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Post by peppy on Nov 29, 2024 19:50:38 GMT -5
Thanks,BT, that's the menu listing I couldn't locate and it matches the info presented on ST. That looks rather definitive to me. One more irresponsibly-managed, missed opportunity for Mike C on behalf of MNKD shareholders. This time, there's nothing to hide behind. It’s a Cipla approval, not Mannkind. Not mikes decision to put out a PR ryster505 , thank you for pointing this out. Manufacturer Name : Cipla Limited Manufacturing Site Address : Amphastar France Pharmaceuticals Sas, Usine Saint-Charles , Eragny Sur Epte France France-60590 Mankind Corporation, One Casper Street , Danbury Connecticut United States-06810 (chug chug)
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Post by peppy on Nov 21, 2024 13:26:52 GMT -5
Type 1 is the target population. I am sad to hear Stevil that they do not like Afrezza. The Continuous glucose monitors of the initial group, I remember them. The Glycemic control. Thank you Stevil for report.
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Post by peppy on Nov 18, 2024 19:19:11 GMT -5
PRC and Peppy: Agreed 100% that US healthcare needs a shakeup so that outcomes are the reimbursement multiplier rather than episodes of service. I'm not sure that RFKJr is the one I feel most comfortable to do it, but they are not asking my opinion. The basic issue with the cost of delivery in the US is the burden of administrative costs and the expectation of profit (notwithstanding the moral and ethical problems) because a heart attack victim cannot shop around, so there is not the truly competitive marketplace required in free market capitalism. Marketing costs also drive up the cost of care and drugs. Professional sports on television are bombarded with direct-to-consumer pharmaceutical ads. We using the drugs are paying for those. One comment that needs to be clarified for the record concerns Canada. Canada spends less than half (about 42%) for health care and covers all of its citizens, achieving better outcomes in infant mortality, preventable illnesses, and life expectancy. It should not be described as having socialized medicine, however (any more than Medicare and Medicaid are socialized in the US). Canada rather has a single-payer healthcare insurance system, which works like private insurance in the US but is funded by the federal and provincial governments. The providers work for chartered hospitals or are in private practices and clinics that the government does NOT operate. When I lived there, in each province, a resident was given a provincial care card that functioned like a Blue Cross/Blue shield card in the US. Regardless of the provincial issuer, that card was good throughout the country. Their national publicly funded system is called Medicare, and no co-pays or out-of-pocket expenses apply for essential (versus elective) healthcare services. For elective services, Canadians can opt for private insurance to help cover any costs and co-pays for elective care and pharmaceuticals. When the system was first developed at a conference in Saskatoon, Saskatchewan in 1957, there was considerable public opposition to the idea. Now, like Medicare and Social Security in the USA, Canadians would fight like hell if anyone suggested taking it away (despite the exaggerated tales of long waits and dissatisfaction promulgated in the US- primarily by the health insurance industry). I have a couple things to say of no use. 1st, "When the system was first developed at a conference in Saskatoon, Saskatchewan in 1957, there was considerable public opposition to the idea.." My understanding regarding the Affordable Care Act; when Mitt Romney was the 70th governor of Massachusetts from 2003 to 2007, "The Massachusetts health care reform, commonly referred to as Romneycare,[1] was a healthcare reform law passed in 2006 and signed into law by Governor Mitt Romney with the aim of providing health insurance to nearly all of the residents of the Commonwealth of Massachusetts. The law mandated that nearly every resident of Massachusetts obtain a minimum level of insurance coverage, provided free and subsidized health care insurance for residents earning less than 150% and 300%, respectively, of the federal poverty level (FPL)[2] and mandated employers with more than 10 full-time employees provide healthcare insurance." So dido. 2nd. A new hospital was built around the metro area here. I moved close to the new hospital. You should see some of the new homes here. Someone somewhere is making money. . .
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Post by peppy on Nov 17, 2024 9:27:10 GMT -5
Per NASDAQ (Nov. 8, 2024): Analyst Price Targets Based on the following firms: CANTOR FITZGERALD H C WAINWRIGHT LEERINK OPPENHEIMER HLD WEDBUSH SECURITIES CONSENSUS $9.5 Based on analysts offering 12 month price targets for MNKD in the last 3 months. The average price target is $9.5 with a high estimate of $12 and a low estimate of $7. In addition: RBC raised its price target from $5 to $7 (finally) Rodman & Renshaw have raised their price target today on MNKD from $8 to $10 Refinitiv/Verus downgrades Mannkind from HOLD to SELL. INVESTARS ANALYST ACTIONS - PUBLIC No On November 11, 2024 Refinitiv/Verus downgraded Mannkind (MNKD) from HOLD to SELL. Tudor Pickering Holt Downgrades MannKind to Hold From Buy, Adjusts Price Target to $5.50 From $7 MT NEWSWIRES Nov-14-2024 12:56 p.m. ET I am going with last weeks recommendation. $9.5 consensus and $12 on the outside. .
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Post by peppy on Nov 13, 2024 13:00:30 GMT -5
Just wanted to double check, LQDA is dead in the water until at least summer 2025 or is there a chance for that decision to be overruled? LQDA daily chart. schrts.co/eSnqDbipMNKD daily chart schrts.co/mQPPGcQn
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Post by peppy on Nov 12, 2024 19:07:35 GMT -5
My compliant is with health insurance, The insurer gets to pick which brand of insulin it covers being that they are considered non-inferior. Then the insurer gets a kick back for meeting sales targets. Called a rebate.
