Well I don’t know Blue … all I know was what SUD reported …...

Well I don’t know Blue … all I know was what SUD reported … which was the TGA had questions related to the control section of the application.

The resistance problem has been discussed on here before. Artimist is a sublingual version of artemisinin and is a monotherapy. And the WHO doesn’t like artemisinin-based monotherapies.

“One of the most urgent challenges is to strengthen pharmaceutical market regulation, and remove oral artemisinin-based monotherapies and substandard medicines from markets around the world once and for all.”

https://www.who.int/malaria/media/artemisinin_resistance_qa/en/

Lets go back 5 years. On HC I posted that Artimist was a monotherapy and suggested this could be a problem. Kippax posed this issue to SC and kindly posted the reply.

“I asked SC the very same question about monotherapy treatment in January this year and did post the following response.

"There is no concern we will be specific in what we register the product for and that will be the treatment of uncomplicated or severe malaria in children with gastric complications (virtually most of the kids)"......

https://hotcopper.com.au/threads/abc-qaeda.2003824/#.XL0K4DAzbIU

SC avoided the question. You can be as specific as you like about the indication but this doesn’t address the control concern around resistance. A bomb has gone off in exactly the spot a bag was left unattended. That was enough of a smoking gun for me I suppose.