Skezan , many years ago I did a study when I was working in one of the University hospital in NYC , it was not for cancers .. I was doing dermatology then...

I still remember how much of work an explanation was between BP and myself to answered FDA questions ..

I had about 20 patients then , I can imagine , suddenly FDA want you to give them all for almost 600 patients ,
sometimes doctors may think they will do here or there fast , but it is taking a very long time...more than we all think most of the time...

Part 3 I dont know , but part 2 with almost 600 patients , I feel sorry what they going threw ,

I too hope that FDA considering approval also in mono , otherwise I will have no explanation as to what FDA is doing with us now ...

As always IMO only..