Ceviche,Appreciate your comments and you have been a long time...

Ceviche,

Appreciate your comments and you have been a long time supporter of PAR despite all the ups and downs.

I must add here though that while it is darned frustrating that we sit here in 2024 and we are still months away from starting the last part of our clinical trial program, I do want to state that it is a good thing, a really good thing that PAR didn't wind up the 002 Stage 1 really quickly and rush through a request for Stage 2 with an "Immediate start request" to the FDA.



Why Not?

Because of 008 12 month data.

This data provided some incredible first time seen benefits including, but not limited to the following:

• "No OA drug has previously shown durable and meaningful improvements in pain

and function at 12 months after a single course of treatment"



That's patient convenience at the highest level. The FDA need to see this.

• In the PARA_OA_008 clinical trial, participants receiving 2 mg/kg iPPS twice

weekly for 6 weeks, reported clinically meaningful outcomes at 12 months (Day
365) compared to placebo as follows:
o Significant pain reduction (p=0.054).
o Significant functional improvement (p=0.048).
o Durable improvements in stiffness.
o Significant improvement in overall WOMAC scores (p=0.054)



Remember, don't get too hung up on the p values when n is so so low. (15 !) No I didnt drop off a zero on the end, it was actually just 15 patients, this illustrates the astonishing drug effect size in play.

Now understand, as n = 15...p values approaching 0.05 are going to be good....but PGIC? The actual patient's account of what they are experiencing?

• Patient Global Impression of Change (PGIC) results demonstrated highly

statistically significant improvements for iPPS, at a dose of 2 mg/kg twice weekly
versus placebo (p=0.005) at 12 months.



That statement above WASN'T AT DAY 56...


Nope not even at day 128...
...it was a FULL YEAR later.



All of the above lovely...now add this statement after 12 months of observation and after NO intermediate dosings:

• Cumulative rescue pain medication use was over five times higher in the placebo

group at Day 365.



To say nothing of the amazing MRI's that all came out...it took time to do the final analysis...there are so many data points, they wouldn't have been ready to submit all of that stuff till earlier this year. I suspect there will be tangible and material benefit of taking their time and compiling it all properly for the discussions with the FDA. This is an enormous amount of additional work but also its supremely exciting never before seen data. To get these sorts of observations in just 128 days and within a year is simply unheard of.



My point of all the stuff above is that this data needed to be presented to the FDA so that they would understand that we aren't just merely Pain and Function, there is a whole lot more to the story. The iron is hot...strike it properly.

PAR, it hurts to wait and see our SP channel like it is at the bottom of the barrel for weeks on end...but please please ignore us at HC, take your time, get the best protocol you can, in, broaden the prospects of our eventual label, then and only then strike a good deal (don't wait too long for this though!)...well, Regional Deal..and then set us up for something so much brighter in the near future.

An OA Global deal that's aptly commensurate of our drug's incredible value.





DYOR very much required



Ref: https://app.sharelinktechnologies.com/announcement/asx/76393c2170325bd8cd425f9c4d0ffaae