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Post by rrtzmd on Nov 30, 2015 10:58:54 GMT -5
12.2 Termination by the Parties. (a) Termination for Material Breach. In the event that either Party shall be in material breach in the performance of any of its obligations under this Agreement (the “Breaching Party”), in addition to any other right and remedy the other Party (the “Complaining Party”) may have, the Complaining Party may terminate this Agreement by giving notice in writing specifying the breach and its claim of right to terminate; provided, however, that if the breach is remediable, the Breaching Party shall have ninety (90) days (or forty-five (45) days for any payment breach) (the “Notice Period”) to rectify the breach and termination shall become effective at the end of the Notice Period only if the Breaching Party fails to cure the breach complained about during (i) the Notice Period or, (ii) if such breach (other than any payment breach) has not been cured within such 90-day period, if the Breaching Party has commenced actions to cure such breach within the Notice Period and thereafter uses reasonable efforts to cure such breach, such longer period as is reasonably required to cure such breach, but in any event, not to exceed ninety (90) days following expiration of the Notice Period; provided further, that, if Sanofi is the Breaching Party and the breach is with respect to Sanofi’s failure to comply with its obligation to use Commercially Reasonable Efforts with respect to (x) the United States, MannKind may terminate this Agreement in its entirety, and (y) any Major Market (other than the United States) or […***…] Country, MannKind may terminate this Agreement only with respect to such Major Market or […***…] Country (as applicable) and not in its entirety. If the Breaching Party disputes in good faith that it has materially breached one of... I'd say based on that provision of the contract, if MNKD feels that SNY hasn't lived up to what they expected with respect to Afrezza's marketing, they have an out. Granted nobody knows what was agreed to in reference to "Commercially Reasonable Efforts" and the big "x" is labeled as confidential, but from the basic look of it, MNKD could make the argument to terminate I believe. It would likely have to navigate the 90-day period for SNY to potentially address any perceived shortfalls. I'm no lawyer but on the verbiage alone, I think MNKD could make a good argument for termination. The problem is that MNKD agreed to work via the "joint committee" to resolve all disputes. Per the agreement, the final decision regarding any dispute is left to the Sanofi co-chairman of that committee, and you realize, of course, how he will vote. I doubt that there's much legal recourse given that agreement.
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8-K
Nov 29, 2015 21:43:35 GMT -5
Post by rrtzmd on Nov 29, 2015 21:43:35 GMT -5
There were execs who leaked Trade secret after leaving the company and signing NDA, non-competing agreement. They much less likely leak if still employed. On the other hand, keeping Hakan around allows him full access to any "trade secret" MNKD might possess or develop. Knowing for sure that he will be unemployed in a year and a half might provide Hakan motivation to utilize that access in his search for a new job or as a means of seeking other financial security.
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Post by rrtzmd on Nov 25, 2015 20:30:55 GMT -5
As I had said previously, before it mysteriously disappeared, I think Hakan was let go for fiddling while Rome burns. It does not surprise me that they would offer him a 2yrs salary + bonus severance package as this would be necessary if he was terminated in order to have an amicable parting of ways. The clever wording in the Press Release "Hakan will stay on staff" was likely arranged to justify paying $2-3mil(?) over the next two years while the company is already struggling with cash. What bothers me the most is the fact that future financing and subsequent shareholder dilution will include money to be paid to this very "silly" man who in my opinion did the company a great injustice in his many public (and private) blunders as CEO. It seems to me that MNKD should have announced simply that they felt it was time to find a new quarterback, and then bought Hakan out while giving him a plane ticket back to Sweden. As it is, investors are left with uncertainty while trying to figure out what, if any, role he is supposed to play through July of 2017. The image of him still being associated with MNKD can't be very encouraging to investors.
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Post by rrtzmd on Nov 25, 2015 20:19:06 GMT -5
But is that it? That link to Vaxserve's catalog has been there for several months now, I'm pretty sure. It doesn't even mention whether or how the devices relate to afrezza's spirometry requirements. I'm afraid I can't consider that much of a solution to the spirometry issue. Is there any information available about how many doctors have purchased spirometry equipment in order to meet afrezza's spirometry requirement? Is there any information about how many doctors have actually done spirometry themselves versus referring patients to pulmonologists?
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Post by rrtzmd on Nov 25, 2015 12:07:01 GMT -5
Looking through these, I noted that none of them mentioned the 12U dose. I haven't seen it mentioned anywhere else recently either. What happened to that?
