Question-and-Answer Session
Operator
(Operator Instructions) Your first question comes from the line of Marshall Urist with Morgan Stanley. Please proceed.
Marshall Urist - Morgan Stanley
Yeah, hi guys, good morning. Couple of things, first one just from your comments on the – on the Pfizer, Pfizer said in their call; so, is it safe to assume from that then that discussions around kind of what the filing package needs to look like, there has obviously been some concerns about additional – potential additional studies et cetera that that – that that’s been cleared away?
Armando Anido
Yeah, we have not initiated nor has Pfizer initiated any additional studies and all along we’ve been saying that we believe the package we’re submitting to the BLA was actually going to sufficient for EMEA. So, I think that they are planning on submitting in early ‘10 at this point.
Marshall Urist - Morgan Stanley
Okay, great. And then relative to your comments on sort of how finishing up the FDA review is going, can you give us any kind of sense of sort of what the kind of rate limiting steps or sort of outstanding issues are at this point – coming out of the panel?
Armando Anido
Yes, Marshall, we don’t actually comment on specific steps along the pathway relative to regular – regulatory interactions. We feel really good about where we are at this particular point and we’re working diligently with the FDA in order to get this thing across the line. I wish I had better sense on the exact timing, but I can’t give you anything else at this point.
Marshall Urist - Morgan Stanley
Okay, great. Thanks. I will get back in the queue.
Armando Anido
Great. Thanks.
Operator
Your next question comes from the line of Salveen Kochnover with Collins Stewart. Please proceed.
Salveen Kochnover - Collins Stewart, LLC
Good morning, thanks for taking my questions. On the payer front can you walk us through in detail where you stand on XIAFLEX pricing discussions and your strategy to aid physicians with reimbursement?
Armando Anido
Yes, let me start with kind of the pricing conversation at this point. The price will be set sometime after we have received approval and we will disclose that publicly once the final price has been put in place. We have done an extensive amount of market research talking to payers, physicians as well as patients in order to really kind of get a sense for what would be the optimal price that we can charge for XIAFLEX. And at some point post the approval that would be when we actually disclose the price. Roger may be able to add a little bit more color on some of the coding and reimbursement.
- To read the full transcript on Seeking Alpha, click here »
