The answer is lengthy and not straight forward. At the end of the day, it depends on the data. A number of pathways are possible and again, all hinges on the strength, consistency and significance of our data. Needless to say safety profile too.
Just as an example, this is only my spec thoughts and certainly doesn't cover all possibilities.
Most difficult pathway, the FDA makes us do 002 and 003 and then we have read out. Our pain and functions observations, on the proviso that the data is good, is consistent and Serious AE's are nil to very minimal, we are eventually allowed to sell. DMOAD is a separate issue and requires us to formulate another study that's longitudinal in nature. Yes a few years. But the DMOAD pursuit will not delay 002/003...Don't forget, we don't need full proof that there is DMOAD for every patient to submit a TGA Provisional Application, we'd only have to show some notable and beneficial difference between std of care (other than pain and function)...there will be a degree of significance here...again, may need to wait for 6 month data?
A mix, we are an AA and TGA Provisional possibility, still need to do a separate study on DMOAD specifically but we are allowed to start early and must complete the 003 (confirmatory) trial.
The most opportunistic scenario, the data obtains so far is great, it links well with what is being observed in 002...the authorities are happy with surrogate biomarker observations in 008 human, 008 canine AND what's coming back from 002. May still need a separate observation to strictly place DMOAD on label.
Now with the Green light there can be hurdles and I'm not at all saying this is going to happen NOW...lets not go crazy here, it still could be a good year, maybe more time away?
There could be multiple combos of the above...again, depends on many factors.
One thing that gives me some enthusiasm is that the data so far is looking good (observations of P2 B, SAS and other supporting studies like RRV, Heart (Pre clinical) etc). The MOA is outstanding, the safety profile is established. This is a great start for us.
Worst case we are a few years away..best case......? Mate.
The other thing we forget is that yes, it will be a glorious time for all of us when we get DM on the label. High fives and cake all round..(maybe the odd beer/champers)....BUT guys, isn't there a possibility of off labelling, word will get around, all we have to do is be allowed to sell into these gigantic markets. DM may take its own time before we get the large step up in pricing and volume but off labelling volume may just allow us to celebrate anyway.
Donna was asked this question in the webinar back in July.
When would PAR go to the authorities in terms of an AA and/or Provisional TGA, she commented that it..."...really depends on what our understanding is of the data ...and 56 days compared to 6 months".
She goes on to say that ultimately we will discuss with the authority putting a harmonised trial together to show the long term effects.
As Donna stated when asked what is required in terms of getting a DM on our label....
"...that may be acquiring new data or acquiring new pre specified data analysis with pre existing data".
SUMMARY
In just my own view...I think there is a chance of a faster pathway certainly to start selling, I am conservative, I would say end of next year...but who knows. If you were realistic, you'd have to wait for the data, top line is one thing, 6 month will be more telling. You'd also wanna watch top line 002.
The bit that excites me the most here are:
1) Canine Study to enhance longer term observations 2) 6 Month DMOAD coupled with top line 008 observations 3) Top line 002 as it is linked. How is it Linked Mozz? Via all the added observations in 002. These are mainly structural but there are exploratory observations that have been added including but not limited to Synovitis, effusion, rescue observations along with the (many) structural observations.
Yeah, DYOR as usual, just my thoughts, could be spec. in nature.
(20min delay)