TGA has just denied a good treatment for Australian pancreatic cancer patients. The clinical trials first recruited Australian patients and they benefited from it. Patients were featured on the news. TGA probably is asking for comparative data between OSL device and other treatments available in the market which other regulatory bodies didn't ask for. Australian pancreatic cancer patients may have to go elsewhere for this treatment.
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Ann: OncoSil TGA regulatory update, page-13
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