here is a real chance that one day we will touch the four corners of the globe - in other words we may have a real presence in places far and wide. Why then am I singling out Queensland tonight?
In fact let's go narrower....ROSS RIVER!
Ah now there is clue. Sit back...sip back and do enjoy this post!
PROLOGUE
Before we get into Ross River and what it might mean for us, it's been a fabulous week, a "hat-trick" indeed, good one PharmD, you were right!
1) EMA and FDA harmonisation announcement. 2) Bene supply and relationship strengthening. 3) Additional SAS data in WOMAC format and the results were better than last time!
Analyse each one independently and you can see they have all good connotations for us going forward, it all adds weight to what we have and own.
Ross River of course is a place and the term for the condition was coined as it gets quite tropical and humid there and what breeds best in those summery heated but damp conditions? Mozzies! Just my nick name is the only commonality, don't worry, I won't bite....unless you are a foreign company and want to take over us prematurely, then I will bite and kick.
Ross River...just outside Townsville.
Ah a tranquil beauty to be enjoyed right in our backyards ? Yes, but it shares a name and a terrible affliction and something that's firmly on our radar....
THE AFFLICTION
Yes Ross River fever is an inflection that is spread by mosquitoes. What are the symptoms? Well of course one of the main ones is what we are tackling; Joint pain. It also can result in:
Fever Rash Headaches Body Aches Joint Swelling, Pain and stiffness...
The problem is that some will have these symptoms for days...but in others it can last for weeks and months...and the pain can be crippling...What are the current remedies?
Well for joint pain....Panadol and of course NSAIDs...
Are you new to PAR and new to Mozzarc Research? There is a bit to catch up on but in brief, NSAID is one of the so called standards of care...the problem with NSAIDS are many. NSAIDS can result in many side effects not limited to stomach pain, heartburn, nausea, diarrhoea, ulcers and bleeding. But it is now recognised that these are in fact so bad that they need to come with warnings......warnings?
"Except for aspirin, all over-the-counter NSAIDs now must carry a warning about the risks of heart attack and stroke along with other side effects". 2
But this is not all....
"They can cause high blood pressure and kidney damage in some people. They can also cause potentially severe allergic reactions". 2
This is what we are up against....Paradigmers, it's rather clear to me why the FDA and the EMA have not insisted on an active arm in our upcoming Phase 3.....The current std of care...what an active arm might be, is dead in the water, it has no comparison to us.
FAST FACTS
Until July 2014 CHIKV never was present in the USA. 3
Ross River Fever was first detected in Australia in 1959. 4
Within just one year of appearing in the USA there were some 1.1 million cases of CHIKV in a year. 5
JUST HOW GOOD ARE WE?SHOW ME THE MONEY.
Mozz I want evidence...no no Mozz I don't need some far away study conducted involving donkeys or rats or a petri dish...I want actual human evidence...not only that but I want someone from here, within OUR ranks to give us some evidence!
Where? Here in Australia?
Well yes but I want someone close to us.... I mean someone that was on HC! Someone that was really involved, like close to the researchers, to the lead Docs. Someone that also has a partner that actually had Ross River and as a double bonus, they themselves had a cartilage tear later on and this guy is in the medical fraternity?
Gee, you don't want a lot do you? Read this (See below). I was amazed at the time, I still am, and I reckon I have read it at least 10 times over the last 1.5 years or so.
THANKS MOZZ, SO WHAT'S THE BONUS THEN (I want more)?
Well Paradigmers, we know the usual pathway....Speaking of pathway, let me tell you a small story before we continue....I'm currently in the middle of watching The Hobbit for the second time...Gee Peter Jackson did a wonderful job. I loved the book when I was in Grade 6...I think his movie rendition is sterling. Great cast, great story....Relevance to us? Plenty.
WE ourselves are on a somewhat unexpected journey though it is getting more defined as we traverse through the hurdles and achieve milestones ...for me it started with our Hay Fever indication...it has moved to the exciting field of OA and the new realm of MPS...I knew not a thing about MPS before investing in PAR as an example. The learning curve has been steep but terribly enjoyable.
A good movie, a great book...parallels with us? Yes I hope our story plays out favourably too!
Forgive me again but I must digress yet again, how pretty is Evangeline Lilly....perfect casting for the role...
Ok so Mozz, where are you going with this, are you yourself getting off the path? Yes WE are on an exciting and somewhat magical pathway....and like the heroes that went through the big black scary forest in the Hobbit and were instructed to stay on the path...we too find ourselves on a very potentially rewarding path on our OWN quest... Paradigmers...how about this for a different pathway, as a possible bonus to consider:
DEAL BEFORE A P3????
I always assumed that as far as the Viral Arthritis "twins" were concerned (RRV AND CHIKV), it would be:
Phase 1 Phase 2 Phase 3 DEAL and Sales
But how about this possible pathway for your perusal?
Mozz, evidence please, you can't just go around these forums and randomly speculate and wish away like some wizard out of some fantasy type movie....ok below is reference to an article whereby it clearly states that there is a pathway possible that the DOD get usage of a drug BEFORE a P3.
How is this even possible?
Because you forget that the Military AND the FDA are both US Government institutions...they work hand in hand...and there is at least some possibility of getting an actual deal done before we even have to do a P3.... sure it may not work out exactly like this but there is at least some possibility that the DODloves our drug, it's gets the troops back to serving within weeks instead of months...the efficacy is so good and what is included in the terms and conditions of the deal? Well maybe they help us with the 3rd phase..maybe it is just a good word in the FDA's ear....maybe it is some payment to help out with the trial cost? Perhaps it's an upfront payment and/or ongoing revenue for us?
Don't discount this theory altogether fellow investors. A lot may hinge on how our drug gets classified in light of the Viral Arthritic conditions we are investigating, is it a “treatment” or “research.” 6
Heard of Force Health Protection?
Here are some details; "...the Pentagon also has a unique team called Force Health Protection in its corner. This group is devoted to managing and procuring investigational drugs and other medical products on behalf of the US Army Medical Materiel Development Activity (USAMMDA), a division of the USAMRDC." ... and further, a senior scientist from the above team said in an interview back in 2018, “We make products available to the Warfighter, and in some cases dependents, prior to their licensure,” he said. “But all of this is done under appropriate US Food and Drug Administration regulatory mechanisms.”
Even just earlier tonight we hear that the US president is also being treated by the yet to be approved (by FDA) drug, Remdesivir.
Paradigmers, I'm hoping we get the peer reviewed manuscript back within a few months and then the talking/dealing may start? I'm not saying it WILL go down like this, I'm just alluding to the possibility that it COULD take place like this or some other pathway we may not have considered.
Finally, you know what? With so much going on and on so many fronts, next year could really be quite a year for us.
DISCLAIMERS
Forward looking statements and references to witchcraft may be present in this post. I'm no wizard. Please do your own research. Understand that we are still a speculative company, we are still young, there is risk, not all may play out as I want....No matter, from where I stand, the pathway looks bright and well illuminated. Be patient...follow the pathway and let's see what transpires!
here is a real chance that one day we will touch the four corners of the globe - in other words we may have a real presence in places far and wide. Why then am I singling out Queensland tonight?
Until July 2014 CHIKV never was present in the USA. 3
Ross River Fever was first detected in Australia in 1959. 4
Within just one year of appearing in the USA there were some 1.1 million cases of CHIKV in a year. 5
(20min delay)
