Stephen Davis at 2020 Stifel Virtual Healthcare Conference
"And just as a brief reminder, our sNDA submission included an efficacy package, which was agreed upon with the FDA at the end of Phase II meetings before we conducted the pivotal HARMONY study. And based upon the robust and meaningful results from HARMONY and this additional supporting data from other efficacy studies in Alzheimer's and Parkinson's patients and then just the overall safety profile of pimavanserin, we remain very confident in the potential approval for DRP.
So, again, just as I put it – with that backdrop, at our end of Phase II meeting, we went to FDA. We said, we think we have demonstrated sufficient efficacy in acute setting. We would like you to agree to three things. One, that we study DRP generally. They agreed to that. That was actually a very short discussion. Two, that we run a relapse prevention study now to demonstrate the - not only that we can stabilize patient symptoms, but that we get a durable effect over time. And then three, that we – that a single relapse prevention study serve as the basis of approval together with the other supporting acute studies we’ve done. And they agreed to all three of those. That's documented in our minutes.
So fast forward to today, we then executed the exact plan that we laid out for them. And again, that underlies the confidence we have in the potential for approval in DRP."