Ann: TGA Registration Update, page-202

opel i am not of the opinion they stuffed up at all. When you read the announcement slowly and carefully you can see that clearly the TGA moved the goal posts after the submission (also i suspect all the negative media attention did not help)... then have requested further direct patient test data. "direct patient samples, and the TGA’s requirements for additional clinical evidence.. i see no evidence anywhere that says Anteo failed to give the information required rather that TGA wants additional data as they may not have been satisfied with the VTM inference sample data.

The wording used here imvho shows Anteo being very "supportive" of the TGA and their "constructive discussions" almost sucking up to the TGA.... it also seems as though Anteo were the initiator for the further clinical testing ...
"Following these discussions, it has been concluded that AnteoTech’s proposed approach of conducting new clinical
trials"

Another thing to note is that when/if Eugeni is approved it will be used in a clinical setting so the TGA needs to be 100% sure that when they approve this system... yes a SYSTEM... it works properly... this is not a home test kit with Zero ramifications if it doesn't work....

The frustration from shareholders over how long this is taking is very real... and i fall into this camp as well but i would like to highlight an application to the TGA that i know of that will highlight their sometimes lack of speed or goal post shifting...

Many, many years ago, early 2000's, there was a sunscreen that took over 2 years to get TGA approval... this was way before any of the "save the reef" ingredient changes were required. It was a simple sunscreen no different to the ones made locally... they changed the goal posts so many times to protect the local products it was a joke.. i know this because i was trying to become the local distributor... needless to say i gave up ..

These guys are not squeaky clean imvho.. am i frustrated ? hell yeah! Do i personally believe the goal posts were shifted ... 100%... Why is the million dollar question... was it because they realised this will be a clinical system that will most likely end up in every hospital and doctors suite and therefore upped the criteria.. or was it for another reason ? guess we will never know..