Presentation today. My notes. Not complete. DYOR etc etc and I apologise for grammar etc. I've got to say, I've never seen Paul so confident and excited. This looks as promising as a time as I can remember and I go back as far as patches for insulin!!!
Phase 3
In the last three years, everything keeps opening up. Looks like a good year ahead.
Ignite equity
Lots of interest.
Shaun and I are looking for where they invest a small amount to achieve a high probability of success. Risk and Reward. Milestones, Timing with a real catalyst. They are very excited to invest. They believe the market is significantly undervaluing the company.
The Trials – Timing
Phase 3 clinical trial – already commenced manufacturing. Full GMP.
Locally getting sites up to scratch with IT.
Dosing in Q1.
Recruitment in late January.
Interim analysis – will give a good idea of statistical analysis. Expected in Sept or Oct. The recruitment and screening of patients will make it happen earlier or later.
Stats are insomnia affects 40% of people, and it is growing. Melatonin doesn’t work too well or Restovit gives you a chemical hangover.
Why have other companies struggled?
They are Medicinal Cannabis companies who are experts in growing. We are biotech. We have used FDA and European guidelines. And learnt the do’s and don’ts. The placebo effect is the big issue. When patients are asked how they feel, the placebo effect is increased.
On our placebo, we will get people to say they feel better. The first two medicinal cannabis studies failed in this area. Both placebo and medicine groups improved at the same rate.
Avecho has built a whole range of mechanisms to counter this.
We have learnt nothing from the other trials. But the last result has validated our decisions. BOD announced their trial results and essentially used CBD capsules and failed the primary endpoint. They found that 50 mg cbd was no different, while 100mg was statistically different to the placebo.
We have 33% more drugs than they used.
The second thing they established, the reason they failed, is they didn’t have enough patients. They had 200 which is our interim results have the same amount and we will have over double the number.
Interim Analysis
Is a big milestone. It has two main things. Futility assessment. Specific for this study this is a world first and it enables us to do a powering. How many people do we need to get statistical significant.
It is more interesting in terms of licensing. They had offers before phase 3. They weren’t commensurate. Pharma seems to want to commit to interim analysis point.
With BOD failing, the discussions may happen earlier.
Not many phase 3 10 million market factor.
Why? Share price so poor
We lost a big legal case 2018-2019 and have been trying to build since. Last year we didn’t have regular news to build the case. We were building the trial.
A lot of people discount cannabis. Paul’s job is to differentiate
Fully funded to interim. Has it been delayed?
The interim was meant to be June but it got delayed due to the capital raise. So they cut out some clinical trial sites. They were going to run 10 but down to 5.
Can you give any update on recreational
Yes for sure. Consumer Recreational space is interesting as people get high quicker and higher longer. The gummies were built earlier this year. There is a lot of interest. He visited a number of larger companies. He expects that they could be ….
Topical CBD CBG – phase 2 trials
Oral CBD – clinical trials
Non cannaboid – topical ibuprofen
Arthur Group
Other groups.
Why are you confident that your product will besuccessful where others fail?
The reason is that around the world cannabis has been legalised. So clinical trials have been not a priority. Larger pharma companies have been hesitant due to legal issues.
TGA hates medicinal cannabis. No one did the work here in Oz. So TGA offered over-the-counter medicine to those who did clinical trials. 5-6 companies jumped in, big pharma is setting up cannabis divisions in Asia pacific.
No CBD-registered products for sleep. Millions and millions are using it but not prescribed.
TPM. Increase the dose. Is it complicated in that itcreates a higher dose than prescribed.
No, we have to account for it. Where it is not an issue but an advantage. Is that it may act like 300mg to someone else's 150mg. TGA offered this as 150 mg maximum. That creates a safety barrier.
Epidilex story. Did safety trials up to 6 grams per day. So ours is
Are the big pharma looking at trials.
Yes, they are. Most are cannabinoid curious. Most are evaluating if they will be true pharmaceuticals. Dr Reddy. Halyon – GSK_ made a deal with CANN but Cann failed. Tether. Jazz which acquired GW Pharma. And a bunch below them.
We succeeded in licensing deal is massive overseas.
(20min delay)