loulou, if you have not realized how expensive this gel is, it will cost over $100K/year in the US when approved. Most in Europe, where this has been approved for over five years, cannot get it unless they are either so bad off that it is cheaper for their medical system to pay for the gel than the nursing home/constant care needed (and that's pretty bad, very few qualify) or private pay, and who can afford that.

We were very excited this was coming to the US until we learned how much it would cost. I will be very surprised if any insurer will cover it, and most folks cannot afford it.

It might as well not ever be approved, if it is going to cost so much that 99% of the PWP cannot afford it.