Question-and-Answer Session
Operator
Thank you, Mr. Babich. (Operator Instructions) Your first question comes from the line of Marko Kozul from Jefferies. Please proceed.
Marko Kozul - Jefferies & Company
Hi, congratulations on your recent progress.
John Babich
Thank you, Marko.
Marko Kozul - Jefferies & Company
John, first question for you, can you give us the sense of what was discussed in your recent meeting with FDA, specifically any clues that would suggest to reinforce that the Phase 2 BP-23 trial, I am sure there is one of the pivotal?
John Babich
Well, the BP-23 trial really serves as a completion of the Phase 2 development program, and I believe, from our discussions and I will ask Jim Wachholz to comment, but from our discussions I believe that we have shown unequivocally that Zemiva brings a clinical benefit to the triage of the chest pain patients. I think the agency is comfortable with that. Right now, we will be working with the design, the statistical plan for the primary endpoints for the Phase 3 program.
Jim Wachholz
Yeah. The meeting was really extremely positive and we are very gratified by the support that we got from Food and Drug. What we were looking for was their acknowledgement that we had in fact successfully completed the requirements of Phase 2 in preparation to progress of the Phase 3 studies and then we discussed with them the design of the Phase 3. And along the discussion was our position and the program that we had laid out for them, which is a single Phase 3 trial that will support the NDA.
So that's what we have been looking for all along, the large Phase 2 that we recently completed is a study that supports the single pivotal Phase 3 trial. And that is an agreement that we were able to secure at this meeting.
So we think looking forward it is looking very, very good for an NDA that will be based on a single robust Phase 3 trial.
Marko Kozul - Jefferies & Company
A quick follow up there, do you have any plan, future meeting with the FDA?
Jim Wachholz
We do not because we just met with them in the past week we do not have any additional meetings planned. We did discuss with them the possibility of additional meetings and we are considering that in terms of whether we will go forward immediately with an SPA proposal or whether we will met with them again prior to submitting the SPA. And those were the types of discussions that will be held.
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