Wednesday, September 28, 2016 1:17:29 AM
Look, I mean, am not going to discuss any details of the SAP on the call, but certainly really, the goal there was to make sure we got appropriate feedback from the FDA before we finalize the system analysis plan, which really is to make sure that the methodologies used for analyses around potential clinical benefit were correct and in line with the FDA, it was looking for. And we were able to get that clarified and really reach a really good position with them. And we are very pleased with the outcome of the meeting. It was very collaborative and productive. And I think both the FDA and Palatin are on the same page as to how the data should be handled and analyzed and methodologies that should be used.
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