Ann: Update to TGA Submission, page-184

I see some here defending the Therapeutic Goods Administration and who seem to equate the length of a permitting process with the thoroughness of a permitting process. As someone who in real life spent a considerable period of time directly involved in permitting processes my view is that efficiency and effectiveness usually work in tandem and a drawn out decision is more often than not a flawed decision.

The other observation I make is that credibility for regulatory bodies is a bit like virginity for human bodies. Both are lost in similar fashion and once lost it is irretrievable. Take the TGA for example ...

Have a read of this follow-up article from auntie about TGA's ruling on psilocybin and MDMA.

https://www.abc.net.au/news/2023-03-18/psychedelic-charity-accused-lobbying-tga-mdma-psilocybin/102103782

Here's a taste: "[The ruling] went against the advice from the peak bodies for doctors, psychiatrists and psychologists, respectively .... it went against the advice of the TGA's own advisory committee." Those sighs and groans you hear is the TGA losing its credibility.

Now I'm all for regulators being on the front foot and for them taking risk weighted decisions, but that approach must be applied consistently and universally. It should not take the involvement of opera singers and investment bankers and ex-cabinet ministers possibly posing under the guise of philanthropy and for the head of the TGA - who I suspect was not the decision maker if so should not have involved himself - to seemingly assist and coach the lobbyists for the TGA ro reach a risk weighted decision. The process should treat the hoi polloi and the hoity toity the same (I'm assuming here that the bulk of the holders of RHY shares do not usually rub shoulders with movers and shakers as these lobbyists do). Notwithstanding all of that I wish the outgoing head of the TGA, Prof John Skerritt, all the best in his future endeavours. Anyway, enough about the shrooms.

Given what I see as a lack of transparency and responsiveness from the company I will on Monday check out about kicking off a freedom of information request to see relevant documents about the the Colostat application with the TGA. In my opinion Rhythm got away with playing mum about the significant delays in landing Study 7 (which was due by the December quarter of 2019 but was only delivered in the March quarter of 2022) but I think the TGA process details may be more accessible. I will post on hc whether or not I pull the trigger on this one.