It's a tough one as theoretically the steps are:1) Review...

It's a tough one as theoretically the steps are:

1) Review Application - target is 20 Business Days. We are applying for a Determination of Eligibility for a Provisional License.

It's been more than 100 Business days as far as I can roughly calculate. It is only a target though


2) Once and IF we are accepted, then its a statutory max of around 250 business days for the TGA to process it but they try and do it much quicker, around 150 to 200 days.

The clock starts from when we formally put in our application, which could easily take 2 months plus or so to compile it all.


3) If we get it, we can sell under a Provisional licence.

That's roughly as soon as Mid next year, maybe late next year if you are conservative.

But we have to be deemed eligible first. When would that happen?

How long is a piece of string. I suspect they too are waiting for FDA IND open?? This would give them certainty that we have a P3 in motion (within 6 years according to their rules) and all has been accepted.