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Post by mnholdem on Apr 21, 2015 17:11:58 GMT -5
Another consideration is that validation / certification / approval requires the lines to run for a specified period of time. Provided that no adverse quality issues came up, MannKind has been building up inventory of the 12-unit cartridges, minimizing the delay to when they can be made available without supply shortage concerns. Sooner than many suspect, we may be pleasantly surprised to learn that Sanofi also has a production facility ready for operations to produce Afrezza in preparation for EU/Japan launches. Things may get interesting in a hurry around here.
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Post by jpg on Apr 21, 2015 17:39:41 GMT -5
Gomnkd? Is that you or did someone steal your alias? You are joking right? That is unrealistic (and I am holding back here big time). I am starting to question your thought process on some of these comments. For markets analysis you can get away with a lot because who knows how markets behave. Prices and valuation are short term unpredictable. For the science part of it you have to be careful so as not to overstep. I will consider this 'idea' a simple lapse in kinetics judgment from a non scientist financial analyst and nothing more (or someone stole your ID). If you want I am certain many of us who understand the science and needed logistics for what you are suggesting will explain how disconnected what you are suggesting sounds. Is this jpg or someone hijacked your id? I thought I am dealing with a professional and courteous person, not one who is condescending and rude. I don't know what is it with some people who are presented with an idea or thought that they cant agree with and just go nuts (my views on valuation, shorting etc). 1) I've a Masters in Engineering, I've background in electrical, electronics, little bit of applied mechanics, fluid mechanics, thermodynamics etc. That is 6 years of college (4 for Bachelors+2 yrs Masters). Do not assume someone's background just based on a few posts. I don't assume that you are just a pill pusher. 2) Have you seen/touched Afrezza inhaler? All it has is a little cartridge with powder and 5 cent plastic inhaler. This is not rocket science. I do understand it involves getting the powder of right shape, size, and getting flow right. 3) Do me a favor? Google Metered dose inhaler and read some material. Come back with some refutations. I am ignorant about medicine, but I learn all the time. I talk to lots of doctors and know how to do DD. This is my last post interacting with you. Gomnkd, This is simple. Do you think Mannkind has the partner, money time and desire to completely go through the whole process of building another inhaler and whole new delivery system? How much? 1 billion$? 500 million$? What if it doesn't work? Will it scare off other partners who will 'wait for the 'next generation' before partnering? Do yu even remotely think the discussion you started does anything of value for our (mine at least) company? Does this line of argumentation not simply devalue an important millstone: 12 units cartridge? Sorry if you find me rude but for someone who prides himself on financial analysis and financial rectitude that is one strange idea. And yes I was upset that yesterday during what seems to have been a bear raid you, a historically credible and knowledgable poster, added oil to the fire. And yes I find this latest idea of variable doing unrealistic and poorly timed doubt as to the value of the current delivery system we have. There will not be another one so pointless second guessing of the value of what we have serves what purpose? This may be your last post interacting with me that is certainly your choice but I will certainly point out pointless FUD when I see it.
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Post by dallasfan on Apr 21, 2015 18:32:53 GMT -5
Instead of all these cartridges, they should come up with a new inhaler that has a reservoir, dial, mouth piece. The dial will have Units scale and upon setting, it'll move set amount from reservoir to staging area in mouthpiece. The inhalation will empty storage area's insulin. Patient can dial to any amount they need (0.5U to 20U) and inhale. I thought about that too but that then adds manufacturing complexity and cost. The brilliance of Afrezza is the very inexpensive dreamboat device that can be manipulated with just one hand. Doing what you want would really upset the one handed diabetics out there and we wouldn't want that, would we? Besides, I tend to think that a 2U isn't needed only because internally, MNKD has done the research and found there wouldn't be enough of a demand to justify the cost and that 4U is just the right minimal amount to cover what most diabetics need. The 2U will definately be needed. A lot of the early users want to dial it in. Plus...afrezza for children are on the horizon.
