MDCO
#Yes, <UNK>, thanks.
We mentioned it in extreme brevity just to not drag on, but it is going well.
By the end of this year, we will know if we have a Phase 3 product; and we'll know whether we are going to focus on conscious sedation or anesthetic induction or anesthetic maintenance, or some combination of those for the Phase 3 pathway.
So, very comfortable with the progress.
It is exciting.
But it's been rather in the back of the queue of late in our communications.
Apologies for that.
But happy to talk about at any time.
Yes, again, at the beginning of year, we said that one of our intentions this year is to find a partner for IONSYS.
It was a wonderful element of a hospital challenge strategy that the Company has changed.
We believe we can find a suitable home for it, and that it will continue to grow and be an important part of postoperative care in surgical units.
But not with us.
We'd still like to look at the data in that regard, and we will present the information in detail on the 17th.
But that still very much in the frame, <UNK>, for now.
Thanks, <UNK>.
Well, for obviously any drug that shows a mortality benefit with 95% confidence would be quite impressive.
Maybe less than 95% confidence might not be quite so convincing.
But, yes, sure, if you can show a mortality benefit it is going to be spectacular.
It is not part of our expectations, but it is obviously how the world may evolve over time.
So that's just to deal with that.
The longest we have patients followed in ORION I one is about 270 days.
There might be a straggler patient that's out to 300 days by now.
But then from the Phase 1, some patients don't see well beyond a year, year-and-a-half now.
But they were off drug.
So those are the sorts of time frames we're working with at the moment.
Yes, we are currently trying to figure out a way to do a nine-day week.
We think that might be at gating factor, if we get everything done.
But in all seriousness, <UNK>, there are no real impediments to this.
We've been thinking about this for a long time.
We have been looking at various ways of reporting this business separately for a long time.
We have carve-out financials and so on ready to go.
So I think it is just a question of execution sequence during the year and exactly what makes sense, in what order.
So I think particularly, now with the FDA well underway on the meropenem-vaborbactam review, the team has done an extraordinary job on that.
They are very focused on the launch prep.
So as long as all operation activity continues in such a good way, I don't think there are any particular strategic gating factors.
<UNK>.
Thanks, <UNK>
<UNK>, thank you very much.
Two very thoughtful questions.
I think with regard to cardiovascular outcomes trial with a partner, I think with without a partner we are going to do one, period.
We are set up to do one.
We think it is a critical component of value creation and value proof.
So, obviously, the beauty of having a partner is they would help you do that probably.
But we will do it either way.
As for why the regulatory agency chose not to undertake an advisory committee meeting thus far ---+ they can always change their mind, let's be mindful of that.
We are probably not the in the best position to replay that thought process.
We are very grateful for it.
It helps the priority review process go along.
Hopefully, it's a reflection of their confidence and the importance of the indication and the potential of the drug.
So I don't have a particularly good answer to that, other than we're very pleased to be moving swiftly in support of the FDA's review.
Thank you very much.
Thank you very much, everybody, for joining us today.
I would like to make sure that everybody is tuned in on the 17 of March to the ACC meeting.
Specifically as well, we're expecting to conduct a conference call at 3:30 PM the afternoon of the 17th, which is the earliest time we can do a public call following presentation of the ORION-1 results.
So we will do a webcast conference call at least at 3:30 PM on the 17 of March to cover the events of the day, in particular our own data.
Thanks very much, everybody, for your support and interest.
We look forward talking to you soon.
Bye-bye.
