Post by mnkdnyc on Feb 19, 2014 8:33:54 GMT -5
Cowen cut target to 5.50 today and mnkd is presenting at the cowen conf. next week 2/25. Funny how this stuff works. Are they just trying to get in lower?? They only own 24K shares. Sounds like they missed the boat.
Here is the dialog from yesterdays call with cowen asking the questions:
Cowen & Company
In your discussions with FDA right now, are any of them related to the AdCom? And is there any way to help us narrow down what the focus of the AdCom may be other than saying efficacy and safety of the product?
Hakan Edstrom - President, Chief Operating Officer, Director
The discussion with FDA at this point is purely focused on submission. We will really not know where the FDA will be coming from in terms of their questions until the briefing document becomes available. So we do not know yet what the focus of the AdCom committee will be, and that’s why we have to prepare ourselves for a broad range of questions across both efficacy and safety of the product.
Simos Simeonidis - Cowen & Company
Given that in the past we have not expected to have an outcome, and now there is kind of a change in thinking at the FDA, can you help us understand, maybe from your interactions with them, and I know there’s been a change of leadership of that section of the FDA, how that came about? What are they communicating with you in terms of why now they wanted to do an AdCom, where in the past they had not requested one?
Chairman of the Board, Chief Executive Officer
First of all, as you noted, there was a change in leadership of the division that’s responsible in the bureau. But the second point is that we’re asking the FDA to approve a new class of product, and there’s an FDA guidance that requires that.
Simos Simeonidis - Cowen & Company
But that had been the case in the past, and we’ve heard you and the rest of the management team say that there’s no reason to expect one.
Alfred Mann - Chairman of the Board, Chief Executive Officer
Well, the prior leadership didn’t think she needed one, but I’m not sure there was any focus on the new class of product.
Simos Simeonidis - Cowen & Company
And then in terms of your thoughts about timing of European submissions, I guess we’ll wait for potential approval in the U.S. first, before we get there? Or is this something you may want to do with a partner?
Hakan Edstrom - President, Chief Operating Officer, Director
Certainly if this is appropriate, depending on the partner we end up with, certainly we would rely on them to do so. However, I would say that we ourselves, in preparation for submission to the European community, if need be, but that certainly would follow after U.S. approval, because our resources are really tapped out right now, in preparation for the FDA review and subsequent approval.
Cowen & Company
In terms of potential commercial effort that may be needed further in the U.S., can you give us an idea of what types of size of sales forces and marketing help you would need, the type of things that you’re talking with your partners about. And would you want to keep, for example, U.S. copromotion rights? Or would you want to just outlicence AFREZZA to the partner?
Hakan Edstrom - President, Chief Operating Officer, Director
If you look at, say, the size of the sales forces, I would say in general it’s to cover the entire market, [unintelligible] four through 10 and the endocrinologists. You’re probably looking, I would say, in the thousand range in terms of sales reps and regional support people and managed care. So that’s probably a guideline number. In regards to copromotion rights, at this point in time, where we stand, I prefer not to comment on that.
Here is the dialog from yesterdays call with cowen asking the questions:
Cowen & Company
In your discussions with FDA right now, are any of them related to the AdCom? And is there any way to help us narrow down what the focus of the AdCom may be other than saying efficacy and safety of the product?
Hakan Edstrom - President, Chief Operating Officer, Director
The discussion with FDA at this point is purely focused on submission. We will really not know where the FDA will be coming from in terms of their questions until the briefing document becomes available. So we do not know yet what the focus of the AdCom committee will be, and that’s why we have to prepare ourselves for a broad range of questions across both efficacy and safety of the product.
Simos Simeonidis - Cowen & Company
Given that in the past we have not expected to have an outcome, and now there is kind of a change in thinking at the FDA, can you help us understand, maybe from your interactions with them, and I know there’s been a change of leadership of that section of the FDA, how that came about? What are they communicating with you in terms of why now they wanted to do an AdCom, where in the past they had not requested one?
Chairman of the Board, Chief Executive Officer
First of all, as you noted, there was a change in leadership of the division that’s responsible in the bureau. But the second point is that we’re asking the FDA to approve a new class of product, and there’s an FDA guidance that requires that.
Simos Simeonidis - Cowen & Company
But that had been the case in the past, and we’ve heard you and the rest of the management team say that there’s no reason to expect one.
Alfred Mann - Chairman of the Board, Chief Executive Officer
Well, the prior leadership didn’t think she needed one, but I’m not sure there was any focus on the new class of product.
Simos Simeonidis - Cowen & Company
And then in terms of your thoughts about timing of European submissions, I guess we’ll wait for potential approval in the U.S. first, before we get there? Or is this something you may want to do with a partner?
Hakan Edstrom - President, Chief Operating Officer, Director
Certainly if this is appropriate, depending on the partner we end up with, certainly we would rely on them to do so. However, I would say that we ourselves, in preparation for submission to the European community, if need be, but that certainly would follow after U.S. approval, because our resources are really tapped out right now, in preparation for the FDA review and subsequent approval.
Cowen & Company
In terms of potential commercial effort that may be needed further in the U.S., can you give us an idea of what types of size of sales forces and marketing help you would need, the type of things that you’re talking with your partners about. And would you want to keep, for example, U.S. copromotion rights? Or would you want to just outlicence AFREZZA to the partner?
Hakan Edstrom - President, Chief Operating Officer, Director
If you look at, say, the size of the sales forces, I would say in general it’s to cover the entire market, [unintelligible] four through 10 and the endocrinologists. You’re probably looking, I would say, in the thousand range in terms of sales reps and regional support people and managed care. So that’s probably a guideline number. In regards to copromotion rights, at this point in time, where we stand, I prefer not to comment on that.
