Werble wrote 'TGA approval', not 'provisional TGA approval'...

Werble wrote 'TGA approval', not 'provisional TGA approval' which is different. Provisional approval has a maximum 6-year pathway and is dependent on providing additional clinical data to confirm safety and efficacy during the period. The good news for us is that if we get the required clinical data earlier then Zilosul gets expedited approval. DYOR

Source: TGA.
"Provisional approval allows us to approve some prescription medicines for a limited period of time while more research is conducted.We use the provisional approval pathway when a new medicine is a promising treatment for a serious or life-threatening condition but there is less research available on the medicine than we would normally require for the approval of a prescription medicine."

"When the limited provisional approval period is up, we review of all the evidence. If we find that the benefit of the medicine to patients outweighs the risks associated with its use, we give the medicine ongoing, full approval. If after the review, or at any other stage, we find the risks outweigh the benefits, we cancel the approval. If the medicine is cancelled, health professionals will discuss other treatment options with patients taking the medicine."