Question-and-Answer Session
Operator
(Operator Instructions) First question is from Richard Smith with JP Morgan. Please go ahead with your question.
Richard Smith - JP Morgan
Yes, good morning and congratulations on the progress so far. Just quick question on JAK2 myelofibrosis, can you just give us a sense of how much the patient data you think you will need have when you go to the FDA with respect to the number of patients also length of treatment and any sense sort of the kind of endpoints that they might suggest you to use in a pivotal trial? Thanks.
Paul Friedman
As I may have mentioned this last time, but we've had several meetings with experts in the field and the consensus has been that endpoints either sustained and profound reductions in spleen size, which we've pretty much across the board with or without the quality of life improvements, where we've dramatic and remarkable changes are thought to be very, very important improvements in the status of these patients by our experts.
So, we're coping and I'd say optimistic that when we meet with the FDA that they will agree with that general premise. The devil is always in the details and I think we already have enough patient data to safely go to them and begin to discuss in detail how we would do a registration trial.
Richard Smith - JP Morgan
Do you think that you might have just mentioned this reduction in splenomegaly as part of a sort of competent endpoint or do you think that's sufficient on its own?
Paul Friedman
I'll answer this and then if haven't completely answered Rich can either correct me or add to what I'm saying. I think it could well be the primary endpoint and quality of life could be secondary endpoint or that could be co-primary endpoints. What do you say Rich.
Rich Levy
Yeah. I mean, we don't -- we're pretty comfortable that what even if what we think we're going to hear from FDA is not exactly right that any changes that they may make would be something they were equally comfortable with doing. So, if it's purely spleen that's fine, if it's spleen plus other things that should be fine too. We don't by any means expect to get into anything like a survival endpoint for initial approval.
There is plenty of precedent for drugs that are having even just improvements on sell counts and nothing has reduced spleens, nothing has reduced symptoms like this drug is doing. And we believe that the FDA is likely to appreciate that and we should have more to be able to tell you after we meet with them.
- To read the full transcript on Seeking Alpha, click here »
