Pool_Chairman, A very good evening to you.Happy to assist, you...

Pool_Chairman, A very good evening to you.

Happy to assist, you are doing great on your own by the way!


You are correct. The FDA knew what kind of scale we would potentially role out this drug to...(my thoughts). They wanted to not just rely on the pharmacokinetic studies we were asked to do along with the various toxicology reports. They wanted finally, the MED. They wanted us to utilise the most minimal drug possible to derive an efficacious result.

That was always going to be mandated, a SubQ drug is finally systemic, it can affect and accumulate in many organs. On top of that we are multi-modal, there is a lot to investigate. The hurdles but also the stakes, were always going to be higher for us.


We had to go through the 002 Part 1 dosing study to be even considered to continue onto anything further.

Yes the chosen MED then became the 2x2. It took some effort, it took some time, this is the way of the FDA. It's not a joke to be able to sell one day into the biggest markets in the world, that was plural, SIMULTANEOUSLY. There is a real lot riding on this last P3 for us.


So one of the earliest studies PAR conducted in the BMEL area was a Phase 2a.

Yes, as you suggest, the results were off the charts.


You thought we only had a small sample with our 008 (reminder, the 2x2 arm had a total of 15 patients that were reported on!!)...not 150, fifteen.


Well it was LESS in this Phase 2a....What, less than 150?

No, less than 15.






9 patients.

I'm going to include the full paper in the next post cos it is quite a read...but one paragraph for you, I should print it out and frame it...


"The changes in BML and effusion-synovitis from baseline to End of Study were examined in 9 subjects
who had completed the course of PPS treatment. Overall 6/9 (66.6%) participants showed reduction
in BML; 8/9 (88.8%) had reduction in effusion-synovitis volume. There was a significant reduction in
BML volume in lateral tibia , and a marginally significant reduction for total tibia .
Similarly, there was a significant reduction in BML maximal area in lateral tibia and total tibia
. There was a significant reduction in effusion-synovitis volume in suprapatellar pouch
and total knee . There was also a significant reduction in effusion-synovitis maximal
area in suprapatellar pouch and total knee ".


Look at the p values
on n = 9

Helloooo fellow holders, our P3 will have n=233

How many 9's in 233?

Anyone?

All I want is to be able to see the PGIC (and Pain!) p values AFTER 233 people have gone thru our study.



The above paragraph ain't just commenting on one particular compartment within the knee cavity.

I am reading the word significant all over.

Pool_Emperor, I thank you for bringing this up. It is a fresh reminder of what I own.


I am an owner of this.


I had a lovely dinner with a pal of mine tonight, yes there were a few stories to be told...including my inflammation firestation story and my watering the new plant story.

But it is the older stuff that is gold, cos we all forget about some of the stuff we have read and some of the science and results that have occurred.




So yes, getting back on track, our results in such early studies will not only be replicated but will be bettered.

How do I know this?

Well amongst many reasons, one of the biggest reasons is that PAR knows how to better handle the Placebo effect.
They have learnt a lot. We literally saw this improvement from batch to batch in our SAS program.

There are a number of other measures PAR have implemented. One of the biggest ones we will hear in an upcoming webinar...about the ADP measurement.

If they don't mention it I will raise it as a question.

That one measure will assist in the results. It has to do with Patient recall -v- Womac recall.

Par-folk, these are measures I know...there will be many I don't.

What I do know is that the FDA have passed us...they have allowed us to open our P3. This in itself is validation of the science, of the pharmacodynamics. But not only we are harmonised with other prestigious authorities...we have a Fast Track and you know what? I'm hoping we will score at least one or two more designations in our upcoming journey. Get anything else and this story is going to change gears.



So Yes Pool_OverLord...you are correct, we should not only expect a similar efficacy profile, we should literally expect a better one.



The stats don't lie.


The stats don't lie as long as the protocol is adhered to and the patients are granularly guided and monitored. This takes time, it is time that PAR MUST invest in to achieve the ultimate goal, the passing of that P3.












DYOR as per usual