Dear Parad
igmers,
*rubbing hands together*.
Not unlike Coppo...let me get into this....
Ahh this is going to be fun...grab that iced latte....perhaps one of them special
Pool_King's cocktails, yeah the green Fairy Dust infused one...or perhaps just a mild tea....I had a great day today...I got lots to say...this could get long...you sip, I'll type...let's summarise.
THE SCENEOk sure, wasn't quite the AGM I'm used to back in the pre covid days...but no matter, we were a small group but a broad group and you know what, that's not unlike our share holder base, perhaps peppered with a few youngsters, a few freshers...and then you have the old seasoned (that's a nicer way of saying what I was going to say about people like me) crew. We have those that have a small sliver of shares and are perhaps building up as new info comes to hand...and we have the big wigs, you know who you are!
These smaller type AGMs won't be small always...oh yeah, I can see us in a different setting in just a few years from now...cast of hundreds...having to get bigger venues, I dunno about the Berkshire Hath. meetings, 40,000 is a big deal and Im not suggesting that but I see us scaling quite nicely in the not too distant future.
THE MEETINGWell
Eire2011 was quite correct, a few nuggets, a few easter eggs scattered in there, but you know what? I counted more than 3 or 4, true my easter egg counts include those little cadbury ones...you know, the small ones...it all adds up.
Example? Well in the first 8 mins or so Paul mentioned a new one for me...
Get Smart, what had this to do with the meeting?
Ok the link is
Siegfried..I know there are at least a few of you that have watched this 70's tv series. My point here is that that was the same name that Paul mentioned... early on in his presentation.
Mozz, please clarify.... Ok what am I inferring? I mean Paradigmers, there is a lot going on that we don't know about, in the background.
Here is the company, just one out of a number, who we work with in varying capacities...
Paul called this company out as an example and I've never come across it...there are so many on that list that I haven't heard about or know about our interactions.
I'll come back to this point soon...
I must say I thoroughly loved this new introduction of a R&D day. It's a great way of :
1) Keeping tabs on the multiple trials and programs that are going on
2) Hearing from our CMO, I did enjoy hearing her answer some questions today.
3) What a good way to keep us shareholders informed and yes, involved, bravo PAR. I don't know about you, (I actually do a little) but I want
to hear feedback, I want to be informed and hear what is next - oh and don't you know it; I want to ask questions and learn more!
It sounds like it might be an annualised event. All for it.
Right, remember I'd come back to the point above about our friend from Get Smart? Paradigmers, it's easy for us shareholders to get bored in between...admittedly it's a bit like a test cricket match sometimes...specially on some of those maiden overs...where not much happens, there are no sneaky runs made, there is no grand slam 6's that are hit. Yes of course we sometimes get frustrated, we wonder whats happening and why we go for weeks without hearing anything, has Paradigm fallen asleep? Are we still on to a winner? Is there some hurdle?
Here is an example of what happens in the back ground that YOU AND I DON'T HEAR ABOUT:
Example 1 Paul clearly mentioned today in the AGM, PAR have been working on the clinical toxicology studies. This is taking place in the background, these are the little 1 runs we are racking up on our scoreboard, it's stuff that has to be done and contributes to the over all requirements and progression. GLP standards...GMP also. GLP stands for Good Laboratory Practice and is an important part of the dossier we finally submit, so too is Good Manufacturing Process. New guys? Here is a link to a much more in depth look-in at what exactly a GMP is and what role it plays for us. LINK ----->
GMPExample 2PK (Pharmacokinetic) Study. Paul also mentioned this one, a Japanese study that needed to be done. We had the Western patient study but the FDA wanted a comparative Non Western study. This has also now been completed. He also mentioned Cmax in Adelaide. Why did PAR do this? As they wanted to ensure there are no surprises at time of IND or after. Here is another link for those that are curious --->
CMAX. I think this one of the CROs'.
My point of the above examples is to illustrate that this game of cricket is still going on, perhaps we may not get updates every week...but things are happening, it will take it's own time. "Be patient" is a theme I mentioned that kinda featured a bit between the beers at lunch today.
MORE LEARNINGSRightio, so then Paul mentioned about GLP standards and toxicology studies. He also mentioned about the confirmatory trial which we know about but what I learnt was that this trial will most likely have an Australian component, and that's a good thing. It de-risks us and it can help with the time management of the trial. As we know, Aus is a very safe place to be right now...
At around the 28 min mark Paul mentioned about the EMA and the wonderful news we got not long ago, that we can start...yep, EMA has cleared us to start a P3 any time now. He also said those magical words which I suspect would have had the same magical effect as one of them Green Fairy Numbers...."FIRST IN CLASS". This is what we have Paradigmers.
Another interesting quote (nugget) I got from Paul was in reference to the TGA and what the TGA are essentially waiting for in terms of us starting the second stage of the TGA application process:
"They have asked questions which will be answered by the FDA"In other words, we are waiting for the Type C to come back from the FDA...then we can proceed...
