Question-and-Answer Session
Operator
Thank you. (Operator Instructions) We'll take our first question from Bret Holley with Oppenheimer.
Bret Holley - Oppenheimer
Yes hi. Thanks for taking my questions. I was just wondering, maybe you can't comment, but I'm just wondering if you could give kind of view of how the new FDA leadership may or may not expedite the decisions on generic Lovenox?
Craig Wheeler
Bret, thanks, this is Craig. I mean, obviously, we can't comment too much on the internal workings of the FDA because we just do predicting like anybody else out there would be. But our current sense is the application is moving forward and there doesn't seem to be any delays are being incurred because of uncertainty in leadership, our new leadership coming in. So we're... I guess I would say business is usual at this point.
Bret Holley - Oppenheimer
And regarding the Orange Book for follow-on biologics, I guess the question... I haven't seen any specific proposals for that and I'm wondering how the legal process might be complicated in the absence of such an Orange Book.
Craig Wheeler
Yes, 'm going to turn that over to our Chief Counsel here to comment on that.
Bruce Leicher
The proposals are actually to have a transparent like process which would necessarily used the Orange Book and they varied depending on the bills that are pending ranging from the Waxan bill (ph) to the Senate health bill.
But from our perspective we are fine whether its an Orange Book or not, as long as it's clear that one can go through the patent clearance process in advance at the time when it'd be eligible to launch.
Bret Holley - Oppenheimer
Okay. Thank you very much.
Craig Wheeler
Sure.
Operator
: (Operator Instructions). We'll take our next question from Eric Werner (ph) with Leerink Swann.
Unidentified Analyst
Hi, good morning guys. Thanks for update on your manufacturing facilities. I was wondering, can you kind of give us any insight of what was inclined (ph) from the Shanghai Number One warning letter to FSR... not exactly Lovenox.
Craig Wheeler
Yes. So obviously we can't comment on other people's applications. Warning letters are public in terms of what was happening with that manufacturer. We don't anticipate that that will have any direct part on our product.
As we said, our manufacturers in China have been inspected and we have no indication of any problems with those at this point in time. We are still awaiting final FDA documentation of that. But at this point of time we have nothing but positive results.
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