Wow, are there some jittery people out there! I had to do a double take and look for what people we all in a froth about.
All my froth is on the top of my cappuccino.
2H19 - finalize fermentation and purification process development scale-up as independent components.
This is what they have been saying all along and I'm not too particularly fussed (not even a little) that they are planning to Initiate "large-scale" manufacturing within 18 months or so. Personally, I would consider letting them build a facility before I demand they start producing. Kind of a necessary step, eh? Perhaps they will be able to license out the technology and do small, or medium-sized batch with contract manufacturers? There is no point in jumping to conclusions before we know the facts.
BTW, if "large-scale batch" manufacturing is using the same process for insulin, then we are looking at multiple 13,000 litre tanks. That is a seriously large scale!
The switch to a single cannabinoid is smart. I said this before, I think getting one cannabinoid approved then get the next approved and then put them together. It will take longer but it won't change the economics of the therapy. In fact, it will make the trials simpler and with a higher degree of certainty. A single cannabinoid will have a better economic model. Also, there is an opportunity for multiple SKU's.
Fast track status is not in danger. EB is an unmet medical need and it won't change regardless of what therapies are currently in human trials. Any competing therapy will have to be proven for several years AFTER APPROVAL before this medical need is considered "met."
Gene therapy - requires surgery. What are patients expected to do while they await surgery? Suffer? It is more likely that if INM-755, INM-750 and INM-7XX prove to be successful, they will be a therapy for patients awaiting surgery and for areas of the body that are less affected.
Competing programs: alternate therapies are highly desirable for both the patients and the FDA. What will work for one person may not work for another. The world didn't stop at aspirin! We have hundreds of pain killers on the market. This will be no different. The FDA encourages alternate therapies so don't be panicked is a therapy comes out.
There are multiple forms of EB. InMed is looking at EB simplex as a cure and a therapy for all forms of EB. I believe the other "competing" therapy is in trials for Dystrophic EB which is rarer and different in the eyes of the FDA. Either way, the more therapies the better and the game to cure this disease has just started and it will last for years.
Something that needs to be considered is economics. A first to market for a drug is nice but it still needs to be cost-effective. The fact that InMed will be manufacturing cannabinoids at scale for multiple other companies means that there should be an economy of scale in the manufacturing of the drugs. There will be 100's of alternate applications for cannabinoids but perhaps not for other compounds coming on to the market. That means that InMed's economic advantage could make it the dominant player regardless of the efficacy of other therapies. This is a damn good spot to be in.
Time to revenues: IF InMed doesn't choose to license biosynthesis, we are looking at significant revenues in 18-21 months at the launch of the unified "large-scale" production. The short track to revenue still exists. They can license the technology separately or they may be able to start manufacturing with the existing partners separately on something less than "large-scale".
Lost in all of this is the INM-085 making progress. This is a candidate for partnership.
Dilution, schmlution: Will InMed need to raise some more money? Probably. Soon? Not likely. Do I care? Not really. I don't think it will put much of a dent in the potential upside. It won't happen for a while and not before the IR team presses the marketing button. I am going to make a bold prediction: the next round of financing will happen at or above US$7 and it will involve the Nasdaq and it will happen in late 2020.
Oh, yeah. Wasn't there some talk about a patent? If you have any doubt, print out the opinion section where the reviewer says 47/50 claims have industrial applications and 45/50 are novel. It covers both Cannabinoids and Terpenes.
I see a castle surrounded by a moat and high fortified walls. And if you look from the outside, you will see a bunch of happy investors on the inside having a party.
IMLFF
