IFOBT is here to stay for quite sometime., page-24

Just one more reason to be irked with the TGA process .... Colostat was clearly not referred to in the ACMD meeting notes for Meeting 68, Meeting 69 nor Meeting 71. For whatever reason it seems we will never know if it was given consideration at Meeting 70 (see the snippet below). Meeting 70 was supposedly held on or about 8 December 2022. Why would the committee's secretariat just skip a meeting like that - even it they just submitted a blank statement or issued a note saying they all went off to the pub that day would be better than just pretending it never took place.

282 days or 194 working days - that is now over 9 months - since Colostat was submitted to the TGA. Un-f'ckn-believable! In their ASX announcement of 12 May Rhythm said they expected a result in 3 to 6 months!

https://rhy.irmau.com/site/pdf/5d91b0c2-b123-4462-b7a4-8af696077e2e/Completion-of-Final-TGA-Submission-Step-to-Approve-ColoSTAT.pdf

It all comes down to a binary decision, Colostat will either be included in the Australian Register of Therapeutic Goods (ARTG) or it will not be. It's down to a coin toss.

https://www.tga.gov.au/resources/resource/guidance/auditing-medical-device-including-ivd-medical-device-applications#s1b


https://www.tga.gov.au/about-tga/advisory-bodies-and-committees/advisory-committee-medical-devices-acmd