I've been through the experience with a number of companies. MSB...

I've been through the experience with a number of companies. MSB product designed for kids with the disease at one stage the FDA wanted them to try it out on late stage adult patients with a very low survival rate. They can easily change the goal posts to make it more difficult.
Not a huge fan of the company but it has a very promising product in an environment where there seems to be no reasonable alternative.

I am not at all experienced with the details of EBR product.

I am making this stuff up. But imagine that the FDA wanted EBR to do extra trials on people with sleep apnoea or epilepsy or late stage MS.

Maybe that's not a problem, I don't know.

Experience tells me to expect the unexpected.

I sincerely hope it goes smoothly. That's just something that I personally haven't experienced. Never had a company that wasn't required to jump those extra hurdles. Some got to the end eventually but time and money was a problem because of those extra hurdles.

But DYOR.

Cheers Lies.