Yes, this is my understanding...
Similar to SAS BUT it would appear on a search by Doc's in their clinics looking for drugs that are able to be used for OA patients (under Provisional).
The thing in my head is that it's GREAT because we get first time sales.
This means look through, this means a sense of patient uptake rates, this means valuable feedback, it also means some sorta tie up with a distributional party to run thru logistics and the like. Its validation, it will be amazing.
How the garnering of the determination goes on SP? Meh.
But the background stuff will be terribly exciting.
Yes to answer your question, there wouldn't be any insurance cover and PBS etc.
That will come later after we get the full licence in Aus. (most likely when FDA grants us a full licence).
It then takes approx 6 months to separately apply for PBS in Aus.
I have little doubt we would get some fairly decent coverage/reimbursement levels once we are done.
PAR know this, they understand the worth of modifying our current P3 protocols to broaden the label if possible.
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