Replying on this thread I had a bit of a look into this. We said in our 4C that we submitted Provisional Determination "at the end of June 2024", lets call it the last working day being 28/6. On the TGA website they say "Our target timeframe for assessment and decision making on your determination application is 20 working days." As of today we are at 33 working days from 28/6 (allowing for one public holiday in July), so pretty significant additional time beyond target. You would think if there was an issue it would have been flagged by now. Looked in to that Criterion 5 you mention as well which says You are required to provide sufficient evidence of a clinical trials plan to submit comprehensive clinical data on the safety and efficacy of the medicine within the provisional registration period. Seems possible that a condition for giving the nod for our provisional at 2x2 is that we will be able to provide data for the same dose from our final trials, hence maybe waiting on FDA response that we can proceed with 2x2?
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