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Post by u1682002 on Nov 11, 2016 15:38:04 GMT -5
Feel so much more relieved after the cc.
One question for this board is: is this typical to take 12m for a label change?
One additional question is: what is the chance to get a regional partner for China market before the label change? |
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Post by peppy on Nov 11, 2016 15:53:59 GMT -5
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Post by audiomr on Nov 11, 2016 16:09:20 GMT -5
I think China will be a difficult market, in multiple respects, and probably out of reach if we start slapping big tariffs on them.
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Post by saxcmann on Nov 11, 2016 16:14:55 GMT -5
Feel so much more relieved after the cc.
One question for this board is: is this typical to take 12m for a label change?
One additional question is: what is the chance to get a regional partner for China market before the label change? I thought it was 6 months? Good question. Maybe needed for label upgrade that really differentiates afrezza from other rapid acting insulins? |
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Post by mannmade on Nov 11, 2016 16:30:47 GMT -5
Yes it depends on the degree and level of change that is asked for as the supporting documentation becomes increasingly more detailed and expensive to produce (the studies)
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Post by peppy on Nov 11, 2016 17:25:28 GMT -5
I was listening to the conference call and came along the slide regarding the label change. 
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Post by letitride on Nov 11, 2016 22:25:41 GMT -5
I'm really hoping Trump will light a fire under the FDAs ass and get it done yesterday. The new policy should be if your new drug is good we invite you to a barbeque on the white house front lawn if not you are the barbeque.
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Post by derek2 on Nov 12, 2016 8:57:51 GMT -5
Feel so much more relieved after the cc.
One question for this board is: is this typical to take 12m for a label change?
One additional question is: what is the chance to get a regional partner for China market before the label change? I thought it was 6 months? Good question. Maybe needed for label upgrade that really differentiates afrezza from other rapid acting insulins? FDA standard is 10 months after submission; 6 months for priority review. This is not priority review. |
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Post by dunebuggy on Nov 18, 2016 2:11:21 GMT -5
Does anyone know when the label change was submitted? Imho this is the game changer...MNKD 3.0.
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Post by liane on Nov 18, 2016 6:27:40 GMT -5
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Post by matt on Nov 18, 2016 8:04:18 GMT -5
One additional question is: what is the chance to get a regional partner for China market before the label change? China and Japan, like most Asian countries, are based on relationships to a much greater extent than the US. You work to form the relationship first, then the business comes later. The relationship development process generally takes a year, or more, but then the business discussions can go rather quickly. The problem is that MNKD does not have somebody at a sufficiently high level that can make six to eight trips to the Far East in the coming months to get the relationship piece out of the way.
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Post by op2778 on Nov 18, 2016 8:10:42 GMT -5
Matt, you post good information and looks like you have a lot of knowledge, but you are too pessimistic. Let the guys works. If i remember well, you were talking a lot about BK (inevitable for you), but MNKD got 2 good deals. Yes, BK is not totally out of picture, but why be so pessimistic all the time?
That said, i enjoy reading your posts, but a little bit positive will not hurt....
Op
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Post by Deleted on Nov 18, 2016 10:32:02 GMT -5
I now suspect a Far East deal will show up
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Post by bradleysbest on Nov 18, 2016 10:38:24 GMT -5
Why? I know Japan was noted in the initial agreement with SNY that included a milestone payment. I wondered if discussions had already occurred with Japan before Al signed the licensing agreement.
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Post by comnkd on Nov 18, 2016 10:53:53 GMT -5
One additional question is: what is the chance to get a regional partner for China market before the label change? China and Japan, like most Asian countries, are based on relationships to a much greater extent than the US. You work to form the relationship first, then the business comes later. The relationship development process generally takes a year, or more, but then the business discussions can go rather quickly. The problem is that MNKD does not have somebody at a sufficiently high level that can make six to eight trips to the Far East in the coming months to get the relationship piece out of the way.
Why wouldn't MannKind host potential overseas partners in the U.S., give them tours of their facilities (maybe they're interested in a real estate deal in Valencia), meet with staff and the BOD, perhaps with endos and patients as well? Lead the horse to water and not carry the water to the horse... |
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