Called RAP yesterday, Tony Keating arrives back in Australia on Sunday. If substantial news comes out of the Creasphere digital health incubator I'd expect an announcement/ trading halt tomorrow morning. If it's more like an update on how things went and details on the specifics of the device for the home market then we would probably see an announcement on Monday as this gives more time to prepare an announcement and have it approved by the board...
It looks like the FDA is finalising the de Novo request as there has not been any further questions since before the AGM last year. I take this as a very positive signal. I think it will be finalised this month and I think we have a very good chance of being the world's first medically cleared, smartphone-based diagnostic tool for respiratory disease for sale in the USA. Such an ideal time to gather such a clearance. Telehealth, doctor visits in general and visits to the emergency department must be skyrocketing at the moment due to people concerned over whether or not they have the coronavirus when they have just got the common cold...
There are many informal discussions happening in the background that have obviously not materialised yet. It's good to know there's such a huge interest. I'm thinking once we have TGA clearance for adults and FDA de Novo clearance these discussions will more likely come to fruition...
Not long now folks the pointy end is exciting I want to see the chart go parabolic! A deal with Sanofi or FDA de Novo clearance will do just that
! A deal with Sanofi or FDA de Novo clearance will do just that
(20min delay)