Fantastic, PoPo! Fantastic.
Further to that, there are subsets and contingencies that are applicable on a case by case with the FDA.
As I have maintained, I believe when the news of approval hits, announcement of Orphan Drug status will be announced as well. No crystal ball of course but that is my educated WAG.
In consideration of the way the FDA process works, the rapid changes to the process that are being implemented, coupled with the fact that the company have provided all efficacy & safety data, we can be awestruck anytime now.
There is a bang coming. A very big bang!
BMSN
