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Post by mnholdem on Jul 17, 2018 8:26:31 GMT -5
Why? Does this thread have too much Foreplay for you?  |
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Post by mnholdem on Jul 16, 2018 11:18:37 GMT -5
We're way off the beaten path on the subject of this particular 8K filing. I'm locking this thread. |
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Post by mnholdem on Jul 16, 2018 8:52:21 GMT -5
Perhaps folks are looking at this the wrong way in wondering when the ADA will "replace" RAA insulin with Afrezza.
Frankly, I think that it's more likely that the ADA will create a new class of insulin: ultra rapid-acting. Like all the drugs on the ADA Standard of Care, I would see this new class as an alternative to current RAA rather than a replacement. However, scientific understanding is rapidly progressing and evidence continues to mount that a faster insulin that simulates normal pancreatic function has significant health benefits.
That evidence may lead to placing new ultra-rapid acting insulin up the ladder as a 2nd treatment, particularly with treatment immediately following early diagnosis of Type 2 diabetes. However, it doesn't take much research to reach the conclusion that sufficient clinical evidence exists, about how controlling TIR has significant short- and long-term health benefits, to satisfy the ADA's criteria for integrity and quality of data.
Therefore, if the ADA does create a new classification, ultra rapid-acting insulin may find a place in the Standard of Care for both Type 1 and Type 2 diabetes that would benefit sales of MannKind's Afrezza and quite possibly Novo's Fiasp (under pressure from BP).
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Post by mnholdem on Jul 16, 2018 8:24:44 GMT -5
I had to scroll a few pages to find it:
July 16, 2018
The 2018 MM&M Awards: The Shortlist
...
TV Advertising Campaign
• Allergan, Ironwood, and FCB Health for Linzess Wearing on you (Campaign) with Burdened and Overwhelmed (executions)
• Bayer Animal Health and ghg | greyhealth group for Advantage II Big Flea
• MannKind and Precisioneffect for Afrezza MannKind, Afrezza
• Pfizer and FCB Health for Eucrisa Almost Everybody, Almost Everywhere
• Pfizer and HealthWork Pfizer-Dreams
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Post by mnholdem on Jul 13, 2018 8:58:35 GMT -5
I just want Deerfield to go away. As soon as we can pay off the total debt to them the better. The shorting they do around payment of their debt with stock is killing us. I know Mike C. has said that he appreciates them working with us. But this is getting tiring. They just sell every share they get and short it before each announcement. You know the saying: “With friends like Deerfield, who needs ......” That will be huge when it finally happens since nearly 100% of MannKind’s assets (including intellectual property) is held as collateral to Deerfield. |
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Post by mnholdem on Jul 12, 2018 11:37:24 GMT -5
If you go to 1:23:22 of the presentation (link above) Castagna and Kendall stated that publication "will be in mid-July". It was the first question of the Q&A following their presentation. They did not state a specific date, though. |
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Post by mnholdem on Jul 12, 2018 8:57:54 GMT -5
David Kendall MD, Chief Medical Officer for MannKind Corporation, recently made a remarkable statement - which he reaffirmed at a recent investor's conference - that even though there have been 60+ clinical trials and nearly 3 dozen pre-clinical trials that evaluate Afrezza over the past 20 years, involving over 5,000 patients, MannKind has released 10 medical publications related to only 6 trials.
Kendall referred to the unpublished data as "Veins of Gold" and it sounds like he is planning to release many publications in the coming months and years.
Currently, 4 poster presentations have been accepted for the European Association for the Study of Diabetes 2018 Meeting in Berlin Oct 1-5, 2018. One of those presentations, highlighted in the graphic below, is totally new. Dr. Kendall will be producing evidence that diabetes, itself, has a more detrimental effect on pulmonary function than does Inhaled Technosphere® Insulin.
David talked a bit about this data at the 46-minute mark of his recent presentation. Link: lifesci.rampard.com/20180627/player.html
It hasn't escaped my attention that David Kendall's name is listed among the authors for those presentations whose studies were completed years ago and for which results were never published. For example, a few months ago, Kendall mentioned that MannKind was in possession of volumes of CT-SCAN data which, IMO, will likely form the basis of the first listed EASD2018 presentation on pulmonary function.
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So, it appears that MannKind's new CMO and his team have been busy digging through years of clinical data from multiple Afrezza trials and are, indeed, unearthing veins of gold which will be extracted, refined and then presented to the medical community. I suspect that the EASD Pulmonary Function presentation will be only one of many future publications as David Kendall's team continues to dig through and analyze the Afrezza trial data.
