Firstly is TGA considering a Sched 3 review to allow...

Firstly is TGA considering a Sched 3 review to allow Viraleze?

Does anyone know the TGA Processes Viraleze as a medical device will go through. Medical device as opposed to medicine was determined on appeal to adjudication by Starpharma Feb 2022. Starpharma reported to ASX that they had a medical device application in with TGA in March 2022

I understand that there is no requirement for prompt or defined timeline processing by TGA and we saw reference in Sept 2021 in Michael Pascoe New Daily re RAT Approvals that TGA waits for THE signal of HEALTH Minister (now we know pre ALP that was not just Hunt but also Morrison)

For Astodrimer Sodium Sched 3 review TGA required a Delegates report which appeared in March 22.
https://www.tga.gov.au/sites/default/files/notice-interim-decisions-proposed-amendments-poisons-standard-acms-accs-joint-acms-accs-meetings-november-2021.pdf
… and was 4mths after public consultation via online survey which was advertised. Then subject to a final review if the sponsor was unhappy with the delegates Draft decision. So the changes to astodrimer in Sched 3 took 6 months. As the last review of astodrimer was specified as only VivaGel BV usage and permission to advertise - do we assume that approval of astodrimer as nasal spray Viraleze medical device will need a similar Sched 3 amendment which could need to start with public consultation and thus take 4 or 6 months??Anyone know if this is a likely further delay