Ann: PAR to present at NWR Healthcare Conference, page-23

Yes and the fact that the 2*2 twice weekly wasn't included in the dosing arm study speaks volumes about how the FDA viewed the safety of this dose. There is absolutely no reason not to include it, and to rely on a previous smaller and less controlled study, outside the jurisdiction of the FDA creates risk.

So to say 2*2 is a shoe in is not true - and the fact that PAR did further PK and non-clinical studies last year in the background attests to this.

It seems the January meeting with the FDA triggered a range of questions from the FDA that PAR is scrambling to answer.