research reports and media, page-3318

I've been following TGA application since end of 2019. I got excited way back then cos I thought it was imminent.
Lots has happened since then. But now I think we are a good chance of being able to file it fairly soon.

One of the biggest things that has changed since the days of 2019 is the fact that the FDA now classify OA as an unmet serious disease. This helps us with both applications immensely.

The TGA want to see some sort of difference between just pain reduction and function improvement. If we can show that our drug does those two things AND some other meaningful action, like a reduction in a key biomarker that has the propensity to change the course of the disease at least in some worthwhile percentage of the cohort AND do that safely - well we should have a strong application.

To me, and it is only my personal opinions here, it would seem that some time shortly after the 6 month data observation on 008 would be a higher chance of being submitted assuming the 6 month read is good to great. PAR need to be careful with this one as its a one and done. Once you submit it, get topsetting wrong, miss something key, make an error, you have no recourse. You'd then have the forfeit the provisional TGA case and wait till FDA/EMA successful lichenising.


Definitely DYOR