*Whew* busy day, good day.
Here are a few of my day's thoughts...
Probably one of the most outstanding remarks from today was the fact that we achieved
statistical significance...not from thousands not from hundreds...from 20. Yeah just 20.
This study is telling me that there is a definite link going on, yeah we expected it, but so nice to see it...think we are going to see a lot more yummy data and observations again in the 6 month readout.
Along with much more data , we may see or read something like this:
KEY:
RED - 2 weekly dose
BLUE - 1 Weekly Dose
GREEN - Placebo
A = 56 Day
B = 6 Month
C = 12 Month read out
You can see the black vertical lines as separation lines....as the study progresses, we could observe more separation. This is possible in the context of things like Rescue Medication. This is the kinda data set that PAR may see at 6 months and at 12 months and will add real weight to our current observations. Imagine this sort of exponential decay with biomarkers too. As the study progresses, the data separation may be increased.
I do look forward to 6 months, and another little thing I like is that 6 month readout may only be 4 months from now!
STATSIn the FiftyOne Capital interview back in March 2021 (See reference 2 below if you haven't seen it, its long but worth it) at about the 55 min mark Scott talks about the 008 trial along with Paul. Scott proclaims that the numbers are small but...
"God forbid if you actually hit a statistical significance result in this, it would be a pretty clear look-through from a Phase 3 outlook".
Well....it hit it.
PROGRESSIONHow many of you saw that little gem of progression - yeah I'm talking figures, let me get specific.
Back on 22nd of June this year Torpy reminds us of the progression of great data and how it literally appears PAR are learning as time progresses
3:
Paradigmers, what did PAR release today?
Mate, how does the above compare with opioids? Its only a general comparison...but it gives you an indication, opioids in general are said to reduce pain by about 25 -30% or so:
"For example, a review of 15 double-blind, randomized placebo-controlled trials reported a mean decrease in pain intensity of approximately 30% and a drop-out rate of 56% only three of eight studies that assessed functional disturbance found improvement".4Another study summarised their findings in the below chart
5:
Above Chart - Ref 4
Just compare that with our data. Opioids kills some 112 Americans every day. As Scott also said in his interview a year and a bit ago, the statistical bands will tighten up with a larger study such as our Phase 3. Things can literally only get better for us from here...
ACCELERATIONI have a number of posts scattered through HC over time regarding my thoughts on AA. I'm wary of getting too carried away too quickly. My own research does show a very clear pathway to the holy grail of AA. There are fairly clear indicators of what is required and indeed what we are capable of.
A number of ducks are required to line up would include , but not perhaps limited to:
6 Month data - 008 and great progression of our surrogate biomarkers (yeah that was plural)
Top Line 002
DSMB reports with excellent safety observations intact
Min effective dosing determination
Consistent data release from here on in
Get those 5 ducks above aligned....you have a serious case.
Now add in a Mozz special of not one, but several surrogate biomarkers, and to further boost our case, turbo charge it...add biomarkers from MULTIPLE BIPED groups...add a little structural data and you have a winning formula...so winning that there hasn't
ever been a drug like this in this realm of immunology and inflammation leave aside safety profile, durability of effect, effective reduction of pain and increase of function. Our time is coming (spec statement, though perhaps getting less spec these days and in future days?).
Yes I believe PAR would be seriously putting work together to form a case of AA once and if we have all those ducks lined up neatly...
The thing I like is that I sit here today and imagine, just imagine that STILL not many know about us! Isn't that fascinating. I believe PAR has learnt a stack from prior trials and results....not just what Torpy indicated in his post. I'm talking about HOW to release data, WHEN to release data and in what format.
COPPOGee Coppo had a great write up tonight, thanks Axel for posting. Well done to Adam White as well. Great thoughts. I enjoyed their stab at what we might be worth one day, and that's a conservative outlook. Sure it will take some time to build to those levels, but remember, when people are in pain, they are going to do a lot to address it. This is quite different from a nice to have Apple 14 or a shinny new car. A safe pain solution literally is a Must Have.
THANKSMany thanks to the many contributors on here, not always positive, I get that...but it helps to keep us safe. You know we are all a team, yes working for ourselves and our own holdings, but we certainly feed of each other well. Mud slinging is bound to happen but it is so minimalistic and allows us to focus on the hard core research in terms of science, accounting, and general investing theologies.
Super thanks to the PAR staff, I know for a fact that many of them aren't just doing the std. 38 hours per week...late nights and early mornings, you know who you are. We company owners do thank you for getting us to this point. Its the future points we very much also look forward to. Hang in there...
Now your job gets more intense, just imagine the new leads, juggling all the studies and questions being asked by new fundies. With Marco's and Paul's lead, we will be opening up to new parties and investors.
Mate, I'm so proud to be a PAR holder...its been a while, but these things take a while...how good does it feel to say to ones self, we are getting closer, its getting real.
Enjoy your night...
I am!
Mozz
References1)
https://advancedmathyoungstudents.com/blog/?p=7972)
https://www.fiftyonecapital.com/paradigm-biopharmaceuticals-an-interview-with-paul-rennie/3)
https://hotcopper.com.au/threads/back-to-the-future.6811324/#post-622193134)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2711509/5)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5939920/
(20min delay)