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Post by peppy on Jan 6, 2024 8:24:22 GMT -5
Tell it to the FDA. Black box warning WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. ... The FDA relies on the drug companies to do the work, the EMA goes out and collects the data from the EU national health systems proactively. So while the FDA says it cancer in the mouse model the EMA have done the research to discover that it doesn't cause cancer in humans. The mouse model (rats and mice) is seldom a close match for humans, but if you are going to test to destruction you cannot use people. After all they can cure Type 1 diabetes in mice... I read the package insert last night. With warnings that the demand is so high, every attempt to get this product to prescribers is being made. Demand is high. www.novo-pi.com/saxenda.pdfThe study outcomes. Effect of SAXENDA® on Body Weight in 56-week Trials For Study 1 and Study 2, the primary efficacy parameters were mean percent change in body weight and the percentages of patients achieving greater than or equal to 5% and 10% weight loss from baseline to week 56. For Study 3, the primary efficacy parameters were mean percent change in body weight from randomization to week 56, the percentage of patients not gaining more than 0.5% body weight from randomization (i.e., after run-in) to week 56, and the percentage of patients achieving greater than or equal to 5% weight loss from randomization to week 56. Because losing at least 5% of fasting body weight through lifestyle intervention during the 4- to 12-week run-in was a condition for their continued participation in the randomized treatment period, the results may not reflect those expected in the general population. So a 5 foot 1 inch weighing 175 pounds qualifies on BMI. 10% is 18 pounds in a year. So 5% 9 pounds. (1 gallon of water weighs 8 pounds) Like the Boeing 737-9 I do not think Manufactures will get through this unscathed. 14.1 Weight Management Trials in Adults with Overweight or Obesity ThesafetyandefficacyofSAXENDA®forchronicweightmanagement in conjunction with reduced caloric intake and increased physical activity were studied in three 56-week, randomized, double-blind, placebo-controlled trials. In all studies, SAXENDA® was titrated to 3 mg daily during a 4-week period. All patients received instruction for a reduced-calorie diet (approximately 500 kcal/day deficit) and physical activity counseling (recommended increase in physical activity of minimum 150 mins/week) that began with the first dose of study medication or placebo and continued throughout the trial. In the 56-week trials, approximately 10% of patients treated with SAXENDA® and 4% of patients treated with placebo discontinued treatment due to an adverse reaction [see Adverse Reactions (6.1)]. The majority of patients who discontinued SAXENDA® due to adverse reactions did so during the first few months of treatment. In the 160-week trial the proportions of patients who discontinued due to an adverse reaction was 13% and 6% for SAXENDA®- and placebo-treated patients, respectively. Effect of SAXENDA® on Body Weight in 56-week Trials .6.2 Post-Marketing Experience The following adverse reactions have been reported during post- approval use of liraglutide, the active ingredient of SAXENDA®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Neoplasms Medullary thyroid carcinoma Gastrointestinal Disorders Acute pancreatitis, hemorrhagic and necrotizing pancreatitis, sometimes resulting in death, ileus Metabolism and Nutrition Disorders Dehydration resulting from nausea, vomiting and diarrhea Renal and Urinary Disorders Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis General Disorders and Administration Site Conditions Allergic reactions: rash and pruritus Immune System Disorders Angioedema and anaphylactic reactions Hepatobiliary Disorders Hyperbilirubinemia, elevations of liver enzymes, cholestasis and hepatitis Skin and Subcutaneous Tissue Disorders Cutaneous amyloidosis |
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Post by peppy on Jan 5, 2024 19:51:08 GMT -5
Your welcome. Saxenda® (liraglutide)Ozempic® (semaglutide)
as long as the word ends in tide.  You look good.........That is not a thyroid tumor. Apparently not. The EMA could find no causal link, and since they see literally all the prescriptions and outcomes not to mention cancer cases in Europe, it seems like that one can be put to bed. Tell it to the FDA. Black box warning WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. Saxenda® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Saxenda® and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Saxenda®. And No, your bowels didn't stop working. You are not going to perforate. You need a laxative and a stool softener.  .https://www.novo-pi.com/saxenda.pdf |