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Post by rrtzmd on Nov 24, 2015 11:26:18 GMT -5
Unfortunately the information is somewhat dated at this point, since interviews will have been conducted last summer. Still, if someone has access it would be interesting to see what the Afrezza comments were. It's a serious list of KOLs. Thanks for posting. A review article from February of this year -- "Inhalation drug delivery devices: technology update": inhalation drug technologyA pretty thorough section about dry powder inhalers, but mentions neither dreamboat nor afrezza nor technosphere, and that is coming from the college of pharmacy at the University of Oklahoma, no less. Why don't these people know about MNKD's stuff?
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Post by rrtzmd on Nov 24, 2015 1:03:21 GMT -5
Not only is Alfred Mann a brilliant scientist, but he is also a wise investor. Alfred has put more than a $billion into Afrezza; if MannKind needs an additional $100 million to get through this transition period, do you believe he will not add an additional 10% to see a return on his initial investment? Where was Mr. Mann back in August? Why did MNKD have to resort to the almost embarrassing "back door" of cross listing in Israel in order to use TASE rules to force ETFs to buy MNKD stock? For that matter, where is Sanofi? Sanofi is supposed to be a partner, right? They're responsible for marketing the drug and have an economic interest in MNKD's survival and success, so why haven't they pitched in?
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Post by rrtzmd on Nov 23, 2015 11:26:14 GMT -5
Roughly, yes. I mentioned in a previous post up above how comparison is made difficult by afrezza being dosed in cartridges plus the reports of higher dosages being required to match the diabetic's previous dose of lispro as well as the sometimes required additional dose 1-2 hours after a meal in order to cope with late digesting carbs. One frustrating thing is that no one is reporting their actual cartridge usage -- i.e. keeping track of what they started with and how it is changing. Consequently, there's no way to estimate the average cartridge consumption, and that will be an important factor in how insurance companies make their decision. It looks like it depends on the insurance plan. The caremark cost estimator gives a very different picture for Afrezza under the federal NALC plans (one of the postal service employees plans) listed on opm's open season website: www.caremark.com/wps/myportal/FRAMED_CHECK_DRUG_COST [NOTE: This link doesn't work directly unless you have an account - requires log on. To get to the calculator you have to go through opm.gov/openseason, follow the plan information link and go to the NALC plan website, then follow a series of menus to the cost estimator (caremark) site: choose High Option Plan, Plans and Benefits, RX Drug Benefits, Prescription Cost Calculator. Likely the cookies needed to avoid log-ons are picked up along the way.] Try the different doses of Afrezza listed. And you can compare with other insulins as well. The coverage seems to be too good to be true. I almost have to believe there is an error in the calculator. The calculator shows an annual cost of $324.44 ($80 for each 90-day supply of 270 4-unit cartridges, using 60-cartridge packs). Note that the 60-cartridge packs are less expensive than the 30-cartridge packs. Afrezza is still more expensive than Novolog, but is very affordable. Maybe this is an error, but maybe insurance coverage is starting to significantly improve. Easier to reach via: NALC benefitsThen click on "prescription cost calculator" at the top of the page. The numbers they provide don't quite make sense. Afrezza annual cost for the employee: mail order = $324, retail pharmacy = $1253. But then it says employer's cost: mail order = $2384, retail pharmacy = $1532. Why the reversal? It seems like the retail should be higher either way. In any case, it points out the leverage large groups can have in getting improved benefits.
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Post by rrtzmd on Nov 22, 2015 11:13:19 GMT -5
Roughly, yes. I mentioned in a previous post up above how comparison is made difficult by afrezza being dosed in cartridges plus the reports of higher dosages being required to match the diabetic's previous dose of lispro as well as the sometimes required additional dose 1-2 hours after a meal in order to cope with late digesting carbs. One frustrating thing is that no one is reporting their actual cartridge usage -- i.e. keeping track of what they started with and how it is changing. Consequently, there's no way to estimate the average cartridge consumption, and that will be an important factor in how insurance companies make their decision.
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Post by rrtzmd on Nov 22, 2015 10:57:10 GMT -5
The other study was completed back in September and still has no results posted: 3-dose afrezza/lispro studySo I wouldn't look forward to the results to NCT02485327 being posted any time soon. Does MNKD have access to the results of the one completed in September?
