using because it is safe!!!, page-8

With respect i think this has been covered before.
The FDA prescribed clinical trial , with diet and exercise and MBP botched lead in, see JV previous post re flawed trial,killed off any chance of statistical significance and hence the holy grail, bonanza, of access to the US market was lost.
One can only speculate on a more modest aplication to the TGA.
If the high powered , well remunerated board , with all the letters after their names, cant bring a succesful laboritory candidate to market what chance the current.
GRAS makes sense.
There is a considerable amount of free publicity at the moment and if only there was some way to capitalise on it. Perhaps a web site where expressions of interest could be made for pre purchase. It could be added to a marketing package if succesful.
I met Frank at a AGM many years ago and he impressed me with his belief.The body language when some board members got into the lift was interesting.Somewhat strained. I walked with him to a tram. He gave me a note with POH . I await patiently for developements there also. Esra had collaborated with him at Monash prior to POH.