That is exactly the case - and recall Dolphin 5 or 6 years ago advising not to expect significant sales or uptake until controlled studies were completed and published, and that's when the company started the push for the necessary clinical studies (which many holders railed against). Many controlled clinical studies were initiated during that period (burns, scar, ulcers, aesthetic) which are now being published or nearing completion - and are the future of the company. They won't need to be repeated.
FDA clearance is, of course, the largest and most stringent test of those controlled studies. So no, other countries don't rely on FDA clearance, but when clearance is granted (and it will be!) the fact that the product has successfully undergone such rigorous testing is massively important throughout the medical world and the sine qua non for a successful commercial medical product.
Add to My Watchlist
What is My Watchlist?
