PART 2 - PASSING THE TEST Ok let's now tackle the second set of filters these guys then use and how it applies to us:
STAGE 2Once Stage 1 is passed the next set of filters goes deeper. Let's investigate:
KOL stands for Key Opinion Leaders.
There are many here. Firstly we have internal experts, our own staff, do they believe in the product, how do they compare it to what they have come across in the past?
Industry Peers, prob best indicated by peer review papers, do we have some? You bet, here is an example, single left click to follow it :
PLOS ONE - Pain and PPSDefinitely worth a read if you can munch through the science, pivotal findings...sets us up for some amazing future potential.
Allow me just one quote from this astounding research conducted by...well, the team at PAR:
"Together, this provides evidence that PPS may act to suppress the release of NGF in the subchondral bone to ameliorate pain associated with knee osteoarthritis."@Burdman, @Superlegend, not sure If I'm a poet...but reading the word "Ameliorate" above, (to make something that was bad or unsatisfactory, better, return to a prior state) is indeed an absolute poetic prose for me.What are industry bodies saying? Are we out in the public domain? Are the analysts slowly getting wind of us?
One of the best examples is JP Morgan. We used to request them to join their yearly conference as a more passive participant. Well not so in 2021...they invited us AND it was for a proper presentational slot. Paradigmers, expect more of this red carpet treatment in the years to come...Sure I wait for the regular exciting news and data like the next shareholder but you know what I am also waiting for? Mate, I'm waiting for those Boutique US Investor funds to start digging into us...start researching us...the Piper Jefferies...Barons, heck even Motley Fool America (the Gardner Bros), Credit Suisse, Jim Cramer (Love him), Cowen to Oppenheimer and there are plenty more...
Have we attracted some good talent to help us? No bigger key industry leader in this field than Dr D Felson in my books. We also have great internal talent like Dr Krishnan, Dr Skerrett, Dr Imperiale and Dr Joughin.Fine Mozz, good to know...what are the frontliners saying?
Yes of course we have heard from the patients. yes glowing testimonials from the professional athletes....but you know what I want...I want a testimonial from one of the treating Doc's...that would be an entire summary...a full wrap of what THEY are observing.... We will revisit this point towards the end of this post...let's for now continue through the filters...
Yes I know pain is subjective, placebo effect and all...Are there other criteria that gives
empirical evidence?Well sure, how about reduction of BMLS...what about demonstrating a reduction of size and volume by MRI for instance?
PAR's April 2019 announcement showing empirical evidence of Grade, Volume and Area of BMLS reducing as a result of the amazing iPPS. Stunning data, and 008 soon will potentially show more DMOAD on top of what's already been seen so far.
If I had a wish for our product in terms of manufacturing, I'd want it to be:
Exceedingly difficult to make.....dang it man, make it so hard and so complex that it would need to be developed not over months and months....nah, not even over years....I would want proprietary tech. and manufacturing made with in-house equipment, specially designed and purpose that was built over
decades...that only our manufacturer is capable of coming up with as they make delicate refinements over the long term.Moieties...molecules within molecules...that need to be precise. I'm talking atoms...I'm talking bonds...I'm talking reactants...I'm talking sulfatisation to the n
th degree.
I would want the process of making my product just so cotton picking SENSITIVE that a wee slight change in temperature at step 43 (Mozz made up example) would change the molecule totally, this is actually what happens.
I want a manufacturing process that is just so darned unique that you get one of them mass spectrometers and run the final product in question and it has an incredibly unique signature, not unlike a fingerprint.
Remember this one? Thats the finger print equivalent...NO other competitor of ours has come close to GMP standards and batch consistency...there is only ONE worldwide FDA recognised supplier....we have the Global exclusive with them.
I'm hoping that once the FDA have actually had time to read through 30,000 pages they realise just how consistent our data actually is... it's a huge win for us already. The fact that we are just so consistent demonstrates how reliable this wonderful product is.
This is what I wish for...this is what is reality. (not my opinion, it's a fact).
Ok good and fine Mozz, what about others, have others tried? You bet, and failed...Elmiron has been off patent for more than 10 years, is there a generic to it? Nope...
Biosimilar? Nope.
Mozz, it's not just about someone NEW coming in to copy, what's the competition out there like with current remedies, current std of care?
You mean destructive NSAIDS?
You mean addictive OPIOIDS?
You means cartilage destroying CORTICOSTEROIDS?
...A house of cards in a Cat 5 cyclone is a statement I could conjure.
STAGE 3Once the analysts have passed a company through stage 2...they then will look at the last round of filtering.
Welcome to stage 3.
Certainly no point in investing in a company that is stalling, that has a low chance of making it, that doesn't have great evidence to date, that lacks experience and or consultants that can help them through. It may be due to lack of funds too or a difficult area they are tackling that can be riddled with AEs or hurdles. A good company will also have a so called Pipeline ...not just one indication they are tackling...but multiples....
