“The TGA has discussed the differences between a medicine and...

“The TGA has discussed the differences between a medicine and medical device with Starpharma verbally and in writing on several occasions, as recently as mid-January 2022. To date, Starpharma has not sought advice from the medicines authorisation branch of the TGA nor have they submitted an application for this product to be included in the [register] as a medicine.”

Starpharma has NOT sought advice from the medicines authorisation branch of the TGA. They have also discussed the issue both verbally and in writing presumably over the period since the application was submitted over 6 months ago or even beforehand.

Having read the article and Starpharmas response l can only draw the conclusion that JF & co are not up to the task. This has clearly been an issue from day 1. Why in fact have they not sought advice from the TGA's medicines authorisation branch. I would have thought this would have been number 1 priority prior to formal application for approval.

What l wish to know has the application advanced with the issue of device or medicine only to be resolved or is it stalled in the starting blocks. I would have thought this should have been noted in their ASX announcement as a priority.

As @col69 has already mentioned disputes with 3 regulatory bodies in 3 countries is surely a reflection on our management.