As a long time investor, I'm looking forward to seeing what else the new CMO digs up.
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Post by mnholdem on Jul 10, 2018 17:52:40 GMT -5
Of course. Try to drive pps down so that your fund managers can load up on the stock at a bargain. |
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Post by mnholdem on Jul 10, 2018 12:25:47 GMT -5
MannKind Co. (MNKD) Shares Bought by Schwab Charles Investment Management Inc.
Posted by Darrell McKinsey on Jul 10th, 2018
Excerpt:
Schwab Charles Investment Management Inc. raised its stake in MannKind Co. (NASDAQ:MNKD) by 31.7% in the first quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission. The institutional investor owned 248,110 shares of the biopharmaceutical company’s stock after buying an additional 59,682 shares during the period. Schwab Charles Investment Management Inc. owned approximately 0.19% of MannKind worth $566,000 at the end of the most recent reporting period.
Other institutional investors also recently modified their holdings of the company. Geode Capital Management LLC increased its holdings in MannKind by 14.7% in the fourth quarter. Geode Capital Management LLC now owns 551,568 shares of the biopharmaceutical company’s stock valued at $1,279,000 after buying an additional 70,542 shares in the last quarter. Zeke Capital Advisors LLC purchased a new position in MannKind in the fourth quarter valued at about $306,000. Wells Fargo & Company MN increased its holdings in MannKind by 63.3% in the fourth quarter. Wells Fargo & Company MN now owns 146,916 shares of the biopharmaceutical company’s stock valued at $340,000 after buying an additional 56,965 shares in the last quarter. BlackRock Inc. increased its holdings in MannKind by 82.8% in the fourth quarter. BlackRock Inc. now owns 3,534,811 shares of the biopharmaceutical company’s stock valued at $8,201,000 after buying an additional 1,600,802 shares in the last quarter. Finally, Raymond James & Associates increased its holdings in MannKind by 54.6% in the fourth quarter. Raymond James & Associates now owns 156,554 shares of the biopharmaceutical company’s stock valued at $363,000 after buying an additional 55,266 shares in the last quarter. 19.42% of the stock is owned by institutional investors.
Source: www.fairfieldcurrent.com/2018/07/10/mannkind-co-mnkd-shares-bought-by-schwab-charles-investment-management-inc.html
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Post by mnholdem on Jul 10, 2018 12:08:33 GMT -5
Q&A: New developments with inhalable medicines
By Tim Sandle 20 hours ago in [July 9, 2018] in Health.
Excerpts:
Digital Journal caught up with Castagna to discuss his company’s novel treatments.
Digital Journal: What is the extent of diabetes in the developed world?
Michael Castagna: Unfortunately, diabetes is increasing in the developed world. According to the CDC, 30.3 million U.S. adults have diabetes, and 1 in 4 are unaware that they have it. Diabetes is the seventh leading cause of death in the U.S., and is the No. 1 cause of kidney failure, lower-limb amputations and adult-onset blindness. Over the last two decades, the number of adults diabetes with diabetes has more than tripled.
DJ: Why did you decide to develop an easier to administer form of diabetes treatment?
Castagna: Al Mann’s vision was to make the treatment of diabetes easier for patients. He assembled the technology to improve upon currently available insulin delivery options. Afrezza offers patients a method of delivering insulin for mealtime glucose control that is not injected, and due to the way insulin is distributed through the lungs, it has an unmatched time action profile for both how quickly the insulin can work and how long a dose of insulin may stay in the system.
DJ: What has been the response from the medical community?
Castagna: The reaction has been very positive from many medical professionals. We’re extremely excited as more and more of those in the medical community are realizing the advancement we’ve made with inhalable insulin.
For others, like any new innovation (consider those who took a while to move from the flip phone to the iPhone), it can take some time to adopt the very latest. We find that most of the time, once medical professionals learn about Afrezza and start providing it to patients, they continue to prescribe it.
Also, we continue to work to educate doctors and help them understand that the benefits of this product go beyond inhalation; and that the greatest benefits revolve around the rapid-acting nature of our inhaled insulin at mealtime.
