ar has always been top of class when it comes to the science, setting up complex and telling trials, having a longer term approach and really making a solid base for a huge eventual platform of possible future wealth creation for us long term holders.
Its in no way an ordinary short term acting and thinking company from this respect.
Sure I cannot stand here and ignore some of the, well, more interesting low lights we have had on our journey. I cannot say that it wouldn't have been nice to have some things done in other ways in the past.
What has happened has indeed, happened.
Par needs to learn from this and be clear and focused, just like they are from a clinical point of view.
But tonight I want to concentrate on another positive, one that you may not be aware of and gives a little more insight into what you are holding and why the future, despite some hurdles we have endured to date, still looks bright in my view.
Please enjoy.
THE LEADING LADY
The FDA realise that there needs to be a template set up in the realm of investigating OA. OA is such a massive disease not only affecting so many millions but it is growing at a fast clip. Don't for an instant think (if you are new to us!!) that this is some older persons disease and I'll deal with it when I get old. Nah it affects younger people too.
Injuries are one of the ways it can affect a younger cohort. But as the population gets more obese, it adds load to not only your joints, but on our hospital and medical systems too. It affects Government budgets and the burden on society. It also leads to many co-morbidities and yet, there is no viable solution.
So the FDA charged a lady with leading a group to investigate what are the tests, what are the biomarkers. Let me now introduce her to you for the very first time.
Dr Virginia Kraus.
Dr Virginia Byers Kraus, MD, PhD
I could have come up with an alternative title for this post, if I did, I probably would have called it the Second Good Doctor. Yes, I hold her in high regard, up there with the great Dr D Felson.
Again, if you are new to us, do click on the following links to get a sense of who Dr Felson is and of course, what is the direct connection to PAR?
POST...............................................................................Published Date
GOOD DOCTOR 1
...............................................................20/11/2019
GOOD DOCTOR 2
...............................................................18/01/2020
GOOD DOCTOR 3
...............................................................14/06/2020
BIO - DATA
Dr Virginia Kraus's credentials read out like a lavish red carpet parade on logies night....
Lets take a quick look:
- Professor of Medicine, Medicine, Rheumatology and Immunology 2010
- Mary Bernheim Distinguished Professor of Medicine, Medicine, Rheumatology and Immunology 2021
- Professor of Pathology, Pathology 2010
- Professor in Orthopaedic Surgery, Orthopaedic Surgery 2015
- Member of Duke Molecular Physiology Institute, Duke Molecular Physiology Institute 2013
- Affiliate of the Duke Regeneration Center, Regeneration Next Initiative 2021
Mate, add on that she was not only Past President of OARSI but she, like Dr David Felson, is a lifetime member.
How many peer review publications has she been involved with?
Well we all know what it must be time for:
QUESTION: How many peer review publications has Dr V. Kraus been involved with?
A) Its going to be a few, 50?
B) 100
C) 300
D) 308 ?
Yes, again all of you are incorrect, its 657.
Mate
As I have said in the past, If I could dedicate the rest of my life FULL time I still think I wouldn't be able to cover off all the research in this vast area. Its like an ocean.
There is so much to read and learn and so much to still uncover!
I need just 15 minutes with this MD and Doctorate...
All I want to do is ask her what she thinks of something like Injectable Pentosan, I would ask her if she thinks this is the best molecule out there for OA that the world has ever seen (I kinda already know the answer to that one), and yes, I would ask for her excitement on a scale of 1 to 10 in terms of our drug and its capabilities. I may actually get this chance at OARSI in Denver in March.
Let me tell you this here and now for the record, if I get this chance, if she is there, If I get my 15 mins...I will report back to you dear reader.
*Whispering* Whaddya reckon? Should I go so far as to suggest we nominate her to our board?
Maybe its a fraction early...lets wait a year?
EXAMPLES OF WORK
Seriously, I don't even know where to begin...All I need you to do is click on this hyperlink and just get a sense of how many and how much research this one leading lady has conducted.
RESEARCH LINK
Just a couple of titles to get a sense of the material:
“The Inflamma-type: a patient phenotype characterized by a dysregulated inflammatory response after lower extremity articular fracture".
“FDA/Arthritis Foundation osteoarthritis drug development workshop recap: Assessment of long-term benefit".
“Intra-Articular Synovial Fluid With Hematoma After Ankle Fracture Promotes Cartilage Damage In Vitro Partially Attenuated by Anti-Inflammatory Agents.”
CHARGED
The FDA are very cognisant of just how many people are affected by OA and how it is growing, but like the yin and the yang, its not just about how the disease is an impost on society...no it goes much beyond this, what is the standard of care?
- Opioids
- Nsaids
- Corticosteroids
All of the above have the problems and all can lead to really nasty and unwanted side affects to say NOTHING of the fact that ALL of those above, are symptomatic only. No mention and no possibility of Disease slowing, arresting and certainly reversing.
So the FDA charged Dr Virginia K (and Dr David Hunter et al.) with the high profile task of coming up with the prognostic biomarkers, biomarkers that are crucial, biomarkers that are telling in this space. She co-headed up the OA Biomarker Consortium. They are in turn charged with which advances the validation and qualification of biomarkers for OA diagnosis, prognosis, and clinical trials.
FINDINGS TO DATE
The consortium led by Dr Virginia and Dr Hunter to date have identified a few biomarkers such as CTXII. In my opinion this one is key as far as determining the progress of OA. Indeed it is very exciting that we aren't just studying one such biomarker, we have a number covered AND we will soon be hearing of structural biomarkers (Q1 6 month 008) and how they perform when treated with iPPS.
We see a number of initial conclusions with more work to go.2
Alzheimer’s Disease has multiple similarities with OA
High prevalence – patients matter Alzheimer’s Disease 5.8 million in US - OA 32.5 million in US
Biomarkers now exist in OA that are “reasonably likely to predict important benefits to patients”.
RELEVANCE?
Yeah great Mozz, really impressed with Dr Kraus's high credentials, her efforts, her awards, lifetime membership of OARSI (and she was a past OARSI president as well) and her being charged with such an exemplary role in determining what biomarkers the FDA should rely on in the field of OA. I'm sure she is going to be an inspiration for a few...
Mr Mozz - How's is it at all relevant to my holding, please tell me why I, as a PAR shareholder, should care at all?
Well here is just another way our company is doing some great work in the background that how many of us actually know about???
We all very easily point figures of blame....but while I agree things aren't always in our favour, there is also some good stuff brewing behind the scenes ...
Possibly the most fascinating observation I can make however, is the following...
(Single left click the above image if it is a bit small).
Do check out reference 1 below to see it for yourself!
Dr Virginia Kraus has a direct relationship with PAR!
-Mozz
DYOR
POST SCRIPT
I have at least two more Mozz Posts in the works featuring the great Dr Virginia Kraus, hope to get them out by the end of this year! One such post will be on the work Dr Kraus has done on Trial Design and how it plays into the possibility of an Accelerated Approval.
REFERENCES
1]
https://scholars.duke.edu/person/vbk
2]
https://www.arthritis.org/getmedia/...03-4d7d51f844f2/Biochemical-Markers-in-OA.pdf
3]
https://fnih.org/our-programs/biomarkers-consortium/programs/progress-oa
(20min delay)