Dr. Greg Demopulos: Yeah. Remember what we are — thanks, Serge. What we are going to be looking at as the primary endpoint is proteinuria data. So if those data are positive and we hope, and frankly, expect that they will be, but we need to see those data. When we see those, assuming they are positive, we would be moving quickly to put those data into the BLA. The safety data, all of the other components of the BLA are already being pulled together. So I think on timing, conservatively, I would look at a four-month to six-month timeframe from data to submission. But let me look to Steve and to Cathy to see if there are any other comments.
Steve Whitaker: No. I think we have identified everything that we go in the BLA and have plans together at all. So try to put in quickly.
Dr. Greg Demopulos: Thanks, Steve.
Cathy Melfi: Yeah. And
Serge Belanger: Okay. So you could have — go ahead.
Cathy Melfi: The topline data — once we have the topline data, that kind of what triggers the pre-BLA meeting with FDA and so I concur with the timing that Greg had proposed.
Serge Belanger: So there would be no issues in having two separate BLA filings, one for just the TA-TMA and another one for IgA nephropathy?
Dr. Greg Demopulos: Yeah. You are talking about, I think, resource allocation and workload. We — remember that we are looking for Q3 data on IgA. So we would expect that they would blend well. But, Steve, this is partly your group as well. So why don’t you address this?
Steve Whitaker: We have identified resources we need so they can run it fairly well and there’s overlap between the two as well. So I wouldn’t see any one blocking the other.
Dr. Greg Demopulos: Thanks, Steve.
Serge Belanger: Got it. And then a couple on OMIDRIA.
Dr. Greg Demopulos: Sure.
Serge Belanger: Now that the — you have gotten the milestone payments and the royalty rates knocked us down from 50% to 30%. Does that have any implication for DRI royalty agreements and respectively
Dr. Greg Demopulos: No. Not at all. Yeah. Let me just answer that first. No. I think our agreement with DRI, frankly, anticipated. Our success in achieving a milestone and DRI was and is very aware of that 30%. But we also — all of us, I think, DRI included expect overall sales to continue to increase with the legislative successes that have been achieved for all non-opioid pain management drugs and also as we start to focus on, I hope, Med Advantage as well.
Serge Belanger: And the last question, your partner Rayner now has a lot more visibility on the overall coverage of OMIDRIA. Do you expect they will increase their commercial support for the product going forward?
Dr. Greg Demopulos: That’s a great question for Rayner. I would expect they would. You now have secure long-term separate payment in the ASC. You also have HOPD payment beginning in 2025, January 1, 2025. That’s another 20% of the market. And so I would expect that they would be capitalizing on the broad support of the product and ramping up to do the same. But let me see, Mike, any comments on that?
Mike Jacobsen: No. I think, Rayner’s obviously looking at it, they are very aware that we have gotten the milestone and preserve the long-term payments and the HOPD side increases the potential there as well. So I think Rayner is really aware of the opportunities they have sitting there.
Dr. Greg Demopulos: There’s a tremendous opportunity as well on the Med Advantage side.
Mike Jacobsen: Yeah.
