Hong Kong provide approval based on European approval (CE marking) in this case. NZ and EU provided approval based on single arm study which means without comparing Oncosil with other product.
OSL maintained that their product is not replacement of any existing products but it is complementing existing Chemo Therapy...so for EU and NZ it was good enough evidence to approve the product.
TGA I suspect may be looking for comparison but I doubt it will be the case unless I see written correspondence from TGA requiring such data.
Next step is to wait and watch for me.. on how things go with sale in EU and HDE submission to FDA..
GLAH... brace for impact... !
Ann: OncoSil TGA regulatory update, page-14
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