The Good Doctor - Part 3

THE GOOD DOCTOR - PART 3

made a mistake, this series should not be titled Good Doc...it should be called GREAT Doc.

He has a book. What? I only just stumbled over it last week....mate, I don’t have the bandwidth to read it though I should. All I can hope to do is give you guys mere snippets of it. The snippets are like pure gold veins in a rock face....Somewhat like a miner digging for gold, we need good quality implements to extract out and understand the gems that Dr Felson covers…. NO wonder he is an OA World Authority. I can't believe what a coup it is to have him bat for us and for the first time in his long long career. (Can you just feel my excitement ring through these posts, do you guys know what you own, what it is capable of and what the future could be?).



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_{A pure vein of gold? This is what we have in terms of the Great Dr D Felson, what a find!}

BRIEF RECAP

The Great Doc has published heaps of amazing articles on OA. As stated in a post last year, I could dedicate all my future posts JUST covering what he has to say about this complex field and trying to interpret it in Mozz speak. Mozz speak has to be one of the simplest forms (so that I can understand it!!).

The Great Doc for the very first time in his life, went with us to the FDA. Why? To help us present our case. He has NEVER done this with ANY other company. Paradigmers, such was his conviction of what we have. Dr Felson has appeared on the FDA board before…evaluating companies as they present their case to the FDA with their clinical trials, this time he is on the other side of the table, representing us!



_{Wait a sec, Did the Great Dr Felson just switch sides for us? Going from the FDA interviewing panel to our side, PAR putting a big case forward and he helping us to explain what we have to the FDA?}


Now Paul said in the last PAR (Audio) on the 7th of April ¹ that Dr Felson along with Dr Donna Skerrett our CMO felt that this was the best meeting they had both attended with the FDA. Donna has attended between 20 and 30 FDA meetings representing other companies she has worked with. It is these little clues that new Investors…that outsiders can simply fail to miss. If Dr Felson finds something compelling enough for the very first time to go to the FDA and explain to them what we have, why it’s compelling and why the FDA need to take this seriously, it’s enough for me. If someone at such a level like Dr Skerrett also states something like this was the best meeting that she has attended with the FDA....well...you pick up what Im putting down right? In fact this one statement trumps a lot of MOZZ research. These subtle actions and one line statements are clues for us.


THE BOOK


_{As I said, I don’t have time to read through the entire book but I reckon it would have more than just a gem or two…}


Tonight, I present just a skim while flipping through it: Dr David Felson postulates and wonders why, in previous articles, in previous research, the association of pain and OA hasn't been explored to a deeper extent? He states that pain is the number one driving factor causing a patient to finally see a doc. He then provides a possible solution to his questioning:

"By the time a person has clinical osteoarthritis, his/her joints has probably experienced longstanding cartilage wear, bony remodelling, perhaps modest synovial inflammation and a weakness in bridging muscles".

He is telling us that by the time we really are in pain, the damage has well and truly been done.He wrote this book back in 2009...he did not know about iPPS then...he went on to write:

"Our ability to reverse this pathology [Osteoarthrisits] and create a healthier painless joint may be limited".

What would he say now that he knows of PAR? Well the answer to that question is the fact that he has gone before the FDA with us. He goes on to say that in normal cases, pain is an alert, it tells us to throttle back on our activities, but in the case of OA for many patients with this disease it may be 'the source of their most severe, troublesome pain, pain that is the most disabling and causes the most problems with their daily functioning". No wonder the FDA has kept and made the Primary Endpoint for the entire of our success in Phase three to the measure of PAIN.

Paradigmers, in effect the Great Doc was also telling us future investors (i.e. Us Paradigm investors now) that if there is something that actually alleviates this very same pain, and does it safely, it is going to be big. It's going to be sought after...it’s going to be valuable.

Dr Felson then goes on to state that OA is complex. It involves a "multidisclipinary" approach... he then mentions some of these. Again as I have also mentioned earlier in this post, each point below could be a separate Mozz post. The more I think about it, the more I realise how people suffer.


1) NEUROSCIENCE

2) JOINT ANATOMY

3) JOINT PHYSIOLOGY

4) PERIPHERAL NERVOUS SYSTEM

5) AUGMENTATION OF PAIN MESSAGES

6) FOCAL LOADING AND SUBSEQUENT DAMAGE TO JOINT STRUCTURES

7) STIMULATION OF NOCICEPTIVE FIBRES


Incidentally from the above points it's interesting that our MOA that was explained by our CSO is heavily tied in specially with points 4 and 5. It was a real discovery, a breakthrough for the first time in the world, to realise the role of NGF and this one action has many interesting and revolutionary impacts for us. The realm of pain we have certainly touched on in the past, there is so much more to come in this area alone.

Paradigmers, I do not protest that OA is not large, but Pain is like the vast ocean, it affects many. Estimates run at around 20% of the population. ² As we have seen, Zilosul is not a mere pain blocker, this is not a Panadol for the cells under duress. A pain blocker will not stop the underlying rot. It will just trick your brain into thinking all is ok...your cartilage will continue to deplete... You cannot simply band aid over the damage, block the pain to the brain and say all good. The actions of iPPS is to REDUCE and PROTECT the cartilage from progressive degradation.

The world has not had a DMOAD before. This fundamentally involves NGF. What and how it is relevant to us and MORE about our breakthrough in this area and why Mozz gets excited because this story ISN'T just about OA, it’s about the enormous area of pain, can be seen in the link in the next paragraph.

Are you a new investor to us, did you buy your first parcel of shares just a month or two ago?Read this about NGF and you will start to understand what the action of our drug is at a micro biological level. LINK ----> NGF EXPLAINED


The book goes on to explore pain from OA. As part of the prologue for the book the Great Dr pays homage to his dad and quotes this:

"I appreciate the forbearance of my wife.....and my father who taught me to welcome and be excited by new approaches to difficult problems".

No doubt OA is a difficult problem, a problem society has had for decades...a problem that grows bigger year on year and a problem to this date that does not have a viable and safe solution…Dr Felson approaching the FDA on our behalf, is an effort and an action he hasn’t ever done before. This is a hint for us.

Paradigmers, OA has haunted society for how many years? It has taken amazing technologies such as MRI to really discover what is involved, they have made many discoveries along the way not limited to the fact that OA is not in one spot (It involves the entire joint), OA can start early (It's not just an old person's disease), joint injuries can result in some 50% of a chance of developing OA and so many more discoveries have been made. As Paul Rennie quoted, Dr D Felson is very excited by what PAR has and this is evidenced by the fact for the very first time ever in his career he has gone to the FDA himself, representing a company (PAR) to tell them and explain to them what we have. No wonder the Pre IND went so well....let's see how the IND goes later in the year.

There's so more to come.


DYOR



REFERENCES

1)https://paradigmbiopharma.com/investors/presentations/

2) https://www.cdc.gov/mmwr/volumes/67/wr/mm6736a2.htm#:~:text=An%20estimated%2020.4%25%20(50.0%20million,adults%2C%20adults%20living%20in%20poverty%2C