At this point NDA means little to this company for the following reasons.
Sales in the US, at best, would take another year to begin and would be slow in the beginning.
Americans can and are going to Europe for treatment.
What IS important is how fast sales will grow in Europe and elsewhere. If they double sales every month they will be in great shape. Even if they grow sales at 1.5 times per month would be great. Is that too much to ask as a goal for management?
Disagree on your comments regarding the US NDA. Even though the end result sales wise won't mean a significant change short term the news impact will be huge (my opinion) and perception drives share prices up. Guaranteed big jump on news on the NDA.