Yes we are due a fair bit relatively soon.I suspect TGA will be...

Yes we are due a fair bit relatively soon.

I suspect TGA will be first and will beat the FDA in terms of timing...I could be wrong...that's how I would bet if this was a horse race.

I'm pretty hopeful TGA will go our way BUT I also am weighed down by the fact that we would be the first EVER indication in the inflammatory space under this Provisional Program and OA while it is definitely a Serious and Unmet need, isn't immediately life threatening. Though one could make an argument if you are in that much pain and loss of function over time and you need a drug to bring down the high level of pain and give back some functionality, isn't this vital? Comorbidities also result which only increase your chance of fatality! Isn't this the very spirit of the TGA's provisional program?

If you can't walk and exercise no longer, your prognosis is only going to deteriorate. What is QALYS then?
Let me just say, I don't know what the share price will do on green light but I'm telling you it will make a splash in the background...

Typically the market might yawn and say hey, where are the funds to continue? The market will groan and say I don't care that much about the data...I want funding to ensure continuity. But this will make a very material difference in any and all future discussions...this will add materially to validity.

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FDA I can understand that it's going to take some time...such a massive data set and with so many departments to consider it....it will take it's own time.
No news (so far) might be good news as it means there is nothing obvious we need to fix up, but then again would we hear of this? We will only really hear about it when there is something material that needs to be stated?


We can't do a lot but wait...




My views