mogwai...
Yes, I am happy on several levels, closing on a house sale Dec 2 and this will allow me to do a little Christmas shopping. I was very pleased to see this was Abrams himself that answered today and that means things are being attended to by our nationally acclaimed lawyers, who are not going to show any of that "deer in the headlights" behavior when confronting the FDA.
My contention has been that the original delay was related to the fact FDA was offering something significant and that rules out private lessons by the FDA on what is acceptable "off label" language. A further delay, sanctioned by our lawyers further confirms my opinion this also can not be an offer to peak at R-I results as some naive posters suggested.
I just can not think of anything else the FDA has to give us other than a label expansion or the SPA..So I may be ignoring something or just not thought of it, the those two items would be my number one guess.
":>) JL