GrandRhino
Founding Member
Mate, I'm still celebrating Fast Track, a bit out of the blue, darned exciting.
But not unlike the company, we don't just wait and celebrate one train to push off, we have a few. This makes us a unique company and its only going to get more exciting as more programs come on line in the future (My views). Yes a real boost for us today and its comprised of two distinct components as we know:
1) DIRECT BENEFIT
Quicker pathway
More focused liaison with FDA
Rolling reviews
2) INDIRECT BENEFIT
Recognition by the FDA
Market recognition
Will assist in new eyes to us, think not only shareholders/instos/analysts...I'm also talking CEO candidates and potential Deal partners.
BUT..I'm already thinking of another catalyst somewhat in this space, in this line of thinking. What I want to set on my horizon is TGA Provisional. This should now be playing in the minds of the Par echelons....
We have clues already as to what the TGA want....they want something novel....They want something the market hasn't seen before, that the market doesn't have.
Paul mentioned PAIN reduction...and FUNCTION improvement (in the interview with Scott) ...there are various drugs that can lower pain... and others that can increase function... but are they safe? Does it last? Is it effective...well we know the answer to those questions...But what does the TGA want? They want something on top of that.
SO whaddya reckon, are we novel? What does the FDA say, Fast Track, that's a great additional start to us through the acknowledgment today of addressing the unmet need, addressing a serious condition......but the real test will be 008.
Donna and Paul separately gave us the clue. Paul mentioned that the TGA want something novel...and Donna also said the same thing more recently...novel, and a clear advantage over what's out there.
"It will really depend on how the data set looks and what the strength is around synovial fluid analysis as well as duration of effect". "We certainly will want to approach the TGA once we feel we have a strong data package".
- Dr Donna Skerret 2021 AGM
The novelty will be any whiff of DMOAD.
TIME?
Again on paper, not a quick process, first we have to wait for sufficiently good data to come out of 008, at some level of significance to show the TGA that what we have is beneficial and is something new. Some new benefit (regression, slowdown of disease for example), doesn't have to be all, but does have to be more than one or two patients, has to have a decent enough P value.
We will need to wait for pivotal data here, it could be some (6 months - Interim data) months after last patient dose, it might be the full 12 months and then some compilation/summary time. After that we need to actually submit it, normally that's 220 working days....however, there are quicker pathways here too. Fast Track category also separately exists in the TGA Provisional world too and this process could just be assisted by what was announced today.
BENEFIT?
The benefit of Provisional application will be this:
All Docs over the entire country will now be able to officially prescribe iPPS. Sure many Docs will not have any idea about it initially, but mate, word that there is some new drug that's showing promise and alleviating pain and actually lasts for some time that's safe will spread.
Again I'm saying it may take a few months to rev up the revenue, but once word gets out, it will have a life of its own. There is a one large caveat here that I need to state. This wont mean that we can all necessarily retire on the spot. There will be, at that point no Government Subsidy, no PBS in place. So patients will have to pay the full fee out of pocket, numbers will be a bit tempered but I reckon many in pain and desperate for relief will come to this party. I've heard around10,000 full paying patients in the first full year is not impossible.
Insurance/Govt cover will only take place after full licence and that's subject to a Phase three completing successfully. There is a separate PBS application process to be followed here too.
Still lucrative, still good revenue....this is the next step I believe the company will and is following in this area.
Today's news is great in itself, independently of anything else, but it also has good ramifications for such next steps such as TGA Provisional and its this stepping stone that will be the start of more meaningful revenue in this area as another testament to what you and I own.
My views of course
- Mozz
But not unlike the company, we don't just wait and celebrate one train to push off, we have a few. This makes us a unique company and its only going to get more exciting as more programs come on line in the future (My views). Yes a real boost for us today and its comprised of two distinct components as we know:
1) DIRECT BENEFIT
2) INDIRECT BENEFIT
BUT..I'm already thinking of another catalyst somewhat in this space, in this line of thinking. What I want to set on my horizon is TGA Provisional. This should now be playing in the minds of the Par echelons....
We have clues already as to what the TGA want....they want something novel....They want something the market hasn't seen before, that the market doesn't have.
Paul mentioned PAIN reduction...and FUNCTION improvement (in the interview with Scott) ...there are various drugs that can lower pain... and others that can increase function... but are they safe? Does it last? Is it effective...well we know the answer to those questions...But what does the TGA want? They want something on top of that.
SO whaddya reckon, are we novel? What does the FDA say, Fast Track, that's a great additional start to us through the acknowledgment today of addressing the unmet need, addressing a serious condition......but the real test will be 008.
Donna and Paul separately gave us the clue. Paul mentioned that the TGA want something novel...and Donna also said the same thing more recently...novel, and a clear advantage over what's out there.
"It will really depend on how the data set looks and what the strength is around synovial fluid analysis as well as duration of effect". "We certainly will want to approach the TGA once we feel we have a strong data package".
- Dr Donna Skerret 2021 AGM
The novelty will be any whiff of DMOAD.
TIME?
Again on paper, not a quick process, first we have to wait for sufficiently good data to come out of 008, at some level of significance to show the TGA that what we have is beneficial and is something new. Some new benefit (regression, slowdown of disease for example), doesn't have to be all, but does have to be more than one or two patients, has to have a decent enough P value.
We will need to wait for pivotal data here, it could be some (6 months - Interim data) months after last patient dose, it might be the full 12 months and then some compilation/summary time. After that we need to actually submit it, normally that's 220 working days....however, there are quicker pathways here too. Fast Track category also separately exists in the TGA Provisional world too and this process could just be assisted by what was announced today.
BENEFIT?
The benefit of Provisional application will be this:
All Docs over the entire country will now be able to officially prescribe iPPS. Sure many Docs will not have any idea about it initially, but mate, word that there is some new drug that's showing promise and alleviating pain and actually lasts for some time that's safe will spread.
Again I'm saying it may take a few months to rev up the revenue, but once word gets out, it will have a life of its own. There is a one large caveat here that I need to state. This wont mean that we can all necessarily retire on the spot. There will be, at that point no Government Subsidy, no PBS in place. So patients will have to pay the full fee out of pocket, numbers will be a bit tempered but I reckon many in pain and desperate for relief will come to this party. I've heard around10,000 full paying patients in the first full year is not impossible.
Insurance/Govt cover will only take place after full licence and that's subject to a Phase three completing successfully. There is a separate PBS application process to be followed here too.
Still lucrative, still good revenue....this is the next step I believe the company will and is following in this area.
Today's news is great in itself, independently of anything else, but it also has good ramifications for such next steps such as TGA Provisional and its this stepping stone that will be the start of more meaningful revenue in this area as another testament to what you and I own.
My views of course
- Mozz