his will be my last major post for the year.
But what topic do we cover for the last post? Will it be science related...will it be on competition, perhaps another comparison with PAR? Perhaps we talk about the business side of the company or the exciting future market potential?
I know you, you have just discovered the Pentosan story, you came across PAR but you want more...but not sure on how to get immediate and bulk research to digest over the festive break? You hit the right thread!
Easy to access, no searching involved, just left click on the hyper links at the end of this post, select the best topic for you or hey, try them all!!
I normally do this every 6 months but this year was extra busy so never really got around to it at the end of June.
MOZZ's FAVE POSTS FROM THE YEAR Two of the outstanding posts that were so much fun to write up have to be:
Rescue Me and...
Stairway to Heaven (Single left click the above hyper links to view)
I cannot tell you here and now how many times I listened to that song after I posted it. Goose bumps up the spine? You bet.
If you haven't heard this song, you need to listen till the very end, it starts off slow...but the song is rated as one of the best ever for a reason, stick with it till the end.
VIDEO What amazing lyrics, but so so applicable to us, just one example:
Yes, there are two paths you can go by, but in the long run. 008...they were on a winning course...but no, they changed it mid-stream! They added time, they added a pause while they submitted their revised protocols and pursued Ethics approvals...they endured additional costs...and they added hurdles...
WHY...why add
more hurdles....it is this long term thinking they pragmatically implemented to change the bright path they were already on to make it still more stellar for the future.
1) They added 12 months
2) They added a second site
3) They added 1 week dosing regime
They didn't do the above as a random exercise to make life harder for all of us. They did all of that for a definite reason.
This is the company profile I want.
This is the company I want to invest in. Invest is a operative word.
(My views, not advice, just cos it may suit me, doesn't mean its a natural fit for you, must DYOR to your own satisfaction)
With
Rescue Me , one of my ultimate highlights was constructing this graph for you guys...remember the data is simply illustrative but one day I hope to glean it from PAR...I would love to know how close I got!
Here is the chart reproduced from the post:
(Single left click the above image to enlarge) THANK YOU Thanks to Simon White at Paradigm. You have a large list of roles at PAR and therefore are very flat out. Thank you for the excellent job you do.
Thanks to the PAR staff and of course a huge thanks to Paul...and your direction and the sheer long term thinking will really, really make us an incredible company one day. You took a punt all those years ago and you have been adaptive. Certainly this stock, this play, isn't for everyone, I get that. While it can and is traded on a short term basis, it really is structured for the long term investor, they stand, in my opinion, to garner and gain the most out of this story.
Thanks to my close PAR buds, you know who you all are. It is the excellent research and debates and discussions we have on a nearly daily basis that keeps our fire burning ever so brightly. I value your thoughts and look forward to our next convo, day or night.
A big thanks to
you dear reader. Thanks for your support and your super feedback, it certainly motivates me to keep writing and sharing. If you don't read and provide constructive feedback I wouldn't be posting. Simple.
PLANS FOR NEXT YEAR I must say a few words on next year. Do we all know wat exactly is coming?
A lot!
CONFERENCES There are many, a few off the top of my head.
JP MORGAN - San Fran
LYSOSOLMAL - Sydney
OARSI - Denver
WORLD CONGRESS ON OSTEOPOROSIS, OSTEOARTHRITIS AND MUSCULOSKELETAL DISEASES - Barcelona
(See this link: https://www.wco-iof-esceo.org/ ) These are the ones I know about.They are big, they will mean a lot more to us next year than the other previous years...why?
Our data will shine....more new investors will hear about us and start to take notice. As each month passes we draw nearer my friends.
