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Post by mannmade on Nov 10, 2016 16:05:22 GMT -5
I actually think the trick will be to develop the description of what "Sugar Surfing" is then use graphs and charts/pics as part of the dosing descriptions/instructions. Would make it very simple as follows:
Use AFREZZA in combination with a CGM (now that FDA has approved for dosing) to "Sugar Surf" as follows:
1. Check your cgm before you eat to establish your current blood sugar level 2. If under 150 do not take 3. Start your meal and check your blood sugar 10 minutes after you begin to eat, if your Blood Sugar is at 150 or higher then take a 4u cartridge of AFREZZA to start 4. Check your blood sugar every 10 minutes after you take your first 4u cartridge, and iuf your blood sugar continues to climb or only levels off but does not decline take another 4u cartridge after 20 minutes from taking the first 4 unit cartridge 5. Repeat the above until you have experimented enough with AFREZZA to understand your specific dosing needs.
Dosing needs will vary on the individual and the food/meals choices that are made as well as the quantity of foods but please note there is no need to count carbs as you can now manage your blood sugar with real time dosing and management of you blood sugar.
Now I am not a diabetic, nor do I profess to think it is this simple but on the other hand I thin with a few charts added to the instructions the concept can be conveyed in a much more straight forward way. Especially if accompanied by a link to a video that shows the same process.
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Post by mannmade on Nov 10, 2016 15:33:20 GMT -5
I don't think the scripts were being held down due to the cash situation. With that said, I don't know what's holding them down. Listening to Mike C. I got the sense the issue is much more complicated than we initially assumed. I'm hoping Mannkind takes advantage of the recent momentum and tries to sell off the drug. I still don't think they can do this on their own, though I would love to be proven wrong. I have to disagree. While I do not think it was/is the only reason I know for sure that it has played a significant part. I had lunch last week with one of my close doctor friends who as many know happens to be one of the top 5 prescribers in the country and was a KOL for Sanofi and is now doing same for MannKind. He told me several times over the last few months he had stopped prescribing AFREZZA until he could figure out if they would be around. When I had lunch with him last week he was re-energized and very excited and told me he had started to prescribe again based on what he was now seeing from 2.0.
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Post by mannmade on Nov 10, 2016 15:22:25 GMT -5
Yes so next quarter will not look so profitable and will show a big decline in revenue and MannKind operating at a loss again... It won't mean anything but expect the shorts to use it...
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Post by mannmade on Nov 10, 2016 15:20:23 GMT -5
Yes it may be, especially as benefits of pairing with cgm become more widely known and understood by insurance companies. I have said for quite a long time now that when combined with a cgm (which I think T2's should also have covered by ins) you will have a cure for diabetes without actually curing it and thus drive down much of the long term health care costs associated with the collateral deterioration of prolonged hyperglycemia.
Insurance companies are starting to look at long term benefits instead of just next quarters results. Witness the effort to drive doctors by rewarding them for achieving quality group metrics of success for patient populations. This is a long term effort and not a quarterly short term shift. Also as more hospital groups acquire sole practitioners and small practices and then include then in the treatment of a larger patient population this trend will only grow and technology (such as cgm's) will play an ever growing role and AFREZZAA becomes the perfect partner for this with diabetics. imho...
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Post by mannmade on Nov 10, 2016 15:12:23 GMT -5
Also likely with Dreamboat and cartridges you can "distill" and dispense different %'s of THC so depending on its use and the tolerance of the user/patient.
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Post by mannmade on Nov 10, 2016 15:09:59 GMT -5
I feel some sanity has now returned to the world as Adam F. has published his expected hit piece. Yes, I expected Fartstain to publish something to counter an excellent CC. Right on schedule. Must be Ground Hogs Day or something... Looks like he is coming out of hibernation... Perhaps a good storm will send him back... Whatever, he has lost all credibility as his so called path to BK never materialized...