FIRST TIME REVENUESYeah this one was a good one, that little snippet that
Torpy caught...I was sneaking a quick peak at my HC session on my phone and saw Torpy's post on HC, Paul was behind and hadn't gotten to that slide yet, it was a heads up for me when he got to the slide...that was some news that hit the Mozz radar for sure.
Thanks for the head's up!Now this is a delicate one, and again as Paul mentioned it will test demand...it's a tricky one because they could potentially influence, at least to some extent, future pricing. If they make it too cheap, then they could be shooting themselves a little in the foot...if it's too expensive the demand could get affected? Not sure on that one, we are still going to experience demand at a lot of high price points perhaps (my views)? Think about the sheer volumes, Coppo also mentioned it.
At the 36 minute mark Paul mentioned the efficacy of our current rivals (yeah right, "rivals")...
30% reduction in pain from NSAIDS
and about an average of 30% for opioids.
Nice to hear this again....in truth, I can hear this a few more times..music to my ears compared to our results. And we are safe, much safer than the so called std. of care.
BRAZIL!
Paul mentioned Brazil as a recruitment site for MPS.
Take a look at this post for the mentioning of Brazil and how it features for recruitment despite Covid cases prevalent there.
LINK ---- >
BRAZILTHE TWINSPaul also then went on to mention the Viral Arthritic indications...he also compared what they gleaned in terms of observation of the data returned from these studies to OA, another nugget?
"Striking Clinical outcomes"...and the fact that were some very similar observations in terms of great action by the wonderdrug, iPPS.
NUGGET TIME?The 45 minute mark saw me very furious in my note scribbling, I got some more nuggets!
How about this.....3 more patents filed! Jeepers, as if we don't have enough already going on...
2 x Pain
1 x Respiratory (no doubt that's the ARDS...newer folk, another link for you just below, you gotta do a bit of this link surfing if you wanna ride the big waves with us seasoned investors. Myself and others can hand a lot to you on a plate, the amount you eat is finally up to you!)
LINK ---->
ARDSThe next Easter Egg was another quote....
"Once data comes back...there is a solid chance of partnership"Basically Paul meant, we get the product to a certain point and then we partner. This gives us shareholders insight. The CEO and the board know very well what we have, what is the potential, what could be the future. We aren't giving in too early. This will be MULTIPLES of what we are worth on this very day if we hold on...we start P3, we get some data back and then the world gets a sense of exactly what we have.
December isn't far away, it is in December that we should hear back from the FDA in terms of what we exactly need to do for the upcoming P3.
At the 51 minute mark Paul again mentioned some more background work that is taking place, packaging is being thought about for post Phase 3 and the potential format (pen device was mentioned?). He also mentioned about the manuscript for what I call the Twins...RRV and CHIKV.
FORMAL PART OF AGMPretty stock standard here.
Sad to see a director go, but new blood was flagged to be appointed including PAR looking for Deal making experience and preferably someone from the USA. This is welcome news for us, a broadened board specially as
TeddyWestSide puts it, recruiting a board member from the country that represents some 50% of the global pharma market. Compelling.
I must say I personally was a little disappointed to see some of the Negative votes, but I understand this might have been some back lash for retail not being involved and its very evident that Paul and the board are acutely aware of the retail holders. Paul did mention in the first raise, retail only accounted for some $200 K of funds raised, but perhaps that wasn't the point, its not the dollar amt, its the including of retail holders. Anyway, we won't be missing out in the next round if there is indeed a future raise required.
I also didn't quite understand why anyone would vote against the CMO package. How else can you attract such raw talent? What, you mean you want to under pay and skimp on that role? Who do you think you will get ? Someone that has had no FDA submission experience? Why would you risk such a dumb move? Yes we shouldn't waste money...yes we shouldn't over pay...yes we are a small and young company. But YES, you get what you pay for.
Yes yes I'm off my soap box now...QUESTION TIMEMate, I was impressed we got our questions answered...I nearly fell off me chair when he said "Mozz". Trying not to let my ego explode but I am happy we are being heard and I am acutely aware it is
not about me...it is about YOU. If I didn't have YOU to listen and your feedback...I wouldn't be doing this. We are a collective, we are a group, we listen to each other's opinion in a professional manner and debate as we are here to simply learn, further our great company and you know what, make a dollar or two along the way.
THANKSOk I'm going to call it a day here, has been a long one but a enjoyable one. I must again thank Axle for organising and running around. I thank the Paradigmers that showed up. I know they enjoyed each other's company.
I also must say a big thanks to Simon White, our Director of Investor Relations, he has worked very very hard to get the AGM happening and ensuring it is as seamless as possible. He has been involved in some really high quality work and projects and it is evident the great impact that he has had on the company.
I also publicly acknowledge the staff of PAR, I know how hard they are working and yes, the best is yet to come but also a sh&tload of work is yet to come too!
There will be a Part 2 to this when I get around to it, still got a few more points I've scribbled down....
DISCLAIMERSThis is my interpretation and while every effort is taken to ensure accuracy of the day's proceedings, it's best to DYOR.
(20min delay)