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Re: Gramps post# 80491

Saturday, 07/23/2016 2:33:03 AM

Saturday, July 23, 2016 2:33:03 AM

Post# of 329068
>>>....I take this to mean that they are covering their bases with this third study and are very close and ready to make this happen because the studies have been more than acceptable to this point. And they are moving fast on communicating with BIEL between meetings which is a huge point to draw out. No more hoops for BIEL to jump through. The FDA is clearly on-board IMHO.<<<


I totally agree with this assumption. I really don't see how anyone can interpret this any other way! Why in the world would they ask for another study if they were not leaning toward approval? If FDA mindset was negative, this would be stampted "DENIED" right NOW. --- Just need a little more historical data to back up their: "OK, GO FOR IT"!