I'm genuinely interested in this, not trying to make a point. As...

I'm genuinely interested in this, not trying to make a point. As I read it, this could change the design of the trial(s) that OSL have to do to gain FDA approval for their device. However, they still have to design the trials, and then conduct them. What is the real benefit to OSL in this announcement? Does it speed up the FDA approval process in terms of weeks, months or years? What are people's honest estimates of how long FDA approval should take, from here, taking today's announcement into account? Also, if the CE mark is NOT granted, and I think that still has to be considered as a possibility, even a very slim one in some people's opinions, do you think that the FDA would ultimately grant approval for a device that the European Union had declined to approve? The FDA has always been considered to be the hardest regulatory nut to crack in terms of medicines and medical devices. I understand that it looks like they're making the process a little easier for OSL, but it's still going to take years from here isn't it? And there is still no guarantee that OSL will ultimately be successful in gaining FDA approval? Unless I'm missing something.