Mozzarc
Emerged
Thought it was about time for a MINI update on where we are at.
Easy to think things are going too slow.
Easy to wonder if PAR are actually doing anything productive and actually progressing when things are so quiet?
They are busy bees...
Right, so two main prongs at the moment...let's cover each at a high level.
PRONG 1
FDA
So within this, there are two pieces of info, the results from our earlier meeting this year and the submission of a number of data items, some included below, but most likely not limited to:
A) Pre Clinical Data
B) Dosing data
C) 002 Stage 1 Data
D) 008 Data
There would be a lot more data in this pack including safety data as well.
This is no doubt going to take some time for the FDA to work through. I would love to think its within a month or two from now? But that's only a guess and if they come back to ask questions... well we have to be ready for this process to take even more time.
Is it worth it? Of course...there is no safe OA drug out there in the USA or harmonised with Europe. We are submitting something pretty darned special, we aren't going to apply and treat eventually to a handful of patients, I'm talking scaling like you just wouldn't understand.
There is NO competition.
PRONG 2
TGA Determination for Provisional Application.
This one is actually also quite interesting/exciting. It's also a little risky.
Risky cos it is one and done. Muck it up and we don't get a second chance.
Exciting because this opens up a separate gateway that while it still has a definite link with Prong 1, it's also independent.
Let me explain.
So if it's determined we are eligible to apply, we need to also show that a chance of a Full licence is possible within 6 years.
What does it give us? The ability to start selling in Aus BEFORE Phase 3 in the USA/Europe completes! Now before we start jumping up and down, I do need to state that this will take some time...we'll get a to a rough timetable in a sec.
Where are we in the process? See red circle below:
The next step once we put it in, is for the TGA to determine if we have a case to put in a full application. It will either be deemed as "Eligible" or "Not Eligible". That, either way, I would think, is definitely announceable to the market. We will know one way or the other within 20 business days of applying for the determination.
Here is a rough Pathway, but remember, this is literally my stab in the dark....see further points below.
1. APPLY FOR DETERMINATION
This could literally by days away, it might be a few weeks away.
2. RESULT
According to the legislation, the determination will be made within 20 business days...I've got this as July, it hopefully won't slip into Aug.
3. IF RESULT SUCCESSFUL, COMPILE APPLICATION
Yeah this is going to take some time, sure PAR can do some work in the background but the bulk of the work for the main application will come later, on the proviso we actually get a positive determination (acceptance from point 2 above).
4. FILE
Well, once the work of Point 3 is done, it's a case of just submitting it. Then it's more waiting....see next point
5. TGA TO PROCESS
Yeah this is the boring part...we wait...and wait...and more wait.
Mozz waiting...
6. PROVISION GRANTED
Yeah this is party time...and perhaps even coupled with a few drinks.
(Drink in moderation)
A successful TGA Provisional will mean at least three things for you and I
A) Party Time. Yes yes we covered that.
B) Real first time revenue, across the country! It will prove the model, it will allow PAR to forecast, it will test our distribution and logistics...
C) Validation - Others will look at us and the potential investiture and interest will increase.
NOTES:
I've built a little fat into that timetable above, but I could've gone even a bit more crazy...HOWEVER, there is also at least some small chance that things go quicker....one of the pathways that's available to sponsors under the TGA is a Priority type application but let's not count our chickens yet, hey?
Speaking of not counting chickens, if in the event we get a Rejection from the TGA determination, there is a process of appeal within 90 days. To be totally honest, I rate us having a really good chance at the TGA Provisional Determination. Don't forget, I, like a few on here, have been really waiting since 2019. That's a long wait, that's not only cobwebs buts it's a extra few grey hairs since back then!
Ah to be my kids, I think they are the ones that will really be the benefactors of all this research and takin' a punt!
I like this stock not just because of our massive future potential...I like this stock because they are taking their time and going about it methodically, though it's frustrating at times. Finally, they know the value of what we have, they know it's not just OA that's the only indication at scale.
