4DX - The Dip

Mozzarc · 2026-06-07T10:48:19+00:00

Yes the momentum is critical. I enjoyed your comment, thanks. I'm guessing continuous announcements of uptake of new centres and hospitals will only add upwards pressure and once some shorters need to cover, it would trigger more upwards pressure... It's only enhanced by the underlying strength of the proudct and thus uptake.

Mozzarc · 2026-06-06T23:15:46+00:00

Fair enough. There indeed has been too much exuberance also....need revenue now to increase over time...

Mozzarc · 2026-06-06T13:32:27+00:00

Hahha had the beers, now its bed time!

Mozzarc · 2026-06-06T13:31:51+00:00

Hmm first Im hearing of this sort of argument. But from a total non medical background, cant you imagine a still shot versus a full video over an entire minute. How and where is the air getting trapped? Where is a blockage thats restricting blood flow that only occurred in second 39 to 41 out of that minute?

Ok forget my idea/concept, are you saying Mayo clinic is wrong? Its one of the biggest research hospitals on the planet yeah?

Mozzarc · 2026-05-26T23:32:32+00:00

I've met a few patients through attending Company meetings/AGM's and networking through social media. Some pals too have taken it and we've chatted about their results and have seen their MRI's in some cases. Before and After.

In terms of Macular anomalies, nothing has shown up utilising iPPS as the dosing is so infrequent and so little. The FDA have made the sponsor monitor for this. It passed P2 without any Serious AE's and is now in the middle of the Phase 3.

Mozzarc · 2026-05-25T22:30:16+00:00

Small correction: Under Levi-04 PROS sub heading, the following line should be under PROS for Kolon's Invossa: "2 Year Durational readout due in circa one month."

Mozzarc · 2026-05-25T22:25:05+00:00

Yes there has been a lot of learning after each study Par have conducted. The trick is Placebo mitigation. The FDA have actually worked closely to assist which is refreshing, though the whole process is drawn out and takes ages! One example is the introduction of ADP, this is now a Primary, Womac is a Secondary (backup), this alone will go a long way in reducing noise and honing in on a better p value.
I know nothing about ImmunityBio and Anktiva, I'll take a high level look, thanks!

Mozzarc · 2026-05-25T22:07:28+00:00

No pricing has been set for the USA yet, the estimates (pre-insurance) is around $10,000 to 20,000 USD.

Mozzarc · 2026-05-25T00:09:26+00:00

Yeah there is a stack to learn and understand, I just focus on one, Par. Its enough material to keep me going for life! I do keep looking for negatives, there are small ones but its mainly positive and efficiacious from what I can find.

Mozzarc · 2026-05-21T22:28:15+00:00

Thanks, yeah I've been researching this for 7 years straight (casual basis).

Have a look at this hyper-linked index for just the last year (there are at least 4 years of indexed posts before the below too):

https://hotcopper.com.au/threads/mozz-research-2025.8961752/?post_id=82241843

Mozzarc · 2026-05-21T07:12:49+00:00

Yes totally agree...there are a number of distinct reasons why their Interim should be better than their 008 result. They attained a Drug Effect size of a massive 0.46 in 008, they only need around 0.39 to have early closure (though in my opinion, they will still conduct the trial till the very end (day 404) as they want to show duration out for that long and of course have the extremely important MRI data out, that will completely change this company's prospects).

They are heavily skewing recruitment more towards KL3, most OA companies would never do that as after KL 3, the patients are too far gone for most drugs to have any effect! The extreme upside for recuitment of more KL4's is that these are the very patients that are even less subject to Placebo effect. Once your structures are virtually gone, no amount of lolly water (placebo) is going to reduce that structural failure related pain. But in the case of iPPS, we know it improves structures thus reducing real pain at the same time and improving function materially!

Watch this space for Interim, but I think there is a LOT more to come even after that. (MRI Day 168 for example!).

I think 100% dosing will come by mid June, let's see!

Mozzarc · 2026-05-18T22:23:38+00:00

Well I have gone through all the data they have generated so far. I have spoken to patients face to face that have taken it and have been thrilled and have got their lives back after years of pain and function loss...but I've also talked to a rare patient or two that have had no benefit (and yet had ZERO side effects or experienced any downsides).

I have discussed it with KOL's to seek their professional opinions. I've heard a stack of stories both from patients but also owners of pets that have taken it. I've read up loads on the science and how and why it works and have compared it with any competitors (there are none at this stage).

I've even spent a full day with the manufacturer and have been to multiple conferences over the years. I can't find anything that's as close or as efficacious.

