startup...and the blind market place is only now starting to wake up to its potential future value......that's the real return of the value case here with this company ....the potential future value is ???
@Glitterati in a post just up the thread mentioned $5.00 sp.....pretty sure some will give that the big 'oh yeah sure....righto then'!
....i believe the company value of these guys in the US with their proposed product pipeline and the FDA approved drug candidates will be a long way north of $5.00.....there is nothing that I've found that comes close to what these guys are bringing to the space....nothing !
Happy to be corrected of course...
they intend to then take it globally - according to their prospectus......wow....what value at that point....mind boggling i think.


the counter argument is ...well why won't the legalised space 'cruel' IHL the same way?

the FDA requirement for medications containing CBD is that they must be 98% CBD only.....pure.
ie ....IHL-675A combinant medication comprising Hydroxychloroquine & CBD....the CBD component must be of that purity no variation, no deviation, no other trace elements of any sort other than CBD...yep...its a very high bar
Incannex again are right on top of this requirement as indicated by the current IND approvals granted and sort for their medications.
TGA Schedule 3 here in Australia has the same barrier to entry as the FDA...98% cbd only GMP purity......and must provide safety profile and efficacy commensurate with successful clinical trials.....thats why there are no listed Schedule 3 CBD medications here in existence.....what an opportunity waiting to be capitalised on.

Basically Incannex will own the space @Hangover.....investors will then ask questions of other companies in the space as to why they have not pursued the same pathway to value and returns over time....they are perhaps asking that now....hence the retracting values you point to.
These companies.... a vast majority ...have alluded to real world evidence / real world data as an alternate pathway to registration to appease their shareholders and venture capitalists in the space and point to such statements made by the FDA as it being a new pathway to registration. They are correct except for the fact rwd/rwe only applies to currently FDA registered and approved medications and devices that may be useful for new treatment indications.

Needless to say there are no CBD products registered and approved by the FDA other than Epidiolex, so it is not an applicable pathway to follow for that singular reason.....this applies to all the companies in the medicinal cannabis space globally who make such pronouncements - if those companies are using Epidiolex as one of the drugs in their research to address the CBD medication space then such data and evidence would be of value and meet the FDA criteria for its application because it meets that high bar of 98% purity according to the requirements of GMP and it already has prior approval....but again, i know of no company doing this with Epidiolex in their research for pharmaceutical grade medication and moving it in trail to the FDA for approval.

Incannex have understood this from day one......brilliance imo....and the share price movement is really starting to reflect that unfolding understanding and the real depth of the value opportunity this company is on the verge of unlocking in the CBD medication space.

the take away
Once US investors see this opportunity arrive across their desk I don't believe it will be viewed as another cannabis company taking advantage of legislation allowing a dollar to potentially be made in the personalised / decriminalised space......they will see it as a pharmaceutical company arriving with a value case that has the potential to return many multiples on your original investment over time due to the size of the unmet need / market opportunity that remains for those who succeed in the FDA / TGA approved space.

And this is just the CBD medication space Incannex are working to unlock

Wish them all the best in 2022 for all our sakes.