TIS have been very clear about why they didn't seek TGA approval...

TIS have been very clear about why they didn't seek TGA approval in Australia. TGA approval would have not been accepted anywhere else and they still would have had to deal with Europe and the FDA. The CE Mark process was supposed to get sales going all over the world except the US and the approval would have helped with the FDA trials.

The strategy would have worked. I remember when we were told CE Mark had been granted, that a letter had been sent to TIS stating that it was all sorted, only for someone at BSI to start raising red flags at the 59th minute of the 11th hour.

Now we're dealing with EMA hoops and hurdles. An organisation that is happy to cause delays with no regard to the circumstances of the applicants.