All government departments/agencies have to comply with laws,...

All government departments/agencies have to comply with laws, regulations, rules, guidelines, policies and procedures. Some of these are available to the public, and some are intended for internal operational use only. From your previous statements you seem to have contacts in the FDA so I suggest you ask them rather than posters on HC.

I failed to address my previous post directly to you, so here is a copy:

You haven't answered my previous questions about how you know the FDA have serious concerns about the safety profile of iPPS, or why the reception was very, very lukewarm, but they decided to give it Fast Track designation - something reserved for new therapies showing safety, efficacy and superior treatment where there is a significant unmet need.

Maybe you have the courage to answer this one:

If there is a positive response from the TGA and/or the FDA will you apologize to Mozz for using him as your punching bag, or whatever it is you are up to?