They know what the future might be like.
My opinions of course.
Easy to think things are going too slow.
Easy to wonder if PAR are actually doing anything productive and actually progressing when things are so quiet?
They are busy bees...
Right, so two main prongs at the moment...let's cover each at a high level.
PRONG 1
FDA
So within this, there are two pieces of info, the results from our earlier meeting this year and the submission of a number of data items, some included below, but most likely not limited to:
A) Pre Clinical Data
B) Dosing data
C) 002 Stage 1 Data
D) 008 Data
There would be a lot more data in this pack including safety data as well.
This is no doubt going to take some time for the FDA to work through. I would love to think its within a month or two from now? But that's only a guess and if they come back to ask questions... well we have to be ready for this process to take even more time.
Is it worth it? Of course...there is no safe OA drug out there in the USA or harmonised with Europe. We are submitting something pretty darned special, we aren't going to apply and treat eventually to a handful of patients, I'm talking scaling like you just wouldn't understand.
There is NO competition.
PRONG 2
TGA Determination for Provisional Application.
This one is actually also quite interesting/exciting. It's also a little risky.
Risky cos it is one and done. Muck it up and we don't get a second chance.
Exciting because this opens up a separate gateway that while it still has a definite link with Prong 1, it's also independent.
Let me explain.
So if it's determined we are eligible to apply, we need to also show that a chance of a Full licence is possible within 6 years.
What does it give us? The ability to start selling in Aus BEFORE Phase 3 in the USA/Europe completes! Now before we start jumping up and down, I do need to state that this will take some time...we'll get a to a rough timetable in a sec.
Where are we in the process? See red circle below:
The next step once we put it in, is for the TGA to determine if we have a case to put in a full application. It will either be deemed as "Eligible" or "Not Eligible". That, either way, I would think, is definitely announceable to the market. We will know one way or the other within 20 business days of applying for the determination.
Here is a rough Pathway, but remember, this is literally my stab in the dark....see further points below.
1. APPLY FOR DETERMINATION
This could literally by days away, it might be a few weeks away.
2. RESULT
According to the legislation, the determination will be made within 20 business days...I've got this as July, it hopefully won't slip into Aug.
3. IF RESULT SUCCESSFUL, COMPILE APPLICATION
Yeah this is going to take some time, sure PAR can do some work in the background but the bulk of the work for the main application will come later, on the proviso we actually get a positive determination (acceptance from point 2 above).
4. FILE
Well, once the work of Point 3 is done, it's a case of just submitting it. Then it's more waiting....see next point
5. TGA TO PROCESS
Yeah this is the boring part...we wait...and wait...and more wait.
Mozz waiting...
6. PROVISION GRANTED
Yeah this is party time...and perhaps even coupled with a few drinks.
(Drink in moderation)
A successful TGA Provisional will mean at least three things for you and I
A) Party Time. Yes yes we covered that.
B) Real first time revenue, across the country! It will prove the model, it will allow PAR to forecast, it will test our distribution and logistics...
C) Validation - Others will look at us and the potential investiture and interest will increase.
NOTES:
I've built a little fat into that timetable above, but I could've gone even a bit more crazy...HOWEVER, there is also at least some small chance that things go quicker....one of the pathways that's available to sponsors under the TGA is a Priority type application but let's not count our chickens yet, hey?
Speaking of not counting chickens, if in the event we get a Rejection from the TGA determination, there is a process of appeal within 90 days. To be totally honest, I rate us having a really good chance at the TGA Provisional Determination. Don't forget, I, like a few on here, have been really waiting since 2019. That's a long wait, that's not only cobwebs buts it's a extra few grey hairs since back then!
Ah to be my kids, I think they are the ones that will really be the benefactors of all this research and takin' a punt!
I like this stock not just because of our massive future potential...I like this stock because they are taking their time and going about it methodically, though it's frustrating at times. Finally, they know the value of what we have, they know it's not just OA that's the only indication at scale.
They know what the future might be like.
My opinions of course.
