Nah the TGA don't care (even the FDA don't care) about how the company is funded, they just concentrate and focus on their requirements which mainly revolve around the drug, efficacy, safety, therapeutic benefit etc etc. How the company generates funds is liquid is going concern is not their problem...
To reiterate what JamesTas said, we must get TGA determination first, if we are deemed to be eligible, we will then put in the full application for Provisional.
What does Provisional give us? Ability to sell in Aus WITHOUT advertising, marketing and insurance cover. No PBS etc. (that all comes after Full licence)
Timings?
Very hard to say, good to build in fat...but roughly...3 to 6 months to put in app. if we get a determination success (eligibility), about a year to get Provisional, it can be quicker...maybe 8 months as a rough?
Yes a longish time, but it will be real revenue after that...
Very much worth trying for this in my view.
DYOR
Where we at?, page-567
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