CELG
#Thank you very much, <UNK>.
I can't thoughtfully respond to the first part of the question because the study is not completed and I haven't seen the data.
It is not unusual for large studies to have protocol amendments and some minor changes to plans and things during the course of the execution of the study.
I've never personally been involved in a study that had no amendments at all from start to finish.
So, some minor amendments can happen for a lot of different reasons.
Specific to this case, the study is not complete, I haven't seen the data, so I can't thoughtfully comment on whether there's anything there which would lead us to change.
But at this point we don't believe that there's anything that we see that would lead to major changes in the program.
Relative to what to expect, this is where it's a little bit different to take a look at comparables in the external world.
Very few other companies use SES-CD as the main endpoint to look at endoscopic healing.
There's been an evolution in time on what endpoint you should use.
Some of the older studies have different endpoints.
And the other thing that I think is very important when you look at the data from GED or any new entity in Crohn's disease from this point forward, is we're starting to do baseline endoscopies so that we can confirm that there actually is mucosal involvement at baseline.
The prior studies didn't do that.
Some of the patients didn't have any lesions when they went into the study, maybe didn't have Crohn's disease.
And that was one of the development challenges with Crohn's disease.
The way to get around that is to confirm active disease at baseline.
This is a little bit different study.
It's more rigorous from that perspective, making sure that there's mucosal involvement and mucosal damage.
And then taking a look at, with the SES-CD endpoint, which is different than endpoints that have been used in the past.
So, it's a pretty stringent study that's going to give us a really good idea of what's going on in terms of not only signs and symptoms in this population, but really, importantly, what's going on from an endoscopic perspective.
Can I answer the question.
You will see in CD-001 both clinical response from a CDAI perspective and clinical remission so you can compare that to what you saw on a slightly different patient population in the IGON-2 study.
The relative correlation between what you see in the mucosal signs and real healing, it's been an area of major debate, particularly in Crohn's disease.
Much clearer, you can see in Crohn's disease it's been an area of major debate.
There's a couple of recent review articles looking at all the data that are out there that sort of provide a picture.
But, the only correlation that's arisen that I'm aware of that you can see is, if you get control from a signs and symptoms perspective early, and you start to see some improvements in the mucosa, it generally leads to a positive effect when you get out to week 52.
So, that's basically what we're looking for in new Crohn's treatment ---+ signs and symptoms, significant remissions, and signs that it's actually starting to work at the early time points, and seeing endoscopic response, endoscopic improvements.
And those things together yield a probability of a patient being in long-term remission and getting through endoscopic healing at those longer time points.
Thanks for the question.
This is <UNK>.
We believe that our treatment of strategic collaboration transactions, where the portion of an upfront is related to the acquisition of rights, is excluded from non-GAAP is appropriate.
The acquisition of rights is unique to the formation of the collaboration, it's very strategic, and it's not part of our ongoing operations.
Of course, subsequently after that collaboration is formed, all other ongoing operating costs of the collaboration, whether they be development costs, they be milestones, they be royalties, co-commercialization, all the ongoing operational activities that we do together with our collaborator are included in our non-GAAP presentation.
I think that's the way we've always thought about it.
It's very hard to forecast strategic transactions.
It's something where I don't think many companies talk about what M&A deals they are going to do next year or what collaboration activity they're going to do.
And there are many reasons we could talk about in terms of how to think about this and how it makes sense.
In the interests of time now, since we're almost on the hour, I won't drag you through all that at this point.
But in the interest of time, our approach has been consistent for many years.
It's not uncommon across the industry.
Many companies have the same approach.
Importantly, we're fully transparent on all the factors we have in our GAAP to non-GAAP presentation, always have been.
And so anybody who wants to particularly look at it slightly differently certainly is able to do that.
That's fine.
At this point, really, we feel we're right on track with where we've been.
Obviously we are always talking to all the government agencies, the SEC and everybody else.
Some of those ongoing dialogues occur over lots of different topics.
Basically if something comes out of that, we'll communicate that.
But at this point really there's not much to talk about.
It's <UNK>.
We've got 12 other analysts who are trying to ask a question, so I'm going to ask that you go back into the queue.
And I think we're ready for the next caller
Yes, we are collecting those biomarkers and it should be part of either the oral presentation or a publication at some point in time.
But we are collecting them.
Thank you, <UNK>.
Where we are right now, we would always, similar to what we did with OTEZLA, we would always take a look and have some discussions and see what's in the environment.
There's been a lot of interest in ozanimod and MS and a lot of companies and others have reached out to us.
The way that I would look at this is you would like to see the fullness of the program and the Phase 3 data before finalizing any decision on how you're going to commercialize in any of the commercial aspects including pricing or partnering or other things.
We're going to get that data and we should have a good view on that in the first half of next year.
But we feel confident if we make the decision to go ahead and go alone, we feel very confident that we can do that very successfully.
We're doing that right now currently with OTEZLA.
It's a very relatively tight specialty group of physicians.
It fits what we do at Celgene.
If we looked at the data and made an organizational decision to move forward alone, we feel very confident that we would be able to do that.
We would also look to talk to partners, as well, if that made sense in terms of the overall value of the asset and the reach to patients worldwide.
