RE:RE:Australia and EU
Dividendspay wrote: I am familiar with the European process, although have much more experience with the FDA.<br /> There is quite a range depending on how the device is classed, and the complexity(can be a few months to over a year)<br /> In terms of approval, my prior comments on the board regarding the US process apply here.<br /> I would not be optimistic. <br /> One never knows until the reviewers decide, but I suspect they will follow the US<br /> Still, my thoughts here, and anyone's are speculation and I wouldn't invest or not based on what you read here.<br /> The only area Ifelt confident witH, as stated in my earlier post, was the interpretation of the Clin ical trial results, as being non significant
The Company has withdrawn its application from the EU marketing process due to uncertainty in Europe due to the switch from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) and the withdrawal of Lloyd’s Register Quality Assurance, the Company’s notified body, from the notified body business. The Company will reconsider submitting to the EU when conditions stabilize.
Read more at https://stockhouse.com/companies/bullboard?symbol=hsdt&postid=30414575#7H0jdpSEkV2tWq1p.99
As expected
I was pretty certain of the FDA and EMEA/Europe outcome
This wasn't that hard to predict if you know how to evaluate clinical trial results, and can apply the regulatory bodies typical approach.
For some reason, many believed the negative results were positive.
Facts matter.