I think almost the opposite.While I have no actual idea and...

I think almost the opposite.

While I have no actual idea and indeed it could get knocked back, there are some curiosities about this one.

Why are they taking so long? It's a determination. Its like your end of Grade 6 applying with his parents to get into that prestigious school for Year 7. We are applying so the kid can firstly get in and then he will be allow to sit the Year 7 exams later on to see what stream he might get into in etc etc

FDA delay I get, there is a lot of data. There really is a lot of data and we have the propensity to positively affect millions of patients. This is a big application, it's going to indeed take some time.

In regards to TGA - I have checked the 5 entry criteria, we do pass them all, but you could make a slight argument for the 5th where it states that we should have a plan. ie a Phase 3.

This makes me wonder if they are waiting for the FDA to sanction our new Phase 3 plan. To sanction the MED.

It's possible this is linked?


So in other words we may hear back from the FDA before we hear from the TGA?

Would love to hear any of your or anyone else's thoughts.


I will anyway celebrate a positive FDA ann. I will be even more ecstatic if TGA give us an 'Eligibility for Determination' sticker.




DYOR (I could be totally wrong)