Ann: Emyria partners with PAX Centre for MDMA-assisted therapy, page-6

When we come to phases 3 & 4 we start talking about trial sizes of 100s (400), and then into 1000s (4000), you'll often see multiple trials of 500 odd to get that number up there. Also when you consider the traditional model of trial, seeing results, reacting to results & make changes, in the trial setting this is costly, the feedback loop and ability to react and change is very slow. This is where the $1B comes from to take a drug to market.

When we get special access schemes we are unique (and it's why Australia is the best place to be both in its regulatory framework, and the lovely R&D tax rebate). We can get some of this evidence about what works or doesn't work outside of an expensive and long clinical trial setting and react and make changes.

When we come to this drug development we are talking about "the recipe" as this is what can be patented (cannabis/mdma is a natural substance and can not be patented. look at GW phama product its some CBD in grape seed oil nothing special) however what is special, is that they were the first to know "how much, how often, for x condition" (see my other post about how EMD is also able to patent its cannabis and mdma products as its using synthetic analogs).

Now back to RWD;
EMD is working two-fold, 1) it has the first TGA registered capture device so that the data can be used in clinical evidence, and 2) the RWD it captures is compliant that can be used as evidence for the TGA/FDA - lots of companies (IHL included) have this 'anecdotal data' because of the special access scheme, but they are unable to use it as supportive evidence. (Our CEO worked with Palantir + Sonofi + FDA to help produce the FDAs white paper on RWD).

Now when we come to the special access schemes, it generally means that you can start capturing this data much earlier and easier. You can effectively do a trial of 1, react make any changes, +1 more, react make any changes. This drastically reduces your risk and cost WHEN you do your trials (as you still need to do them). - but you already have done that trial and error so that when you do come to do the expensive trial you 'roughly' already know what works.

As an example, we are in phase 3 for EMD-RX5 which is a size of ~300. Now we know that this is never going to be enough, you need to get up into the 1000s when you move into phase 4 (its really subjective here on what the TGA/FDA wants and for what condition, e.g. some conditions only have 100 people in the world - so you can't ask for 1000s).

So back to our phase 3, we complete a trial of 300, but we also have a RWD set that has 8000+ and we are able to provide the tga/fda a continual feed of data so that we can monitor and react. it's like saying we have a trial of 300 every month. - but it doesn't cost us!!! they pay us!!! through our clinics.

note we will never prescribe our own products due to ethical concerns (most companies have written off their data as being non-compliant as they are prescriber and drug developer) -, once approved you will not get it through our clinics you will need to go to regular dr/pharmacy. the clinics really are for the special access and exploration. this again benefits our ability to patent our MDMA/Cannabis synthetic analogs.