Question-and-Answer Session
Operator
(Operator instructions). And we will go first to Eric Schmidt of Cowen And Company.
Eric Schmidt - Cowen And Company
Good morning. Let me start with a question on M-Enoxaparin. Craig, are the discussions with the FDA solely focused on the amniogenicity filing or are they a little bit more wide ranging than that and if so, could you comment what else is being debated?
Craig Wheeler
Well, we don't comment specifically on the conversations with the agency as we're in communication with them quite frequently at ODD. But I would say the focus of the agency at this point and time is around right now making sure that they have the heparin inspection in China done.
Eric Schmidt - Cowen And Company
Okay and on that note, would all four suppliers need to pass inspection prior to approval or might you get away with, you know, fewer successful suppliers but just less product at the end?
Craig Wheeler
Yes, again, we can't predict the FDA's approval requirements but we do – I guess I could say confident that the inspections will be completed quickly and that they will not have any problems. But we don't know that for sure yet.
Eric Schmidt - Cowen And Company
So you wouldn't know if you could get approval with just one or two suppliers out of China?
Craig Wheeler
It really depends on the FDA and their view of the product. Remember this is an unapproved product at this point and time. So and they're working through plowing new ground in China with the inspection of these suppliers.
Eric Schmidt - Cowen And Company
Okay. Then turning over to your fellow on biologics programs. Any update on, you know, what your partnership thoughts are there and also when we may learn a little bit more about your internally developed candidates?
Ian Fier
Yes, so I think we're right at this point and time trying to be crisp about what we think our advantages in terms of building the technology. We're looking at different partnership options including timing of those partnerships and we'll make those decisions I think as legislation get involved and some of the players get clarified and where we can be at with our technology to maximize value for the shareholders.
I do not expect that you will see us talking about specific products soon. Because we are really trying to figure out what the pathway is and we want to make sure we retain any competitive advantage we have in terms of being able to choose the products as well as develop the products without attracting undue competition for what we are doing.
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