I have basically the same questions that you do....
I spoke to Dr. Y right after the "approvable letter", and his statement was that the Activ-L study would start with the one level segment, and then proceed to the two level segment at a later (undetermined) date. (
I haven't heard anything about waiting to release both the 1 level and the 2 level at the same time..)
But, as you state, it is now nearly June, and we still haven't heard anything from the FDA concerning Prodisc (although Dr. Y did think that something related to Prodisc would be announced during the SAS 6 [which, of course, didn't happen]).
So, here we both wait, wondering when something
might happen....
Edit: Ultimately, I wish I had
some information. If I had any kind of time-line to look forward to, then I would have a goal of some sort. Since I don't, I am seriously thinking about hopping the big ocean to Germany for surgery....
David