Doesnt make sense. Interesting that TGA has said that HYD has...

Doesnt make sense. Interesting that TGA has said that HYD has until close of business 27th February to consider its response. It sounds like there may be some type of window for an appeal and clarification - and alternate pathways and options to seek approval.

I don't think this is a fait accompli yet.

Need to research if any other companies have been initially denied TGA approval then subsequently granted approval

Looks like there are avenues for review - first to the health Minister then a second option is to appeal to the AAT

There is still some life in this puppy

I think it is more likely they will eventually approve it based on the fact that it is already approved in the US by the FDA and in singapore and NZ. It is only logical that the same happens for Australia. This may be an opportunity to get in cheap after a slight hurdle.


https://www.tga.gov.au/resources/resource/guidance/guidance-requesting-reconsideration-initial-decision

Under section 60 of the Therapeutic Goods Act, a person whose interests are affected by an initial decision made under the Act may, by notice in writing given to the Minister, request the Minister to reconsider the initial decision.

Under regulation 48 of the Therapeutic Goods Regulations, a person whose interests are affected by an initial decision made under the Regulations may, by notice in writing given to the Minister, request the Minister to reconsider the initial decision.

Under regulation 10.7 of the Medical Devices Regulations, a person whose interests are affected by an initial decision made under the Medical Devices Regulations may, by notice in writing given to the Minister, request the Minister to reconsider the initial decision.

Submitting a request for reconsideration of an initial decision does not incur a fee.

Subject to the Administrative Appeals Tribunal Act 1975 - external site (the AAT Act), if a person is dissatisfied with a reconsideration decision made by the Minister, an application may be made to the Administrative Appeals Tribunal (AAT) for a review of the Minister's decision by the AAT.