Yes this will be our next phase to focus on once we have an IND going and we slowly make our way closer to Read Out and then Registration. What's the plan?It may depend a lot upon our eventual distribution partner....will it be a true symbiotic relationship? Can we both utilise the skills of each other? In many cases a schmick advertising and marketing campaign might be the all important hinge, I have a feeling our results, our efficacy and our first time DMOAD data may just speak for itself. Word of mouth also is going to be a huge boon for us.
Well this is going to be very much up to the individual, If I took a survey of 500 Hot Coperians I might get close to 100 or more different strategies and a lot wouldn't necessarily be bad plans at all.
A tip (not advice), is to have a plan before the action....when things are going from strength to strength, it's easy to get carried away in the heat. Write a plan down...stick to it....sure re-evaluate as we go along....but even if its a % of holdings...it makes a lot of sense to do this....sure it becomes more pertinent for traders, to take that emotion away, the best plans are to automate...triggers....no emotions involved, it just happens.
For a longer term holder like me, my plan is fairly simple, I might trim a little at a certain point, but the core, I'm not touching it unless something really changes...it might be management change if it can't easily be explained...it might be some exogenous event....it would have to be fairly drastic...always ask questions along the way.
So always have a :
Always have a BABY? What?
No no silly! Always have an ear to the ground.....!! (What were you thinking?)
There are other criteria that also must be met, some of which might be unique to us...think supplier agreement, think of the ability to copy us, our history, and of course our runway, our TAM.Each of us must also use our own criteria to assess what we have and our own time horizon, risk profile and ability (Nerves of steel?) to Hold Hold Hold (Thanks
@rusty388, a poster that used to follow us diligently, been too long since I have heard from him)...I hope he still has his lot in PAR.
So why didn't I do it?
Do what?
Why didn't I sell out at 4X?
Oh thats easy, it's the RAW potential that keeps me going. When...if.... it dries up..that's when you will hear from me less. I reckon (just my humble views) we will start to slow down after Peak OA sales...but even that ain't true cos we have a few indications within the iPPS realm up our sleeves...needless to mention any other repurposed drug suite we may obtain??
Ok enough from me....here's a quote from someone else ...
"Given a 10% chance of a 100 times payoff, you should take that bet every time."Who said that?
Jeff Bezos.
But can we actually get to 100 times pay off from here?
Don't we have to all invest in at $0.35 to achieve such lofty figures? Not so, in my opinion.
It is entirely possible right from here, I could even venture and say it's probable that we might one day get that 100 X from here. It's not going to be next month or next year...but it could actually happen once this thing takes off in X years time.Don't forget Humira...one tenth our TAM (RA) just looking at OA...they achieved $19 Billion USD sales within 16 years...65% market penetration....if we match their results in half the time (entirely possible considering our market size is
10 times theirs) it could be just 8 years from first sales we achieve those figures, that would theoretically easily put us at $200 a share even with a little more dilution.
@ceviche, your thoughts?
Ok I have made you wait enough....
THE MOZZ BONUSAs I said before, I value the theory...the science....but the science is in labs...finally it is the Patient impressions that mean a lot....but what's better than a
single patient's testimony?
Here is a testimonial from one of the SAS Treating Docs....incredible read.
....Do enjoy this tasty morsel, read till the very end:
‘’We were all very skeptical at the start, nothing can work like that! There was a limited take-up to begin with, but as word of mouth reports started coming through prior to official results, everyone started getting on board, we were hearing up to, and possibly more than six months pain relief for two thirds or more of patients, clearly this was no placebo.
We had no idea at the time as to reasons why, but started looking further to understand. There is large cohort of patients who are past the treatment of arthroscopy, but are not ready for a knee replacement, it’s this group of sufferers which is huge, and stand to benefit from PPS.
I will be very surprised if the product doesn’t hit the market with a bang, given what we have seen in phase 2 studies. PPS is a unique product, what it does in the joint is like nothing we have seen before, it alters the biochemistry for the good, we are starting to believe that PPS improves the joint, which nothing has ever done before.
PPS can potentially fill a massive black hole, and overall I am very excited to see what it can do. As a shareholder I am excited of course, but as a doctor equally as excited, as it gives us a more reliable product than anything we currently have at our disposal. There is a crying need for an acceptable alternative, which is evident in the opioid crisis. Sufferers are in desperate need of an alternative, if it’s shown to work, and is cost effective, there will be huge demand for it. Alternate products we use currently are A$475 for a single injection, which patients can have every eight months, however these treatments have very limited efficacy."
Doctor R. Patterson
South Australia
Let me assure you, I've read the above extract at least four separate times, I'll be reading it again a few more times over the next few years.
There are some profound gem statements in that one quote.
My views
DYOR as per usual.
Yeah, it's still a 'Buy' from me.
(20min delay)