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Post by peppy on Jan 5, 2024 19:29:00 GMT -5
All we need is an FDA approved drug that so many people want.... they call us and we take the order. Also, look how many years this has been in the works..... direct to consumer Telehealth. How about Saxenda DPI at $100 a box? I heard Oprah saying she was looking for a "maintenance solution". We could sell afrezza direct for $35 and up-end the diabetes market and Saxenda DPI direct for $100 up-ending the diet market. I bet our biggest problem would be server crashes from too many hitting the website. Jack Bogle was the most hated man by Wall St. I wonder if Mike would like to be the most hated man by Big Pharma and the diabetes industry? No discount on Saxenda. Full pop.  Significant demand for weight-management medicines has impacted the availability of Novo Nordisk obesity medications, including Saxenda®.We continue to produce and ship all available Saxenda®, but unfortunately, you may still have difficulty filling Saxenda® prescriptions for the remainder of 2023 and beyond. SAXENDA® is a glucagon like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in: Adult patients with an initial body mass index (BMI) of • 30 kg/m2 or greater (obese), or • 27 kg/m2 or greater (overweight) • The recommended dose of SAXENDA® is 3 mg daily (2.3). Initiate at 0.6 mg per day for one week. In weekly intervals, increase the dose until a dose of 3 mg is reached (2.3). www.novo-pi.com/saxenda.pdfIt is a daily dose. The real body made GPP-1 doesn't last long in the body. Saxenda doesn't have the week extender molecules. What makes you think IV is the appropriate route? Thyroid Cancer a concern at all? Nurse, Hello, your friendly neighborhood nurse practitioner here. How may I help you today? Fat Caller. Hello, I am as fat as a house and I would like to lose some weight. I hear Saxenda works and I would like to get me some. Nurse Ok, how fat are you? Fat Caller, I am so fat. I had to get a seat belt extender. Nurse, oh that is fat. I believe you qualify as BMI ≥30 kg/m2, or ≥27 kg/m2 with one or more weight-related comorbidities, What is your name and address? What is your payment method? $1,700 a month You can track the order with the tracking number it will be delivered to your door in 5 to 12 days unless you want to overnight it...... Your welcome. Saxenda® (liraglutide)Ozempic® (semaglutide)
as long as the word ends in tide. You look good.........That is not a thyroid tumor. . |
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Post by peppy on Jan 5, 2024 16:22:50 GMT -5
All we need is an FDA approved drug that so many people want.... they call us and we take the order. Also, look how many years this has been in the works..... direct to consumer Telehealth. |
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Post by peppy on Jan 5, 2024 16:01:43 GMT -5
MNKD sales force is always, "restructuring." Now with Lilly which is based out of Indianapolis using Telehealth, perhaps less reps are needed in Indiana. If more corporations are going to Telehealth in general...... All that needs to be done is nurse practitioners and physicians to double sign the order. ..... Cutting out the middle men. OK I’m not seeing that.. “October 03, 2023 - Telehealth visit volume dropped from 76.6 million visits in the second quarter of 2020 to 41.5 million visits in the fourth quarter of 2022, representing a 45.8 percent decline, according to a new report by market research firm Trilliant Health.Oct 3, 2023” We are actually doing less telehealth because now that Covid is over we can’t prescribe across state lines. Just the start? www.nbcchicago.com/news/business/money-report/eli-lillys-direct-drug-sales-may-not-upend-the-industry-alone-but-others-could-follow-suit/3318928/ www.axios.com/2024/01/04/eli-lilly-zepbound-home-delivery All Lilly needs is physicians in different states with multiple state certifications and some nurse practitioners one in each state.. The difference is DEMAND. The Ozempic like drugs have huge demand I hear. Have I mentioned ad nauseam LLY trading all time highs? |
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Post by peppy on Jan 5, 2024 15:53:15 GMT -5
I just came across this on LinkedIn, kind of interesting ..talking about a restructuring. She was one of the best reps… 12:31 5 Kyrsten Strong • 2nd + Follow ENTON ONE Territory Business Mana... 1d • G After nearly 3 years with Mannkind I am now #OpenToWork. Due to a restructure within the organization I, along with many other sales representatives, are now searching for new opportunities. While restructures are never ideal, I am also 6 months pregnant with our first child so this hits especially hard. I have over 5 years of pharmaceutical sales experience. While I have specialized in the diabetes space, I am open to opportunities in other disease states or med device. I am based in the Indianapolis area and have built great relationships with HCPs throughout the state of Indiana. I appreciate the amazing people I've had the chance to work with at Mankind and I am excited for my next adventure! Kyrsten is open to work I MNKD sales force is always, "restructuring." Now with Lilly which is based out of Indianapolis using Telehealth, perhaps less reps are needed in Indiana. If more corporations are going to Telehealth in general...... All that needs to be done is nurse practitioners and physicians to double sign the order. ..... Cutting out the middle men. |
