Question-and-Answer Session
Operator
Thank you. (Operator Instructions) And we'll go ahead and take our first question from Bret Holley with Oppenheimer.
Bret Holley - Oppenheimer
I have a question on the biosimilar side, how are you preparing in an environment where we don’t really know what their requirements for clinical trials will be for biosimilars? How are you preparing to that requirement without getting into specifics of the program? How are you thinking about that?
Craig Wheeler
That’s a very good question, and I think we like others are kind of feel our way in terms of what exactly will be required, but we do anticipate that clinical trials will be required for these. But we also are gone in the principal that the better understanding of the molecule that you have, the more you'll be able to better define those trials on the specific issue you need to look at in them. So, as you would expect with the (inaudible) our first place is to fall back on our characterization, understanding of the molecules and processes, but then we are beginning to think through what types of trials might be necessary but of course the final regulations are needed to clarify that path for us.
Bret Holley - Oppenheimer
Obviously without a clear pathway, my guess is going to be on a program by program basis. Do you have advisors that you are giving I guess kind of when you might be shifting this towards those requirements?
Craig Wheeler
Well I would say that we are as deeply involved with any company in what's going on in the Hill and the FDA and legislation here. So, we are paying very close attention with many advisors on that front. I also agree with your premise that it will product specific. I think in any legislation that will come out will be product specific as these products are very different depending if they are chronic or acute use depending upon if they are antibodies or unglycosylated proteins, the possibility in this field.
Bret Holley - Oppenheimer
The final question I would have is more over 30,000 foot kind of new question is, I guess what now that we are in August, what gives you reasonable confidence that you could prove M-Enoxaparin 2009?
Craig Wheeler
We continue to say, we can't predict what the FDA will do here but our view in terms of the cooperation that we had with the FDA, the working, the ability to answer the questions and what's left to do in the runway, we feel we are in a position where it is certainly feasible to have approval this year. In other words we are not sitting behind a wall of work that says there no way we could actually finish this to be able to get approved. We feel pretty good about things, but it is really subject to the various parts of the agencies that are actually dealing with the application.
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