008 Oh what a program, we got a nice snippet at interim...but wait for 6 month and 12 month!
A few points here just on 008 alone
Canine, yeah yeah Mozz we heard about it at interim., True we did, but now we get the full 20 week data set this translates to three full human years, what an insight! Not sure on the granularity of data but even high levels comments will be most welcome. Further separation of data, and I really do think it will separate more, between placebo and active...watch out! (See below!) Further Bio chemical marker data, again not sure what will get released and what will be held back for a peer review. but could be more insightful at 6 months. Structural, the grand mummy/daddy of them all. What is showing on MRI...or more to the point,,.what isn't. What's happening with BMEL Grade, Vol and Area...what is happening in terms of JSW. Mate this data could be truly pivotal and I suspect it wont just be our keen eyes on it...I think many will be watching...many new prospective investors and some potential partners too. But what could be more exciting than point 4 above?
All of the above!
Huh?
I mean as a result of 008 6 month, PAR have suggested that the next step here will be to hold discussions with the FDA. What exactly will be the result of this? Very interesting. Can you just imagine the convo. that PAR are going to have with the authorities? It will be so wonderful for them to present multiple facets of data spanning biochemical and structural, yes I'm potentially talking early observations of corrective morphology (spec statement) and pathophysiology, in a relative short time. The power of iPPS. All with a Gold safety standard firmly and consistently in place.
Mate.
Before I go on to the next few sub titles...I want to spend a sec again illustrating point 2) above, separation, take a look at this chart:
This is what I'm expecting...
A) Is our Interim (56 day top line read out) for 008,
B) is 6 month,
C) is 12 months as an example, I've drawn the black vertical lines of separation between the cohorts (not actual data)..this is the separation between placebo and active (1 week and 2 week dosing).
Now take out a measuring tape, ok ruler, ok digital calliper and measure those black lines, which one is the longest? Yep..6 month and 12 months,
this is what will be telling...the separation between active and placebo.
This is what excites me.
002 Next year by end of 1st half we will get Minimal effective dosing. It is this that will take us forward into part II of 002 and for all the other subsequent studies. Top line 002 should also come out and a general update at some stage.
006 We have already started the extensional study, its happening right now. Would be great to get an update on this program next year.
DSMB Our first report due soon, will also continue next year. How are we progressing?
TGA PAR have also stated that after 008 6 month and possibly after FDA discussions of the said results, a TGA application would be considered, this will be very exciting for us as we can then speculate about how long it might be till we get the chance to sell into Australia.
A FASTER PATHWAY AA anyone? I will have a special post on this at some stage next year. We'll cover the nuts and bolts of it and the possible mechanism, plays and how it just might translate to you and me. Ensure you are ready for this chance of a real sprint!
SURPRISES ? There could be a few next year, one could be the real chance of increased discussions in terms of an MPS deal and even possibly the chance of an OA deal? Quite a year indeed.
POSTS From my point of view the big post for next year would definitely have to be an OARSI wrap, it will involve some amount of work from my part but it will be a pleasure to share it with you guys. What transpired, what was exciting, who did I talk to, what did I learn and possibly the most important, who did I convince to take a look at US!
I want reactions, I want to be there at the forefront...I want to be there when news breaks...yes share price is one thing, you know, in my view, it will catch up ...there will be a lag...but to be sitting at the shopping centre and observing all these new customers line up and confirm that our product is wanted, to confirm that our product in demand...that's gold for me.
In terms of posts for next year - I'm planning some nice surprise posts next year, watch this space!
So this will be me over the next three weeks:
I will be having intermittent access to HC over the next 3 weeks thus response times may vary. Rest assure it wont be all just fun in the sun, I do actually have a couple of special PAR related assignments to munch through...plenty of deep (but oh-so fun) research to do over the break. But for me, this research into PAR and iPPS is almost as much fun as that sandy spot on the beach and deep pin drop diving into the ocean off a pier (Ebs, I'm looking at you) !
Without further a do...here is the index for the last 12 months with all my other major posts to date below that following in a separate subsequent post.
I have changed the original headings to make them more poignant to the topic discussed and to index them alphabetically.
(20min delay)