Hey Gal, you mention FDA for Prizma(OTC) and Patch. Agree 100%....

Hey Gal, you mention FDA for Prizma(OTC) and Patch. Agree 100%. I've been hanging out for these. And we must be close!

I see in the Outlook section on Page 3 the Doctor says the company expects to deliver on a number of objectives during the current period "pursue additional regulatory approvals for Prizma device and VSMS Patch". (NB NMPA is mentioned separately). Fingers crossed the Doctor is referring to FDA US. The timing looks spot on.

I went back to the Company Update 30 July 2019 :

"The Company is pleased to advise that no further clinical trials are required for the second-generation Patch, and that when approved will be one of the most advanced devices available on the market.The FDA approval process for Over the Counter(OTC) classification for the Prizma continues, and the Company confirms that no additional clinical trials are required." at page 5.

https://hotcopper.com.au/threads/ann-company-update.4880641/

Six months for FDA to approve a medical device - the timing looks spot on!

Needless to say, Prizma(OTC) in the US market will be huge, and Gen 2 Patch will light a rocket under our monitoring business/market share.

GLTAH!