This is my opinion/viewpoint, only. The TGA have the criterion...

This is my opinion/viewpoint, only.

The TGA have the criterion that requires PAR to demonstrate they have a plan to provide further clinical information (Phase 3) within a set time period. We cannot satisfy that criterion unless we get the green light from the FDA. I would imagine the TGA do not want to open the gates to drugs that are not fully tested and proven, unless there is reasonable certainty that the proof is in the pipeline.

Even though we are only asking them for a determination to proceed with an application, and not for provisional approval at this point, they would not want us to proceed with an application if there was uncertainty about our ability to follow through with the necessary further data. As public servants with a duty of care to the welfare of the Australian public and the revenue provided by the Australian taxpayer, they could possibly see PAR's financial position as a matter for concern also.

In the same way a bank does not (normally) provide loans unless you demonstrate a capacity to repay, the TGA don't wouldn't want to allow experimental, albeit very promising, drugs into the market unless PAR has the capacity to complete the trials.