Good question Mr Huts...I believe they prob won't take it into...

Good question Mr Huts...

I believe they prob won't take it into consideration. Each and every Provisional application would need to stand up on it's own merits and follow the 5 published hurdles (see at end of this post). There is maybe some small chance they may cast a more cursory eye over the data but they won't consider it really, my thoughts.

The reason is that it is certainly not well controlled, double blinded etc. They will want that sort of well controlled data but they also infer we don't need oodles of it....


"For a provisional determination and subsequent provisional registration application, the clinical data available may be limited".^*


They want 'preliminary clinical data'.^* This doesn't mean masses of it. In other words our 005 should suffice, possibly some part of 008 will also be used in the initial determination dossier.

I wouldn't be surprised if this still takes a few more days to play out...there is every chance that there may have been some to'ing and fro'ing.

The legislation allows for it over and above the 20 stated Business days.





My personal views, no advice, don't rely on just one poster's opinions etc





REF: * https://www.tga.gov.au/resources/resource/guidance/provisional-determination-eligibility-criteria