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Post by rrtzmd on Nov 22, 2015 10:47:11 GMT -5
FYI - I work for a mail order pharmacy that does business with all 50 states and Puerto Rico/Virgin Islands. If any one would ever like to know numbers related to AWP, AAC, etc or copays or number of Rx's dispensed over specific time period versus another product, let me know. Some times I get bored at work and start doing random searches on products that interest me; that it is, when I am not day-dreaming about how awesome it would be if Afrezza had the numbers Lantus has had. Also, my gf who is also a pharmacist at a retail pharmacy, was just visited by a Afrezza drug rep! THEY DO EXIST!!! The question I would have should be straight forward? first- With no health insurance. Have a prescription for; (www.afrezzapro.com/dosing-configurations)
- Patients receive 60x4U + 30x8U combination boxes.
How much is the bill?
second- a type one diabetic. People diagnosed with type 1 diabetes usually start with two injections of insulin per day of two different types of insulin and generally progress to three or four injections per day of insulin of different types. The types of insulin used depend on their blood glucose levels. Studies have shown that three or four injections of insulin a day give the best blood glucose control and can prevent or delay the eye, kidney, and nerve damage caused by diabetes. - See more at: www.diabetes.org/living-with-diabetes/treatment-and-care/medication/insulin/insulin-routines.html#sthash.W6UtI9FV.dpuf ------------------------------------------------------------------------------------------------------------------ short acting I do not have much to go on here. I am not a type 1 diabetic. I may need help. What is the Bill for a vial of Apidra no insurance? What is the bill for Apidra •3 mL SoloStar prefilled pen? The total daily insulin requirement may vary and is usually between 0.5 to 1 Unit/kg/day. products.sanofi.us/apidra/apidra.html
I weight 170 pounds or 77 kg. so correct me when wrong... 34 to 77 units per day? (Look at the tails: screencast.com/t/pJPex48U Matt must be happy) Injection: 100 units/mL insulin glargine is available as: • 10 mL vials (3) • 3 mL SoloStar prefilled pen (3) APIDRA 100 units per mL (U-100) is available as: (products.sanofi.us/apidra/apidra.html) Open (In-Use) Vial: (Opened vials, whether or not refrigerated, must be used within 28 days. If refrigeration is not possible, the open vial in use can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 77°F (25°C). The opened (in-use) SoloStar should NOT be refrigerated but should be kept below 77°F (25°C) away from direct heat and light. The opened (in-use) SoloStar kept at room temperature must be discarded after 28 days.) APIDRA 100 units per mL •10 mL vials •3 mL SoloStar prefilled pen
-------------------------------------------------- Lantus - 100 Units/mL (www.lantus.com/hcp) 3 ml pens
Initiation of LANTUS Therapy Type 1 Diabetes: • In patients with type 1 diabetes, LANTUS must be used concomitantly with short-acting insulin.The recommended starting dose of LANTUS in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements.
NO insurance, what is the bill for Lantus 100 units/ml * 3 pens? ---------------------------------------------------------------------------------------------------------
This is a link to the Anthem "find covered drugs" page: provides estimates of annual costsIt not only tells you whether a drug is covered but also provides an estimate of the average annual cost for a specific dose. For the afrezza 4U/8U box that you describe, one each month costs $4,374.12 annually. One 100 cc vial of apidra per month would cost $1,406.28 annually. Five 3 cc apidra solostar pens per month costs $551 annually. For lantus, five 3 cc solostar pens costs $929.52 annually. Basic rules for dosing insulin: calculating insulin doseWith weight of 177 lbs, the estimate is 44U per day. Initially this is divided 50% slow/50% RAA, and then is adjusted according to patient response and usually tends towards an eventual 70/30 split.
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Post by rrtzmd on Nov 22, 2015 0:56:31 GMT -5
Probably best to try and compare cost per day. A Humalog quikpen contains 3 cc w each cc containing 100U of insulin, giving each pen 300U of insulin. Five pens -- 1500U -- cost $435 (per Goodrx). A typical type 1 rarely uses more than 2U per meal. Add on 2U required to prime the pen, and a type 1 would use -- typically -- 4U with each meal. Figure 3X a day, so 12U used per day. So 1500U provides 125 days of therapy. Cost per day is about $3.50. Comparison with afrezza is somewhat difficult since afrezza is dosed according to "cartridge." Afrezza requires one dose with a meal and may require an additional dose 1-2 hours after a meal, so figure 90 doses lasts at best 30 days, at worst 15 days. This does not take into account the increased dosing requirements with each meal compared to lispro that many users have been reporting. 90 doses of 4U cost about $300. So per day, the cost is between $10 and $20. Afrezza comes out costing 3-7 times as much as the humalog pen. And remember that does not include the higher dosing compared to lispro that many are reporting that afrezza needs. For a real world comparison, you can use Anthem's search engine: anthem estimatesAnthem does not cover afrezza, but still says costs $4,000 per year -- that's using 90 4U cartridges per month. Anthem also doesn't cover the humalog quikpen, but one quikpen used per month -- typical for most type 1s -- would cost $1,000 per year.