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Post by peppy on Jan 5, 2024 15:27:10 GMT -5
Please Mike, don't show up at the JPM conference. You are going to kill what ever mnkd sp is currently. We're going to be in the 2's again with your clown show and your prospects years from now. "I always deliver" and "I'm thinking several years ahead ". mymann just so you know, a bit too far for my tastes. |
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Post by peppy on Jan 5, 2024 15:23:58 GMT -5
In this debate about insiders selling their MNKD shares, the biggest seller was Al Mann and his estate, where it appears they dumped all of their shares. wrote, Page 5 Show share BALANCE, JUNE 30, 2023 268,235k. 323,770k is the fully diluted value if all the debit is converted to shares(the ones with conversion options....ie senior notes and mann group). you can see that 362000 share were sold through the ATM this quarter. 13000 to Mann group to pay interest,3.2 million for stock options and RSU 266000 employee stock purchase plan, and 36000 for Issuance of common stock from market price stock purchase plan whatever that is. to total of 4 million dilution this quarter. |
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Post by peppy on Jan 5, 2024 12:54:36 GMT -5
If Mike sells the remaining 9% royalty for 1 billion, we'll have lots of cash to give handsome bonuses to the BOD and management. good point..... let the good times roll. |
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Post by peppy on Jan 5, 2024 8:32:12 GMT -5
These are excellent points and additional examples of non-traditional DTC marketing. Thought leadership is important and consumer demand can help improve prescription writing, but the national TV DTC, flying hamburger or not, is a lesson in leverage. The fulcrum isn’t the consumers, it’s the doctors. Love these marketing ideas and would be pleased to see some pilot work on it at MannKind, but it needs to be integrated with knowing when it will work, and when it will waste resources. My sense is we need to see prescriptions budge (“move the needle”) first, and then by all means, proceed on marketing the shiznits out of Afrezza. Last point on the direct sales is there is a great bit of business case work there where pricing is partly a function of costs of distribution. If you reduce the distribution hurdles, pricing can be more attractive. Very cool. LLY weekly chart. schrts.co/bxjXFpYE all time highs |
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Post by peppy on Jan 4, 2024 23:03:27 GMT -5
Download the ada standard of care app and search for inhaled. Section 9 is the section of the ada doc that mentions inhaled insulin. [ Bill thinks inhaled insulin being soc would mean it replaces everything else. Thats not what soc is saying. Recommendations 9.1 Treat most adults with type 1 diabetes with continuous subcutaneous insulin infusion or multiple daily doses of prandial (injected or inhaled) and basal insulin. A 9.2 For most adults with type 1 diabetes, insulin analogs (or inhaled insulin) are preferred over injectable human insulins to minimize hypoglycemia risk. A Is it not important that is says (or inhaled insulin)? Did it not take forever to get inhaled even mentioned? Jun 6, 2018 at 8:52am compared with U-100 glargine in patients with type 1 diabetes (19,20). Rapid-acting inhaled insulin used be- fore meals in patients with type 1 diabe- tes was shown to be noninferior when compared with aspart insulin for A1C low- ering, with less hypoglycemia observed with inhaled insulin therapy (21). How- ever, the mean reduction in A1C was greater with aspart (–0.21% vs. –0.40%, satisfying the noninferiority margin of 0.4%), and more patients in the insulin aspart group achieved A1C goals of #7.0% (53 mmol/mol) and #6.5% (48 mmol/mol). Because inhaled insulin car- tridges are only available in 4-, 8-, and 12-unit doses, limited dosing increments to fine-tune prandial insulin doses in type 1 diabetes are a potential limitation. mnkd.proboards.com/post/149627=================================================================================== OR, my words, The mean reduction in A1c was greater with aspart because there was more hypoglycemia. . . |
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Post by peppy on Jan 4, 2024 20:19:56 GMT -5
