CE Mark approval for pediatric use was received on 23/8 and TGA approval was received 28 business days later on 2/10.
CE Mark approval for adults was received on 26/9, so 28 business days later is next Tuesday 5/11. I'd expect a Trading Halt next week for TGA approval for adults, like we had last month.
Morgans have indicated 4QCY19 for most of this year for FDA and also reiterated that guidance on the podcast that was aired today, with a possibility it could slip into the new year.
They were right with the CE Mark approval in 3QCY19, so given their conservative nature in forecasting, I'd have to say that there is a better than even chance of FDA clearance pre Christmas.
As for commercialisation, I would not be surprised if our first deal comes out of Australia, with a telehealth provider, off the back of TGA clearance for adults, which is due next week....
Upcoming catalysts, page-4
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #