Will TGA have to consider another nasal spray trial?, page-12

Again a misguided post full on incorrect assertions and inaccuracies

What you have described is not how the system works.

Approval to manufacture and export a product for a different world market has nothing to do with its efficacy only that it is being legally manufactured and they are doing it as specified.

The Viraleze post market study failed to meet its endpoint - yep failed.

I think shareholders really should consider when the market and SPL knew that any data from UK post market would not have been acceptable to TGA? Should shareholders have been told something? Did the TGA ever say they after looking at trial design etc ever agree that the data would be sufficient to support TGA ? Did SPL include everything the TGA requested in that trial and what were the definitive hurdles?

Your understanding of regulation and FRE product let alone world distribution and what countries require registration is severely lacking.

By the way still awaiting an apology for your vile unfounded outbursts on other threads related to your claims that posts were not AI generated- had a epiphany yet or a sense of morals and ethics?