PPS completed 12 injection course, page-61

Schmidlap,
Good question..I'll try and tackle the TGA Provisional approval question.

From my understanding IF we are granted provisional it lasts for two years OR until FDA/EMA gives it full approval status. The two years can be extended (up to 6 I believe in 2 year increments). Of course the TGA will monitor the approved drug carefully and will watch for AE's / problems while the drug is being prescribed.

The drug must come with BOLD inscriptions in the Personal Information leaflets when the drug is distributed. There are a few guidelines around this extra paperwork/rules see my link below. Its also a bit on a case by case basis so I guess with the extra paperwork and the Provisional program it probably stands to reason that it's not supposed to be a MASS roll out..more of a case by case thing . Almost like an application by patient? So to this extent I'm guessing doctors will be able to prescribe it at their discretion. The thing that may slow it down is the sheer demand once word spreads and the available supply/distribution constraints at least initially?

This is all my speculation and you definitely should do your own research as I might be wrong.

Here is a link for further reading which may or may not assist:

https://www.tga.gov.au/publication/provisional-registration-extension-and-transition-full-registration: