RE:RE:RE:RE:question for those in the knowMany thanks for your explanation MM. Makes complete sense. Yes, hopefully the US relaxes their ultra-stringent process and Spectral's application is approved pronto.
mercedesman wrote: "how it was approved in Canada already but is taking so long in the US. I am trying to understand the differences between the countries." Imatryin
The US (FDA) has the most rigid standards in the world. Canada takes queues from US FDA approvals but does not otherwise abide by the same standards. Note that PMX has been used in Japan and Europe for more than a decade. In that sense Canada is more like Europe...or perhaps more correctly - somewhere in between.
I woudl also note that the US FDA has apparently been under some pressure to move away from the rigid 28-day mortality statistical requirement when it comes to approval of drugs and devices relating to much more complex deseases (e.g cancers and Sepsis) with diverse populations (that can perhaps be better stratified as to treatment course, with the advent of biomarkers)
What Canada needs is a canadian champion (e.g a Ronco type) coupled with a Distribution Partner (announced today) with some marketing $ put behind it.
MM