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Post by rrtzmd on Nov 20, 2015 11:34:57 GMT -5
I think it's premature to presume that Hakan was given a choice of resign or be fired. After all, Hakan has been there like 10-15 years already, so firing him now is a bit like calling the fire department after the house has burned down. Plus, as I understood it, he was Al'Mann's personal choice to be CEO back when he was originally hired and also when Al retired. Also, why fire him -- as opposed to finding a new CEO and then just replacing him? Then the news might have been perceived in a more positive light. As it is, with no explanation coming from the company, all investors see is that the ship has lost its captain. Al, while great, is still 90 years old and even though only "interim CEO," investors are bound to wonder if he is up to handling MNKD's current situation.
So I think one, at least, should reflect on the possibility that Hakan resigned because he either didn't like getting blamed and taking fire from critics -- perhaps for things over which he had no control over -- and/or, possibly,he didn't like what he saw looming on the horizon.
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Post by rrtzmd on Nov 19, 2015 23:35:47 GMT -5
While this study was not in people who had diabetes, Kalyani said the research is a reminder, especially to doctors who treat patients with diabetes and prediabetes, to keep in mind that some patients may respond differently to different foods. The researchers are currently enrolling volunteers in Israel for a longer-term follow-up dietary intervention study focused on people with consistently high blood sugar levels who are at risk of developing diabetes. www.cbsnews.com/news/huge-differences-even-when-people-ate-the-same-foods/---------- Maybe not MannKind related (?) but diabetes and Israel catch my attention these days. I do hope MannKind has an interest in Israel, especially for diabetes studies/trials/TS etc. The full study is here: full text of paperI'm already put off by a number of things. The title "Personalized Nutrition by Prediction of Glycemic Responses" makes me wonder if this isn't a setup for some company offering "personalized nutrition." I have seen the Weizmann Institute involved in a number of very shady dealings with some publicly traded stocks and the IPO hair on my neck are standing up. Most of the authors are immunologists and the overall slant of the article seems to be one of modifying the "microbiome" to find an individual's "optimum." The gut microbiome and probiotics have been a relatively frequent topic in the popular science press the past year since the FDA banned fecal microbiota transplants, and I'm a bit suspicious as to why so much effort was put into this particular paper. There are also technical issues -- e.g. using a $30 Bayer Contour to calibrate the CGMs, while not wrong, isn't reassuring. I haven't had time to study any further.
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Post by rrtzmd on Nov 18, 2015 22:14:41 GMT -5
EMA
Product-specific biosimilar guidelinesReference no. EMEA/CHMP/BMWP/32775/2005 Rev.1 Revision of the guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues. PDF documents: - Overview of comments
- Adopted guideline
- Second draft guideline
- First draft guideline
- Concept paper
www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp--- I dug up this EMA site today. Perhaps someone can read through these to report what the EMA actually considers in determining whether to classify an insulin application as a biosimilar. I have grandkids over tonight so I'll be very occupied for the evening. NOTE: ...as in occupying army. I posted yesterday: "There is really nothing mysterious that I can see. The October meeting lists one application for insulin under "Non-orphan generic and biosimilar medicinal products." Obviously, afrezza is not a generic. If you look at how the agency defines "biosimilar": defining biosimilar...and look under "Application of the biosimilar approach" on pages 4 and 5, it should be obvious that afrezza does not qualify. Although several of the details would likely disallow it, perhaps the most relevant is probably this one: "The posology and route of administration of the biosimilar must be the same as those of the reference medicinal product." While "route of administration" could make afrezza similar to exubera, posology -- referring to dosing -- is completely different than any other product -- at least I can think of no other drug that doses by blue and green cartridges. Hence, whatever insulin is being referred to as having an application under "generic and biosimilar" extremely unlikely to be afrezza." The link is to a pdf that gives a full description of how they view "biosimilar." As I pointed out, there are several things that would likely exclude afrezza from being biosimilar to anything. The most relevant one -- in my opinion -- was "posology," since afrezza is dosed in various colors of "cartridges."
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