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Post by notamnkdmillionaire on Apr 21, 2015 19:07:07 GMT -5
I thought about that too but that then adds manufacturing complexity and cost. The brilliance of Afrezza is the very inexpensive dreamboat device that can be manipulated with just one hand. Doing what you want would really upset the one handed diabetics out there and we wouldn't want that, would we? Besides, I tend to think that a 2U isn't needed only because internally, MNKD has done the research and found there wouldn't be enough of a demand to justify the cost and that 4U is just the right minimal amount to cover what most diabetics need. The 2U will definately be needed. A lot of the early users want to dial it in. Plus...afrezza for children are on the horizon. FOr kids sure but I don't think you'll see a 2U until Afrezza has a solid and profitable market established. We'll see.
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Post by mnholdem on Apr 21, 2015 20:35:14 GMT -5
Al mentioned smaller unit cartridges in connection to the pediatric trial in his recent interview, stating those sizes wouldn't be available for quite some time. As I recall, the timeline for that trial is five years.
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Post by tripoley on Apr 22, 2015 6:35:28 GMT -5
Insurance will be more than happy paying for one 12 unit cartridge rather than one 4 + one 8 unit cartridge. Retail 8u (30) + 4u (60) = $250 plus a 8u (60) + 4u (30) = $275 is $525 total. 12u (90) will retail as ? $375 maybe?
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Post by dreamboatcruise on Apr 22, 2015 11:41:28 GMT -5
This is really good news for the Type 2 market. Hopefully manufacturing Lines 2 and 3 are soon approved and much improved sales follow fairly quickly. I certainly hope so. It is and there are 1.1M T2s on basal that need insulin intensification: Attachment DeletedThe targets in both segments are defined as people with A1c above 7.0, which is CURRENT recommendation from ADA. The Endo professional organization recommends 6.5, and most believe that even 6.5 is doing harm... just that trying to push below 6.5 raises risks of hypo... before Afrezza that is. I wonder how much of that dark blue would be converted into target patients if the threshold were 6.5? What if it were 6.0? I'd think a conservative guess would be at LEAST another 1.5m patients if 6.0 and very likely 2m. Insurers will be reluctant to pay for it initially with patients under 7.0... but when lots of patients start driving A1c below 6.0 with low risk of hypo, the ADA will almost certainly lower their target and then insurers will fall in line.
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Post by mnholdem on Apr 22, 2015 12:38:11 GMT -5
Alethea,
I'm pretty sure that the FDA needed to approve the manufacturing method (lines 2 & 3) before they could give final approval for the 12-unit Afrezza cartridge. That would mean that the lines have been approved and are running.
Unlike a milestone payment, MannKind may not see CMC certification of additional lines as a reportable material event and therefore may not file an SEC report within the 4 days after the event as is typically required by the SEC.
Also, since responsibility for regulatory now belongs to Sanofi per the Agreement, it is Sanofi's responsibility to file any required SEC documents related to the FDA's approval of the 12-unit cartridge.
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Post by traderdennis on Apr 22, 2015 14:09:13 GMT -5
The targets in both segments are defined as people with A1c above 7.0, which is CURRENT recommendation from ADA. The Endo professional organization recommends 6.5, and most believe that even 6.5 is doing harm... just that trying to push below 6.5 raises risks of hypo... before Afrezza that is. I wonder how much of that dark blue would be converted into target patients if the threshold were 6.5? What if it were 6.0? I'd think a conservative guess would be at LEAST another 1.5m patients if 6.0 and very likely 2m. Insurers will be reluctant to pay for it initially with patients under 7.0... but when lots of patients start driving A1c below 6.0 with low risk of hypo, the ADA will almost certainly lower their target and then insurers will fall in line. Agreed, the equation is savings in (reduced hypos + savings in reduced long term complications from hyperglycemia ) must be a magnitude greater than the cost of afrezza treatment + potential lung issues - savings in 2nd line treatment drugs ) Once the right half of the equation in the eyes of insurance becomes true, Afrezza will be a front line med in the eyes of insurance. I think this will take 5-10 years for acceptance by insurance companies.
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Post by afrizzle on Apr 22, 2015 15:14:40 GMT -5
Very interesting discussion...
I've missed something though. Is the 12u approved and released?
I'm seeing part numbers and dosing instructions but no press release.
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Post by bradleysbest on Apr 22, 2015 15:25:56 GMT -5
FDA just approved the 12U cartridge. Not sure if they are producing it yet.....
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