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Post by mannmade on Nov 10, 2016 14:42:30 GMT -5
Agree with most everything. However, looking at the headwinds Afrezza has faced so far, I'd be skeptical that a label of ultra-fast would really make that much difference. If it isn't about lower A1c or lower incidence of hypos, I'd question whether it would really impact prescribing behavior. It's not as if the pk/pd profile isn't out there. If doctors are inclined to see benefit in quick action, they already have the data to understand Afrezza delivers. As for patients, unless MNKD is free to connect the dots and explain in ads that faster can mean better control and less hypos, merely being able to call it ultra-rapid may do little to ignite interest. If they get better labeling regarding the dosing, that could help set the stage for more consistently good patient experiences. I respectfully disagree as depending on the revised label guidelines, the use of "Ultra Rapid Acting" allows for the conversation of no stacking and therefore few if any hypos associated with a lower and healthier Hba1c. And believe me that will sell...
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Post by mannmade on Nov 10, 2016 11:50:35 GMT -5
Well patience has been rewarded and for all of the people who doubted they can now relax a bit and for the shorts they will just have to go back to their drawing boards and scheme up some new issues as money is no longer an issue until next July at the earliest...
My take away from yesterday was as follows:
1. Scripts will likely not improve anytime soon but steps are being taken to methodically work on understanding the issues and providing solutions and will likely help maintain a slow progression in a positive direction. I am not expecting a big jump anytime soon.
2. The balance sheet has been cleaned up big time and this should allow for a future less harsh form of financing should it become necessary.
3. There are still the possibilities of the "Positive Unknowns" between now and July 2017 as follows: a. RLS milestone and more clarity about future impact of relationship on MannKind b. International deal c. Epi deal d. New more experienced reps having a positive impact on sales and some slight expense offsets from their repping other manufacturers drugs e. Possible new partner such as Amphistar now that there seems to be a new relationship between MannKInd and Amphistar
But here is my BIG Takeaway: Am not sure if this was slip of the tongue by Ray but he said that they "expected approval for the label change by 4th Quarter of 2017," and that they were currently in on-going discussions with the FDA about it.
What Ray did not say was that they were expecting to get a decision by 4th Q 2017. So either he misspoke or he is very confident and sees this process as merely perfunctory.
So with the above said, it would seem that no matter where scripts go over the next 12 months, and I am assuming they will continue to climb methodically in relationship to the efforts being put forth... Once the label is changed to Ultra Rapid Acting and AFREZZA is in a class by itself, we will get liftoff... BIG Time! And therefore at a minimum all MannKind has to do for the next 12 months is stay in the game... But I am confident they will do more than simply stay in the game.
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Post by mannmade on Nov 10, 2016 11:36:46 GMT -5
But remember, AFREZZA was used at the Samsun trials for the AP and that has yet to be really made known. Once the AP is on the market and people who use it realize that you still need to bolus for meals, AFREZZA should get a boost.. Along with increased cgm market penetration. Think of AFREZZA as a digital or technological advancement in insulin because it is the only insulin able to react in real time which is what all of the new digital/technology pushes are driving in medicine right now.
I believe that pumps will get phased out and more diabetics will switch to a cgm plus basal (tresiba) and AFREZZA. Just as good if not better than an AP, less expensive, fewer moving parts, no batteries and less invasive to the body.
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Post by mannmade on Nov 10, 2016 8:29:07 GMT -5
You forgot to add back the Amphistar payments that are now being waived for 2017.
And as a kicker there is the $25m or so they will receive from the sale of their building.
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Post by mannmade on Nov 9, 2016 19:41:20 GMT -5
Well at least MannKind had a win today...
