Pacira Coverage: Expect the unexpected
Various Coverage for Pacira by Barclays, Canccord...etc
Below main points i would like to mention, which clearly shows that anything and everything is a possibility in the settlement with the FDA...i hope AMRN turn is next, 17th or before is around the corner;
Pacira got a new and better label
We picked up from the FDA website that Pacira has received a new label for Exparel and our interpretation is that a settlement is imminent. It's about as good as we could have hoped for.
In the updated label, the language was less restrictive
We continue to believe that a settlement with the FDA is likely to occur before the Dec. 24 deadline.
As part of the settlement, the FDA rescinded its warning letter that was issued last September. The settlement agreement clarifies that Exparel is “on-label” for a broad range of surgeries, not simply hemorrhoidectomy or bunionectomy which are a small fraction of Exparel’s current usage.
We believe PCRX was actually doing well under the restrictions imposed as part of the company’s original agreement with FDA after the warning letter, but this agreement provides the company with much greater latitude in promoting the product which we believe should be beneficial
We did not expect it, but PCRX did get language acknowledging its efficacy over 72 hours
We believe this outcome was as good as could have been expected when it was first disclosed PCRX and FDA were in settlement talks. It far exceeds our expectations for the outcome when PCRX filed the lawsuit in September in terms of both the terms and the speed that a favorable outcome was achieved.
