PGNX
#You mentioned EMA, <UNK>, did I hear that right.
Yes.
So, yes, we first got the drug as we acquired Molecular Insight.
This trial had been underway, as you know, with Molecular Insight in the US, but they had stopped it.
So our initial focus was getting this back up and running in the US.
And the team did a great job with that.
We have great manufacturing in place.
And then, this amazing Breakthrough Therapy Designation.
One of only 90, I'm told, that have been given in the US, with over 300 rejected or not approved.
So I think it's a quite-significant accomplishment.
How do we take it forward in Europe and in Asia.
You know, I've spent time in Japan where [FEO] is an important focus in Japan.
So we're looking at different alternatives.
One would be to work with partners in each of those areas.
The manufacturing could be done centrally, through our manufacturing site in Ontario; or we could distribute the manufacturing throughout the world, working with radiopharmaceutical manufacturers.
There's so many good ones in Europe, and we see them emerging in Asia.
So, that's high on our to-do list, <UNK>, but I don't have more to report than that.
Yes, I don't think, <UNK>, that we have a lot of detail there.
We have the statements that Valiant made in their quarterly call as they talked generally about what was happening with their drugs.
And we have had discussions with the Relistor commercial team about what's happening with Relistor.
I think, broadly stated, what they say to us is that they feel this quarter's sales were impacted by the inventory runoff, if you will.
But despite that, we see $11.9 million in sales.
So that's coming back to the run rate that we'd seen at Salix before the Valiant transaction.
They feel that there will be continued impacts, although diminishing over time, basically for the remainder of this year.
So I think we don't have more specific details than that, <UNK>, but we see Relistor coming out from underneath this inventory problem.
I was pleased to see us get to almost $12 million in sales this quarter.
And we would hope that as the inventory continues to run off with other wholesalers, that that will have a positive impact on sales.
But that remains to be seen.
No, we find Valiant is still thinking through what is the best approach there.
I think a primary decision for them to make is, are they going to market it themselves using their existing capabilities in Europe, and perhaps enhancing them because of the potential for Relistor.
Or will they want to partner with a company or companies in Europe.
The Relistor submission needs to be changed from a FDA submission to a European submission.
That will take a matter of months in order to have that change made.
And then we would expect that to be submitted.
That's our understanding.
The EMA has never been concerned about the cardiovascular risk, which was a concern at the FDA and held us up for a period of time at the FDA.
Now I think we're past that with the FDA.
That was never a concern at the EMA level.
So I think we have a good package for the EMA.
But as I say, it needs to be converted into their format before it can be submitted.
Thank you, <UNK>.
Thank you, operator, and thanks to everyone joining us today.
I just wanted to make a quick announcement, to stay tuned for details on our upcoming R&D day, which is planned for October 1st in New York City.
We'll be featuring thought leaders in pheochromocytoma and prostate cancer imaging, and we'll be reviewing our internal pipeline programs.
We'll be providing additional details in the coming weeks, but we'll hope that you will be able to join us on October 1st in New York City.
Thanks for your attention today.