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Post by mannmade on Nov 9, 2016 19:40:10 GMT -5
MannKind Corporation MannKind and Sanofi Reach Agreement on AFREZZA(R) VALENCIA, Calif., Nov. 09, 2016 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) (TASE:MNKD) today announced that MannKind and Sanofi have entered into an agreement with the following terms: The promissory note and security agreement between MannKind and Aventisub LLC, a Sanofi affiliate, are terminated, with Aventisub agreeing to forgive the full outstanding loan balance of $71.56 million. MannKind is also relieved from its obligation to pay $0.5 million in previously uncharged costs related to the collaboration. Sanofi will purchase $10.2 million worth of insulin from MannKind in early December as part of its preexisting commitment to purchase insulin following termination of the collaboration and MannKind's exercise of a "put" option. The balance of the insulin "put" option ($30.6 million) is accelerated with Sanofi completing the cash payment of $30.6 million to MannKind by January 9, 2017. This payment will be made without MannKind being required to deliver any insulin to Sanofi. All issues arising out of the license and collaboration agreement, the supply agreement, the promissory note, the security agreement and the transition agreement are resolved. About MannKind Corporation MannKind Corporation (NASDAQ:MNKD) (TASE:MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. MannKind maintains a website at www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website. Company Contact: Rose Alinaya SVP, Finance
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Post by mannmade on Nov 9, 2016 17:30:06 GMT -5
They got the rights to China distribution I think. But all good by me!
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Post by mannmade on Nov 9, 2016 13:50:03 GMT -5
medicalxpress.com/news/2016-11-glucose-metabolism.htmlHome Diabetes November 9, 2016 Researchers discover new regulator in glucose metabolism November 9, 2016 Researchers discover new regulator in glucose metabolism Immunofluorescence microscopy of TSC22D4 (red) expressing cells. Credit: Helmholtz Zentrum München A key genetic switch in the liver regulates glucose metabolism and insulin action in other organs of the body. Researchers of Helmholtz Zentrum München, in collaboration with colleagues of the Heidelberg University Hospital, Technische Universität München and the Medical Faculty of the University of Leipzig, have now reported these findings in the journal Nature Communications. Diabetes mellitus is a chronic disease that has become increasingly prevalent in the population: More than six million people are affected by the disease alone in Germany. It is characterized by a disruption of the glucose metabolism and (except for type 1 diabetes) an impaired response of the body to the hormone insulin. Scientists are currently seeking to find the cause and possible regulators of the disease in order to intervene therapeutically. A team led by the metabolism expert Professor Stephan Herzig, director of the Institute for Diabetes and Cancer at Helmholtz Zentrum München (IDC), has discovered a new mechanism that is responsible for the regulation of the glucose metabolism. The transforming growth factor beta 1-stimulated clone 22 D4, abbreviated TSC22D4, acts as a molecular switch in the liver and from there regulates genes that can influence the metabolism throughout the body. Approach from Cancer Research "The current study is a successful continuation of our research activities with colleagues from the Internal Medicine at Heidelberg University Hospital," said study leader Herzig, who left Heidelberg in 2015 to become director of the Institute for Diabetes and Cancer at Helmholtz Zentrum München. Already in 2013 the researchers showed that increased production of TSC22D4 in the liver of mice with cancer leads to severe weight loss (cachexia) . In the present study, they investigated the role of this gene regulator in connection with diabetes. "The strong influence of TSC22D4 on the metabolism in tumor diseases suggested that it could also play a role in metabolic diseases," said first author Dr. Bilgen Ekim Üstünel of the IDC. In the current study, the researchers showed in diabetic mice that inactivation of TSC22D4 led to an improvement of the insulin action and glucose metabolism. Further analyses revealed that TSC22D4 in particular inhibits the production of the lipocalin13 protein, which is released as a messenger substance from the liver and can regulate the glucose metabolism in other organs. To check the relevance of the new mechanism in the clinic, the researchers examined liver tissue specimens of 66 patients with and without type 2 diabetes. They found that in the liver of the diabetes patients compared to people with normal glucose metabolism, the TSC22D4 gene was expressed significantly more often and lipocalin13 was produced correspondingly less often. "For the treatment of diabetes there is only a very limited number of therapeutic targets," said Herzig. "Next, we want to investigate whether our findings can lead to the development of a new therapeutic approach to treat diabetes and insulin resistance." Explore further: Smart drug clears fat from liver and blood More information: Bilgen Ekim Üstünel et al. Control of diabetic hyperglycaemia and insulin resistance through TSC22D4, Nature Communications (2016). DOI: 10.1038/ncomms13267
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Post by mannmade on Nov 9, 2016 10:30:21 GMT -5
To pay taxes?
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