Read more: www.digitaljournal.com/life/health/q-a-new-developments-with-inhalable-medicines/article/526679#ixzz5Ks8kvslR
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Post by mnholdem on Jul 10, 2018 10:21:20 GMT -5
This is another very good meta-analysis study report from 2014 that I quote quite often:
onlinelibrary.wiley.com/doi/full/10.1002/dmrr.2603
Excerpt:
Building on results of this trial and those of six other smaller trials of STII [Short-Term Intensive Insulin] therapy, a meta‐analysis involving 839 participants (including 251 patients randomized to STII therapy in the above study 44) was performed and further underscored the robustness of the evidence supporting STII therapy 50. In that analysis, 46% of patients remained in drug‐free remission after 12 months. All but one study showed an improvement in beta‐cell function, as assessed by homeostatic model assessment [HOMA]‐B, and all but one study showed a decrease in insulin resistance, as assessed by HOMA‐IR.
In the pooled data, the proportion of patients in drug‐free remission was:
- 66.2% [292/441] at 3 months
- 58.9% [222/377] at 6 months
- 46.3% [229/495] at 12 months
- 42.1% [53/126] at 24 months
These rates of remission are far greater than those that can be achieved with any other currently available medical therapy for diabetes.
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Current guidelines and STII therapy
Despite these promising results, the use of insulin as a first‐line therapy in newly diagnosed patients with type 2 diabetes remains underutilized as an effective treatment option. One reason for this lack of acceptance is that current treatment guidelines for type 2 diabetes do not adequately address the concept of STII therapy and are generally cautious in their recommendations about when to initiate insulin.
For example, the American Diabetes Association [ADA]/European Association for the Study of Diabetes [EASD] guidelines emphasize progressive intensification of treatment and recommend metformin as the preferred initial therapy for most patients, reserving insulin as a later‐stage therapy or as an option for people with HbA1c ≥10–12% 8. In the latter group, the ADA/EASD guidelines do mention that it may be possible to taper off insulin once initial glucotoxicity is reversed and to transfer to other types of antihyperglycaemic medications.
In the American Association of Clinical Endocrinologists 2013 algorithm, insulin is recommended for patients with symptoms and HbA1c ≥9.0% 7.
In the International Diabetes Federation Global Guidelines, insulin is listed as a third‐line or fourth‐line therapy 54.
Chinese guidelines also list insulin as a third‐line treatment 55.
None of these guidelines mention STII therapy, despite a growing body of evidence supporting its use. The Global Partnership for Effective Diabetes Management model recommendations do mention temporary use of insulin for newly diagnosed adults with HbA1c >9% [75 mmol/mol] but do not elaborate further nor strongly endorse the STII therapy concept 56.
On the basis of the evidence in the literature and our own clinical experience, we propose that expert panels and diabetes organizations involved in developing and promoting treatment guidelines and algorithms for type 2 diabetes should discuss STII therapy more formally in future revisions and consider listing this therapy as an option for newly diagnosed patients.
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Post by mnholdem on Jul 7, 2018 17:09:45 GMT -5
Logical strategy since it's much easier to get better terms on financing if a company is demonstrating sales growth vs shopping around in desperation.
I agree the mgt is also following up their ADA presentation, striking while the iron is still hot. But this must remain a sustained effort in order to build greater awareness and interest.
I'm looking forward to reading new publications. I think doctors want to know more. Well, fans, Kendall has left the on-deck circle and stepping up to the plate.
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Post by mnholdem on Jul 5, 2018 18:45:09 GMT -5
It's absolutely true that here at ProBoards-MNKD we are somewhat of a "tempest in a teapot". We've yet to see the diabetes community buzzing about the newest insulin to hit the market. More than anything else, that was a monumental failure by the previous management team. They thought Afrezza would fly off the shelves.
As a longtime MNKD investor it seemed to me that this company was always starting over. I don't think that is the case anymore. Mike, David, Pat and the rest of today's management team are moving MannKind in the direction it needs to go in order to build greater awareness among doctor and patient alike.
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Post by mnholdem on Jul 3, 2018 14:49:54 GMT -5
IMO how trial data gets presented to the medical community can be more important than the raw data itself. CMO David Kendall stated at the recent investors conference that the first publication of data presented at ADA2018 will happen within the next two weeks.
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Post by mnholdem on Jul 3, 2018 14:29:57 GMT -5
You'll notice that mgt has added the Total Units for each package. The previous mgt forgot that little detail, forcing doctors and pharmacists to have to find a calculator to figure out monthly prescriptions.
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