It is the same and I have ready reached out to the TGA on this and have posted their response in one of the other general discussions forums.
The summary the TGA gave me is that they are required to assess every application only on the supporting information the sponsor has submitted, regardless of whether another sponsor had already received an approval for the use of the same medical device.
They also indicated delays may be due to difference in lodgement times between the two sponsors, delays in responding to RFI where the application has been short on all the required info. It very much seems like AT1 has cocked up the self test approval process big time! IMO ofcourse
AT1 Price at posting:
16.8¢ Sentiment: Buy Disclosure: Held
