The success or failure of the clinical trial depends on the endpoints formulated before you start the trial. The input of the TGA (or FDA, or EMA etc) in trial design is therefore essential. Starting a trial BEFORE you need to know what the outcome MUST be to get approval is irresponsible. It is a waste of time, money and would damage ADO's reputation as a medical device developer. ADO has been hit by shifting goal posts, that is disappointing, but cannot be foreseen in trial design. In my view ADO is absolutely correct in not rushing into another trial before getting the TFA on board on ALL aspects of the trial design.
Be patient and you may be handsomely rewarded.
Just my view.
The success or failure of the clinical trial depends on the...
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