Yep...all for it...discussions on PAR with many various and broad thinking parties always brings up interesting ideas and view points.
The brisk walk will also be good to keep our respective cartilages hydrated and nourished!
...and that can only be a good thing.
Yeah that carry on is full of me PAR notes and peer reviewed papers...In actuality I don't dwell too much on the distant future, but I have a great feeling it will one day work out..I also know how much work there is still left to do and the many indications we can one day address. I also know that its been usually SLOWER than we think BUT at the same time, I do think once this gains traction, it will be a lot FASTER than we think...the example is our progression from circa $2 to $4.50 odd back a few years ago, that was quick....
We have so so much more quality data since those days, we have progressed so much, our base is much stronger due to the construction of all the required and insightful programs...
Most companies, as I have said in the past would only do one strain of MPS...who does two? They decided to tackle ERT AND simultaneously Bone Marrow Transplant in combo with iPPS. Yes this added literally YEARS....two programs spanning two different countries ALL WHILE OUR STAFF COUNT IS LOW AND MONEY IS LOW....
This is risk. But what a potential payoff.
Oh this is such a boring race, when will PAR even make the finish line....but I ask you, who wins.....who won the above race? Yeah its boring...yeah its slow....but what's at stake? Are we just going for a small insignificant slice of a given medical market? I also ask you, any of you...give me the pain stats. How many are in pain right now in the world, how many will pay for a safe, a durable, an effective solution? What is out there now? What rabbits are we up against?
A number of shareholders aren't happy...they see these long arduous programs as too much...too long...too boring...but for those few of us that have the fortitude to wait? What is their opinion.
TWO distinct MPS cohorts combining into one....a Global Deal here would mean so much more revenue potential, this is just ONE example of what PAR is doing in the background.
I cannot tell you how rich the payback could be (my opinions, don't only listen to any one source, DYOR).
How many of the 15,500 shareholders today realise this? How many understand how important this 008 program is, what it means to add DMOAD to our label and indeed the Durability AND the Retreatment Programs? This is layer upon layer into our foundations. Boring for the last few years...boring for now.....We all want that skyscraper and now. You cant build a truly huge multi storied building on feeble foundations. You don't want that, I don't want that.
I understand the execution risk you talk of....I also think we still need to be careful...but I'm also buoyed by the level of planning and strategy that PAR are employing at every step - a classic example was the discussions and feedback we received by the FDA themselves when we went for our PRE IND for OA.
Take a look at just some of the points Paradigm learnt from the Pre IND meeting back in 2020:
So pivotal was this meeting, it set us up for the future, "We received both clarity and certainty"
1 from the FDA. It was one of the best meetings that our CMO has attended to despite having some 20 plus IND's during her career so far. It was a view shared by the infamous Dr David Felson who up until that point had worked on the other side of the boardroom table (working for the FDA)....this was the first time he had EVER represented a company TO the FDA.
They got their endpoints approved. ("That is Gold").
They got very few questions about the safety and efficacy of the data presented so far, they new they were the on the right track going forward into the P3.
They also had discussions of the molecule itself and the IP proposition. The FDA acknowledged other PPS from different manufactures can have different range of moieties and MW and PAR's product needs to be identical in terms of both structurally purity and it must be tracible back to the Bene PPS material. That is important to support both the IND and the NDA.
Each batch and the GPC trace which demonstrates the range of moieties (separate chemical structure within the overall structure within PPS). must be shown.
In terms of generic competition, there is no generic for this in the United States. Other manufacturers have different product and thus result in different safety and efficacy profiles. It would be very difficult for another manufacturer to bring forward a generic. It would be incredibly different, it would have to be identical.
This gives Paradigm at least 10 years of no competition in the generic space.
The Pill format (Janssen- division of J&J hasn't been able to be copied so far despite it being off patent for more than 10 years.
Duration was discussed. The FDA asked PAR what they think the duration is, Paul responded that is around 12 months plus. It was here that Par got the clue that the FDA said that to get duration on the label that reflected those results, a separate study should be set up for this. Thus 006 and 007 durability studies were born. This was not a requirement to make the overall P3 successful, but this has reimbursement and labelling ramifications.
The durability will come into play with the Doctors , they will read the label, the notes and the directives from the respective medical associations to guide them on how effective and how long the product will typically last for, the retreatment cycle. This, in my views will create some really incredible excitement amongst Doctors and patients when it is available for sale. There has been nothing for OA sufferers that matches our safety profile and durability.
Marketing ramifications derived from PGIC results. This is a growing area and will positively influence eventual penetration rates in the market.
DYOR
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