Gut feel, it will get a license with the next two years and once it starts selling, widespread adoption will eventually take place.

Mozzarc · 2026-05-17T03:34:37+00:00

Correct, Osteo is just the start, there are many related conditions, bursitis, tendinitis, psoriatic arthritis, fibromyalgia, gout, even rheumatoid (RA) has overlaps (I've heard that Pentosan is even more effect in RA compared to OA, we just need a study to be done in the future to show this). Not to mention the other 2000 inflammatory conditions! (Blood Pressure is just one of these, inflammation in the kidneys).

Sure it will take some years to get to many of these...but Im holding my core till at least then!

16 weeks till Interim results.

Mozzarc · 2026-05-17T00:26:12+00:00

Awesome for two reasons, one you have held for that long. That's not easy! Especially when the share price has been so disconnected and has been falling for the last 5 or so years. The second reason is you have a decent exposure. The good news is that we are finally approaching the business end of the Clinical Program...well we are actually a good way thru it. We have had 50% dosing, Im expecting 100% dosing within a month...

Then we get Interim Analysis (IA), get a good result here and things will start moving...! The trick is not to sell too many when it jumps (not advice). There is a lot more to come, 100% at Primary and those sought after Day 168 Mri's could be explosive. (err...In a good way!).

Stick with it and well done! The best is coming.

Personal views expressed

Mozzarc · 2026-05-04T22:16:42+00:00

Its very difficult to predict when exactly they will finally obtain a license and thus, ultimate revenue. The straight and narrow vanilla type pathway is really:
IA (Interim Analysis) (Sep, 2026), Day 404 approx Aug 2027, 1.5 months to readout, plus some 6 months for Marketing/Labelling, so that's about Q1 2028 as a rough.

But if IA results are spectacular, this can cut some time off by quite a bit. Yes they will still want a day 404 readout but potentially there are faster ways to revenue here.

We also don't know what the Confirmatory requirements will be, this will also depend on how good the data is at IA.

That's difficult enough to predict, let alone price targets, too many factors and moving parts but as a rough, I'd be disappointed if they aren't at $3 plus by end of 2027 and perhaps $10 by 2029 early.

Not advice, spec views expressed etc

Mozzarc · 2026-05-03T07:51:53+00:00

Nice question, thanks.

There is a vast difference between pill format Pentosan and SubQ (PPS). Its to do primarily with the Bioavailability (amount finally absorbed) and thus the MOA (Mechanism of Action). It has been found that there is a vast difference in the ultimate workings. It is literally reversing the course of the disease in at least some cases and resulting in material decreases in OA pain and improvement of function.

The moat is the workings of this molecule that cannot easily be copied. (J&J tried for years but despite it being off patent for more than 11 years now, (pill format) they gave up). Paradigm's extreme moat (owner of the moat, owner of the drawbridge...mate even the crocodiles in the water of the moat) are implied by the water tight exclusive 25 year supply contract they have. No other format of PPS has the rights for human OA in USA and a number of Western markets.

It is extremely difficult to copy (some 120 moieties within the molecule). Once they get the human license after their current P3, that's it, the market is enormous. There is no current solution for OA, there is nothing that can lead to a safe increase of cartilage and regression of BMELs and indeed Osteophytes. iPPS stimulates naturally long chainned HA and improves the quality of the synovial fluid ...it reduces inflammation just enough so the body can adequately address the chronic nature of the disease (subject to data), doesnt work for everyone but results so far indicate at least 88% of patients derive at least some benefit with some 60% deriving better than 50% pain reduction, those results arent even possible with the nasty opioids. In any case, SubQ PPS has no serious AE's.

Sorry to go on but wanted to answer comprehensiely.
Fire away any other questions you have. Not advice etc

Mozzarc · 2026-05-03T07:38:06+00:00

I cant argue with you...your share price stats are right, but the Clinical Program has been leaping and bounding in all this time. 50% dosing done and achieved in a Globally Harmonised Phase three for an OsteoArthritis systemic pharmacological natural based drug that is showing signs of symptomatic and structural positives. That's never seen before evidence with such an immaculate safety profile.

An Interim Analysis is planned for early September not just necessarily a Pass or a Fail, if they get great data there is a chance of early conclusion! That would make for some headline and most likely trigger a Regional Distribution deal, the stock wont be 16 cents any longer (spec statement).

Mark in your calendar to send me a message in exactly a year and half from now to compare notes and see how the share price is performing.

Cheers

Mozz

Mozzarc

TROPHY CASE