studies in individuals with type 1 diabetes suggest that inhaled insulin has pharmacokinetics similar to RAA (7). Studies comparing inhaled insulin with injectable insulin have demonstrated its faster onset and shorter duration compared with the RAA insulin lispro, as well as clinically meaningful A1C reductions and weight reductions compared with the RAA insulin aspart over 24 weeks (144–146). Use of inhaled insulin may result in a decline in lung function (reduced forced expiratory volume in 1 second [FEV1]). Inhaled insulin is contraindicated in individuals with chronic lung disease, such as asthma and chronic obstructive pulmonary disease, and is not recommended in individuals who smoke or who recently stopped smoking. All individuals require spirometry (FEV1) testing to identify potential lung disease prior to and after starting inhaled insulin therapy. AFREZZA absorption into the bloodstream in under 1 minute and lower blood glucose levels in as little as 12 minutes. Afrezza reaches its peak effect after 35-45 minutes, depending on the dose Afrezza stops lowering blood glucose after 1.5 to 3 hours, depending on the dose.* *For the 4-unit and 12-unit cartridges, respectively. afrezza.com/afrezza-fast-facts/fast-facts-rapid-acting-insulin/ =========================================================================== Fast-acting insulin (Humalog) starts working within 15 minutes after injection, peaks in about 1 to 2 hours after injection, and lasts between 2 to 4 hours after injection. |
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Post by peppy on Jan 4, 2024 20:02:38 GMT -5
let the goods time roll.
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Post by peppy on Jan 4, 2024 19:56:49 GMT -5
This more of a rhetorical question really. Why would ANY company executive sink money into a stock that they may believe is being manipulated to the point where the executives believe that the share price is being suppressed? Wouldn't a smart executive wait until they were sure that any manipulation had ceased? Or the cost of living in CA is the highest in the USA. Home, vehicle, lawyers, divorce, homeowner insurance increase, Christmas and the water heater just went out. Rhetorical answer really. Out of Lunch money. |
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Post by peppy on Jan 4, 2024 4:44:10 GMT -5
Didn't like the flying hamburger commercial. Did like the attempt to "move the needle" on sales with Direct To Consumer (DTC) advertising. It was a fail, but didn't cost anymore than V-Go, so it was worth it to learn it wouldn't work.
Even after a successful Pediatric trial proving superiority (and SAFETY, SAFETY, SAFETY!!!), I'm not sure DTC is going to be important for marketing directly to the pediatric T1s. Maybe to get some general awareness, and in any case, just like last time, they need to see some measurable benefit from DTC to continue it.
I understand why Mike released the TV Ad - pressure from shareholders but as the CCO he should have known it was a horrible ad. Also he should have known the DATA was horrible on Afrezza and that doctors would not prescribe it. The vast majority of doctors rely on DATA and STUDIES and MNKD did not have the GOOD DATA. People see things differently, it was a fine television ad. Have you seen other pharmaceutical ads?They are all the same. Seemingly happy people taking a pharmaceutical that will kill them as the warnings play. They are in parks, they are shopping, blah, blah, blah, just happy to be living there best lives with clearer skin, or they can live with AIDS, or they are dancing because their blood glucose is now being peed out their urethra. MNKD studies are fine, non-inferior...the stuff is insulin. An inhaled insulin, that works faster and is out of the system quicker is non-inferior, yep. Have you seen the study set ups? The same set up for afrezza as subq. They work on different time frames. The data was fine. Turns out some of the old adages are not true to my way of thinking. The adage Aged tries to sell is Doctors rely on DATA and STUDIES. It is false. Physicians run offices that need employees. Physicians rely on health insurance for payment. Sneaky, sneaky, the insurance companies get to decide what insulin people take and turns out it is the one that pays the health insurer the largest rebate. The system the way it is set up, someone that doesn't know you or care about you is paid by an insurance company to make the best decision for you. The best decision is the product that pays the largest rebate to the insurer. Flying hamburgers seem Apropo. Rah, rah-ah-ah-ah Roma, roma-ma Gaga, ooh-la-la........ love me some flying hamburgers. Put some health insurance on that. |
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You look good.........That is not a thyroid tumor. 
