Botanix The company started very early on with trials following along the traditional drug development path. They use a single synthetic compound of CBD in their products which regulatory bodies prefer. (Actually side note: I was listening to a podcast on compounding products and how there are so few FDA/TGA approved). Synthetic is always preferred because of its purity and likely scaleable. - nature mutates and it's hard to give that 99.999% confidence.
Matt Callahan is one of the few experienced pharmaceutical experts here in Australia and has a number of drugs taken through FDA approval. So hard to get anyone better. And speaking of the rest of the board top-notch experts that are paid to deliver. He is also an IP lawyer which is where all the value lies in these companies.
I think retail investors were too harsh with the results and they were miss understood, remember if you wanted to start the trial 3/4 years ago there were processes in place that had to be done in the USA - and the involvement of the DEA and batches produced per state. That's what you had to do there was no mess up when if you make the decision to do the trial you also have to follow the regulatory framework in place. - Remember how early Botanix is doing these trials compared to others. If these trials were to be done again it would be different, the DEA has now signed off on the synthetic CBD and doing the trials again would be slightly different. who knows maybe the same as Australia which HC call a fail but the FDA call ok we understand looks safe and you got something continues. - so go figure.
Zelira Zelira interest me because it was investigating what most people seemed to talk about anecdotally - pain and sleep. Mara Gorden who has a background in IT started Aunt Zelda and captured a lot of informal data for the patients they were treating in California and created a data capture system. This is likely the first informal real-world data (RWD) capture and likely reduced somewhat their clinical trial risk. Mara continues to be a leading advocate in cannabis drug development.
Zelira then merged with their USA based arm and this instantly got me excited because we started talking about launching products today and gaining real-world feedback. - they call it launch learn develop. - I work on large IT projects (30million - 5 years or so) so I understand a bit about long projects and long timeframes. As a consultant as an expert, you pay me not to turn it on at the end of year 5, (like the traditional drug development) but to turn it on as fast as possible so that you can start getting early benefits realisation, a return on investment today and for continues improvement via RWD.
Zelira is really the first that understood that actually, you don't have to wait to make a $ and that cannabis drug development is unique in that we have a SAS model.
IMO I do not yet believe that any of the large pharma companies have yet worked out that you can launch your product today without the trials and start earning a $.
When you bring in a continuous improvement framework you will quickly outpace your competition and in this regard, a number of these companies could all overtake GW. - remember GW targeted a pretty specific condition, where sleep pain affects us all. pain and sleep are also the common side effects of many many other conditions - it's like an all in one.
Emerald Now we are getting somewhere with the RWD, if you don't follow the FDA end 2018/2019 Principal Deputy Commissioner of Food and Drugs highlighted that RWD is of increased importance and a number of documents came out about RWD etc etc.
Emerald was spun up by Steward washer (Zelira and AC8) and Matt Callahan - if one remembers when Matt took leave from BOT then emerald IPOd and matt was back at BOT. My take is that he looks some time away from BOT for 6 months to spin up EMD's clinics and RWD capture model. We already have EMD and ZLD working together - I'm almost waiting to see if EMD find anything interesting around skin in their RWD and if they do will they partner with BOT?
Speaking of RWD if you want to use it alongside traditional trail results you need to do it property and I think EMD is the only one capturing the data in a verified system. they claim to now have the largest cannabis data set. and within 12-18 months have now found some good insights and are now spinning out two products.
IHL This is a new entry for me, I looked into them when they were doing mouth guards and it wasn't my thing. I didn't get or understand the value in what they were trying to do and I crossed them off my list for a year. However, within that year they pivoted and are now a completely different company.
Mouthguards to cannabis blink and you almost miss it.
They have a good value add model set up. Cannvalate (private) for instant launch products out there gives you your ROI today. you 'go live and trial it out' and then design your value add model of clinical trials and drug development with reduced risk. Revenue is a biggie on this one along with their phase 2 assets. Could be up to $1M this Q and that likely puts them #2 behind GW.
Market capsIHL and EMD as new entries are both undervalued. IHL the most blink and you miss it. and I think that EMD is undervalued as people don't yet understand the real-world data capture model and the compounding effects that it has long term. However, at this stage, I don't think its which one will do the best when all are in the top 5 global cannabis drug development companies and there is no better place to do the research with that sweet 43% rebate and the lovely SAS model.
All will likely be undervalued until that big deal with big pharma for a phase 3/4 only then will the rest of the globe wake up. Again BOT might be the best case here again with their relationships and they have Cowen in their backing.
TGA/FDA approval I'm not expecting any approvals for another couple of years (4?)
phase 3s are costly to run. Most of the market caps are lower than the cost of phase 3 let alone have the cash to do it. Botanix so far has prob the best relationship access to get a third party to pay for them.
