I think they should have commissioned a clinical trial rather than an application to the TGA. Probably a balance between time critical panic to release within a pandemic. Clinical trial would have taken longer, but proving efficacy to the TGA without one in the context of the product would be difficult. But that’s bureaucracy and red tape. You can prove the substance in the product kills COVID but you can’t say it does on the packaging.
imagine trying to demonstrate efficacy of a balm applied in the nose. You would need people to use it, and then try catch COVID against people who haven’t used it. In top of that the study pool is now terribly complicated by high vaccination rates. You would need to use unvaccinated subjects to distinguish between the efficacy of the balm and the efficacy of the vaccine.
Not ideal by any means, but better to release it than not. Let the buyer decide. We would have crucified them if they kicked this down the road again.
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I think they should have commissioned a clinical trial rather...
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