Question-and-Answer Session
Operator
(Operator instructions) Your first question comes from the line of David Webber with Broadpoint Capital.
David Webber – Broadpoint Capital
Thank you. Couple questions, first just to clarify the projection of $20 million in royalties, is that from AVINZA alone or is that from AVINZA plus potential royalties from other products?
John Sharp
No. That is just AVINZA alone.
David Webber – Broadpoint Capital
Okay. Thank you. Regarding LGD-4665, John you mentioned that you had completed the food study with no particular signs of food effect, so does that mean that unlike PROMACTA, there presumably wouldn't be no need to take the capsules two hours before or after eating?
John Higgins
David, that is our expectation at this time. With these pharmacology studies, you're testing the limits of various end points. We really think there is few, if any, limitation with food, and in the protocol, the Phase II study design that we started does not have any express fasting or limitation on food consumption related to intake of the drug, which we are excited about. Clearly it's early in terms of evaluating the drug in sick patients, but if our early Phase I study is proven out in the clinical trials, we think that can be a very important way to differentiate our drug from the competitors.
David Webber – Broadpoint Capital
Okay. Can you tell us what the primary end point is in the Phase II ITP trial?
John Higgins
Yes. Sure. Really, we're looking at the increase in platelet counts. There are two ways it's measured. The patients will be enrolled with a baseline of less than 30,000 platelets per microliter of blood. So, that's the baseline enrollment. So, a patient will be scored a success if either they have a doubling of their baseline platelet score or if their ending platelet count after six weeks of treatment is greater than 50,000 platelets per microliter of blood.
David Webber – Broadpoint Capital
Okay. Last question is, I was intrigued when Glaxo the other day disclosed their PDUFA date and their expectation (inaudible) by then. What is the latest thinking to your knowledge regarding the likelihood of an advisory committee review?
John Higgins
A good question. We don't know. We don't have any inside track at the GSK's dialogue with the FDA. So, it's just speculation. Obviously, in this category, we know Amgen had a panel meeting, and there's just no communication from GSK publicly about what their expectations are. So, the date that they announced a few weeks ago is essentially six months out from when they first submitted their NDA. So, there's no mystery in that date. But happens now between and then and whether they will have an advisory panel meeting, we do not know.
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