n a matter of weeks, (hopefully not months!) we should hear back from the TGA.
Tonight let's explore a little more about what this means, what are our chances and if we do make it, what's next?
THE TGA
Let's start with the vision the TGA has1:
Hmmm good one, wellbeing for all Australians sounds like they want a broad range of benefits...now that's something right up iPPS's alley. Reducing inflammation is as broad as you can get! But we are focused on bringing Pain down and improving function utilising an OA lens.
No problems, I don't really care too much HOW we get there....I just want to GET there!
THE PROVISIONAL PROGRAM
Designed for allow drugs onto the market sooner, the Provisional Program from the TGA was introduced in 2018.
It's aim is to try and bridge the lengthy gaps between promising drugs going through trials and being allowed onto the market early. "Time limited approval through the provisional pathway is based on the evaluation of preliminary clinical data where there is the potential for a substantial benefit to Australian patients".
In order to become eligible, drugs have to satisfy the following 5 conditions:
THE START BEFORE THE START
Before we even tackle some of the stats and what it means for us personally, we have to pass a big hurdle, it's called the DETERMINATION.In other words, before are we even allowed to put in an application for this super program, we have to get the judge, the TGA, to determine if we are even eligible.
All very good Mozz, but what has happened in the past? I mean the recent past? Do we stand a chance? Well of course each drug will be assessed on it's own merits and we know the 5 criteria they will look at. But let's take a look at last year's Provisional determinations as a kinda rough dipstick:
Table 7: Number of provisional determinations granted :
Now that's what I'm talking about.
29 applied, 29 approved two years ago. Last year it was 15 out of 17.
Now that in isolation tells us something, but how about this next little gem:
MORE HOPE FOR US?
Now the above stats are interesting, but take a look at the following paper that covered provisional applications from 2018 to Oct 2021.This was their conclusion:
What??!!
So most of the drugs evaluated didn't offer any substantial additional therapeutic value over existing medicines!
Mate, wait till they see iPPS!!
Crickey Jack...
Pain dropping like a lead brick. Function Improvement Impeccable safety ...but additional benefits like how long the wonderful effects last... What about how it's not intraarticular, so in other words it is patient convenient Is non toxic and non addictive....it also doesn't have to be applied to the actual source pain area! It acts simultaneously across all joints!! ...What about duration, you don't have to take this drug every day or every week forever.
Hellllooo multi modal.
This isn't a pain BLOCKER, its not an immunosuppressant... This isn't a cytokine stopper, it's a down regulator. This acts in multiple systemic ways. This is the substantial additional therapeutic value, like you wouldn't believe.
It's actually going to blow their minds (spec statement, subject to decision, well, determination). .
TGA, YOU are about to be the first agency on this living planet that will allow us to file an application for one of the best (in Mozz's mind of course) drugs on earth.
Just earlier tonight I was chatting to a great pal and telling him, mate, wouldn't it be great if one day in the future we get covered by a real good magazine, one that I don't get enough time to read....
Time Magazine!
Here is what imagine I had in my mind as I was chatting to him:
When could we see our name on the front of Time?
THE FUTURE
When (ok ok IF) we get this determination in our favour, does this mean, dear Mozz, that our share price will Leap? (See Pool_Head_of_State, I didn't say LAUNCH)...Well maybe, maybe not. Why? Isn't this the greatest thing, like, ever?
Well yeah it is,....but the market kinda sorta knows we have a good drug...they want more of....
Show me the money! (Note: It's not lost on me that this was a movie about managing NFL players...PAR already have a link between the NFL Alumni). The NFLAA has some 10,000 members in it. There is a good chance we will recruit a number from this association into our P3.
The market wants funding certainty. They want us to be funded so we don't have to do the biggest, heavies, dilutive offer under the sun...so much so that your slice of the pie was 0.001% of the company, will now be 0.00000001% of the company.
No one, wants that!
Until that step is passed, well we will be in rough seas and armed only with a little wooden paddle...(I wonder if this Par-paddle is made of European Beech bark? Hello, does anyone have bene's phone number? Can we convert it to iPPS in our spare time as we sail the hopeful oceans of success?).
One day we hopefully will convert this row boat to a ship!
BUT, if we get this determination in our favour, what it will do is that it will help with any parties behind the scenes that may eventually chat to us...it will show them that there are agencies that are starting to swirl...starting to realise, that hang on, this PAR company from Down Under may actually have something worth pursuing?! It will be further validation for us.
It will also be certain revenue coming down the pipe in an established western world market, that will be worth paying for.
If we get the Go the next step will be to duly file the full application, it will take a few months to compile and then the giant wheels of the TGA will turn...that process could take around 150 to 200 working days...a fairly long slog, but if it's successful, first time revenue across the country awaits. That will be exciting and will be a great test ground for PAR. A separate distribution deal for Australia with it's approximate 3.5 million5 OA sufferers may then occur.
Yes we may be up against the great halls of Oncology...the best drug titans in Haematology and lately, the super drugs in the Virology space that have all had a successful Provisional in Australia....but we may actually be on the verge of creating an entirely new hall of fame wing just on our very own.....
n a matter of weeks, (hopefully not months!) we should hear back from the TGA.
(20min delay)