Agree with entdoc. No way that Garnick has not put out feelers with folks at the FDA prior to releasing a PR like this. With all the Class Action Suits lined up, these guys would be out of their minds to put out a PR like this unless they had good reason to believe a Phase III approval from the FDA was a reasonable outcome.
I agree Entdoc.... Garnick knows what he is doing. Hmmmm... that just may mean King knew what he was doing when he brought Garnick on board.
"mos" and "safety" ... thats how the discussions will begin with FDA and BP's .... yes, lots of middle ground statistical talk.... and the deal is closed with "mos" and "safety" that Bavi brings to the table.
I think there was a reasoning behind running trial after trial after trial with Bavi.... the common theme will be "mos" and "safety"
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