Just putting this in perspective for those that don't understand...

Just putting this in perspective for those that don't understand - it is a tollerability study - nothing else. Nothing to do with the effectiveness of the product. Look at the power and method of this study for some hints.


As for TGA if you don't ask and design to solve their questions IMO you really do put barriers up in front of your self for timely conclusions.

So the question still stands unanswered if any part of the post market trial in UK SPL were forced into to continue to sell the product in UK is suitable at all in regards to a TGA application?

If it isn't , doesn't meet what TGA has asked for then in Australia you have no further progress since publishing of the June 22 tollerability study.

The question has remained the same for several years as why not conduct human trial in a format the TGA finds suitable for the application as a medical device or previously in the medicine catagory? SPL IMO had and has the $ but decided to spend it on lawyers and possibly not risk recorprical approvals it has received? What was the risk considering they were effectively selling stuff all volume, locked in with IMO poorly promoting distributers and spending more on lawyers while the time candle burnt at both ends- TGA at one end and looming post market study requirement at the other. All on a product that the company says is a no brainer from the petrie dish and animlas????

Love to have been a fly on the wall inside the tent with the financial modelling risk reward and product assessment that concluded risk of doing a human trial and being unrestricted in sales and advertising was greater risk / reward than selling stuff all product year on year , missing the COVID boom with govt support and funding etc against doing no human trial and instead awaiting time deadline for compulsury post market study that IMO may do little to support anything outside UK due to power and design?

Just my thoughts as I think the conspiracy chatter is very misguided at many levels along with lack of knowledge of process.

For shareholders sake I hope UK trial has been well managed and data is clean but why it is taking so long to process is mystery and the no communication from SPL IMO is poor form.