TGA and other Countries Authorities is a process. All biotech...

TGA and other Countries Authorities is a process. All biotech know the process and seem to be able to navigate it .
SPL probably IMO for reason of classification or lack of data human study/ trial etc are stuck in that system alothough IMO through multiple pre lodgement meetings an dsubsequesnt application should be in no doubt exactly where they stand - shareholders are not afforded this information unfortunately to be able to assess that information.
I do not understand why SPL has not done study on humans and used Flu for instance ( low risk to participants) to show it works , how it works and then they have a platform of data that can be combined with their invitru in regards to SARS Covid.

You say rolled out in Japan? Did I miss something? I didn't know there was a distributer ? You mean IMO avalaible in Japan under a general exemption for private import?

"Any TGA readers Just think about that the fact its rolled out in Europe ,Japan and Vietnam soon to be in other Asian nations like South Korea."

South Korea? I don't know much about Medicines and Medical devices in South Korea. I believed they followed USA lead with many . Have you done any research into it? Other Asian nations area mish mash of rules and regulations or lack of so it may not be as straigh forward as we think.