Question-and-Answer Session
Operator
(Operator instructions) And your first question comes for the line of Joel Sendek of Lazard Capital Markets. Please proceed.
Joel Sendek – Lazard Capital Markets
Thanks. Good morning. My question has to do with your discussions with the FDA, we’ve heard someone on some other conference call this quarter that people are very skeptical about the FDA meeting their timelines and some are even thinking about not even asking for priority review. Did you get any sense that your pre-NDA filing or pre-NDA meeting that priority review might not be a valid strategy?
Mitchell Steiner
So the question is – thank you for the question Joel. This is Mitch. The question is the FDA has been missing a lot of its timelines and pushing them back and there may be sort of a sense that they may make a decision about priority review versus standard review based on what their work load looks like. And I think that from our standpoint we did not get any sense from the FDA one way or the other that their current workload was going to affect how they made a decision on whether we get priority review or not. What we did hear is that drugs that do not have anything – indications that do not have anything else indicated, in other words, there is no other drugs available for that indication, and that’s an unmet medical need, do quality for priority review, and they stuck to their guns on that. So I guess they are kind of being blind to the reality of whether they are going to meet that deadline versus whether or not we have the right to go down a certain regulatory pathway.
So the regulatory pathway is intact. In fact, I would argue, and this is Mitchell Steiner arguing now, that you have to think of our application more as a supplemental application in the sense that all – the NDA has been approved for Fareston 60 milligrams. And the sections that they would have to review are going to be peculiar to the clinical efficacy and the clinical safety and the CMC for this new line extension if you want to consider it that way. And so in some ways this may be – and this is Mitch talking now – this may be an easier evaluation for the FDA then starting from a new chemical entity.
- To read the full transcript on Seeking Alpha, click here »
