Yeah here is my theory on TGA...not dead, not buried, still has...

Yeah here is my theory on TGA...not dead, not buried, still has pulse..



The TGA Provisional has predominantly been for drugs in the therapeutic space of mainly oncology, infectious disease and the odd haematology drug.


I went onto their web site and made a brief list of the main provisional applications they have had in the last couple of years, it looks like this:





Certainly nothing in the inflammatory or musculoskeletal area !

Now just because there is nothing in our therapeutic space doesn't mean we don't stand a chance, in fact quite the contrary, they may take the view that something is sorely needed here. At the same time they will be cautious and will need to see some decent evidence before allowing us to hyper speed into possible sales...

The problem with the TGA Provisional program is that it is one and done. If you apply and something is missing or some detail isn't quite exactly right, there is no re application process....that's when you ARE dead and buried, at least until you come back to life only after and until you get a full licence from some other authority or apply to the TGA for a full license. (That's not happening till our P3 is done and we have an NDA).



ELIGIBILITY

This from the TGA website:

So the above certainly gels well with what we have...Major therapeutic advance is the clue and this is why I personally suspect PAR are waiting, otherwise there is no doubt they would've put this in already by now. 6 month data is good...12 month showing further or continual separation and signs of structural and bio chemical markers compared to the placebo group will elevate our standard enough to pass this test. That durability aspect is going to mean a lot to the authorities.


SO we have indications that the TGA want something from our drug that isn't already out there, ie it cant merely address pain and or function despite it having the safety profile of no other....

This effectively means we need to show DMOAD connotations and not just over like a 6 week period. I suspect it has to be over the full 12 months and then we have a shot at this. It will take some time and it may even require the Minimal Effective Dosing to be first determined before we can apply?


PROCESS

Once we are in a suitable position to apply...we put it in, we wait for the acceptance and then the real process starts, 250 statutory days but the problem is that that isn't calendar days...its working days *sigh*.

However, there is a Fast Track program which will cut around 50 maybe a few more days off that (my views). I think certainly it is worth applying for when they are ready - they really need to be ready....I also think there is at least *Some* chance of us perhaps getting some faster pathway in other parts of the world and this TGA Provisional application may become somewhat of a mute point anyway... I certainly am not personally weighing it in too much though I am allocating at least some chance of faster pathways.

If we get a licence from one of the major other authorities, I then think there is a chance the TGA will just allow us to sell here in Aus on the back of that submitted data even if we have something in progress with the TGA already. Certainly the application and acceptance of a TGA PA will be viewed well by the market when it eventually gets submitted.


DYOR required




- Mozz