TGA does give approval from data gained from either a EMA or FDA approval.
For this next trial to provide the required data, it will need a larger number of patients. DMD is a rare disease. So bang for the buck a trial in Europe/USA makes more sense. Does Australia have enough Patients to achieve the requirements for this trial.
Trials in Euroland or USA, if successful also allow Ozzie patients access to the drug with minimal delay.
Where others have failed will Atl1102 succeed ?, page-93
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