Words, between the lines of age. Tricky, tricky.
when I file that compliant it ends up in the circular file.
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Post by peppy on Nov 12, 2024 14:47:11 GMT -5
I wish the commercial could straight out say, Afrezza enters the blood stream quickly, peaks at 35 mins and out of the system in 90 mins. Perhaps a commercial with insulin and outsulin. I could not find one picture of insulin and outsulin. x.com/TheHarryx1/status/1766135262663356763/photo/1
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Post by peppy on Nov 12, 2024 13:31:11 GMT -5
RFK's comments are hard to understand because they're so broad (which is a little scary - I'm ok with change but not upheaval). My thought in answer to the question which started this thread is that the FDA is widely recognized as being less effective than its regulatory counterparts in other countries and an administration that sought a better balance could be good. A weird statistic I remember from my youth (and told to me by a nurse working on her RN, BSN) was that the US had a higher infant mortality rate than some 3rd world countries. US medical treatment isn't always the best in the world. I've known people who were going to or did actually travel to unusual places to get treatments that were unavailable in the US because of the FDA. (I've heard the same from people in countries like Canada too, but not sure whether that's a regulatory issue or a socialized medicine issue or both.) United States: 5.4 deaths per 1,000 live births in 2021, ranking 33rd out of 38 OECD countries January 31, 2023 US Has Highest Infant, Maternal Mortality Rates Despite the Most Health Care Spending www.ajmc.com/view/us-has-highest-infant-maternal-mortality-rates-despite-the-most-health-care-spending#US maternal mortality in 2020 was over 3 times the rate in most of the other high-income countries, with almost 24 (23.8) maternal deaths for every 100,000 live births.
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Post by peppy on Nov 11, 2024 14:28:37 GMT -5
The way Robert Kennedy Jr / FDA could help MNKD is allow Afrezza sold as regular insulin with device to be sold as regular insulin. Regular insulin is sold over the counter. The problem is the money. Who is willing to pay? Afrezza is expensive. I hear you and I do not discount what you are saying. I may have it wrong, as I think in some ways Afrezza is a volume business. The more volume sold the less the cost of sales. I think that is why Brazil and India have been targeted. Here in the US, I can imagine, some people trying 4 units, type two's or type 1's that use it on a high spike. I say 4 unit because it is so safe. 35 mins peak, 90 mins out. Maybe 30mg/dl.
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Post by peppy on Nov 11, 2024 13:33:45 GMT -5
The way Robert Kennedy Jr / FDA could help MNKD is allow Afrezza sold as regular insulin with device to be sold as regular insulin. Regular insulin is sold over the counter.
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Post by peppy on Nov 10, 2024 13:25:39 GMT -5
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Post by peppy on Nov 8, 2024 12:29:09 GMT -5
I did not see Mike C or the new financial officer mention the convertible bonds. Did I miss it? finance.yahoo.com/news/mannkind-mnkd-q3-2024-earnings-041518224.html"Loss on extinguishment of debt of $7.1 million for the nine months ended September 30, 2024 was incurred in connection with the prepayment of the MidCap credit facility and the Mann Group convertible note in April 2024. Cash, cash equivalents and investments as of September 30, 2024 were $268.4 million."
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Post by peppy on Nov 8, 2024 11:08:09 GMT -5
Ofev (nintedanib) revenues $3.8 billion ....... if we can build a better mouse trap. FDA-approved Drugs for IPF Currently, two drugs are FDA-approved for treatment of idiopathic pulmonary fibrosis (IPF), which is the most common form of PF. These include nintedanib (Ofev®) and pirfenidone (Esbriet®). These medications are called anti-fibrotic agents, meaning that they have shown in clinical trials to slow down the rate of fibrosis or scarring in the lungs. These drugs are approved for patients with mild, moderate and severe IPF. OFEV® (nintedanib capsules), for oral use Gastrointestinal disorders: Diarrhea, nausea, and vomiting have occurred with OFEV. Treat patients at first signs with adequate hydration and antidiarrheal medicine (e.g., loperamide) or anti-emetics. Discontinue OFEV if severe diarrhea, nausea, or vomiting persists despite symptomatic treatment. (5.3) Gastrointestinal perforation has been reported. Use OFEV with caution when treating patients with recent abdominal surgery, previous history of diverticular disease or receiving concomitant corticosteroids or NSAIDs. Discontinue OFEV in patients who develop gastrointestinal perforation. Only use OFEV in patients with known risk of gastrointestinal perforation if the anticipated benefit outweighs the potential risk. (5.7) content.boehringer-ingelheim.com/DAM/b5d67da8-329b-4fa4-a732-af1e011fc0a5/ofev-us-pi.pdfFrom the earnings CC; We saw no dose-limiting toxicities or dose implications on FEV1. And we also saw in our chronic tox study, no significant signals or adverse event findings that would prevent us from moving forward in a chronic administration of this product. So we're really happy to wrap these two things up. We will meet with the FDA on our proposal for further development to move this into a Phase 2/3, hopefully here in 2025. That is good. The liver..... "WARNINGS AND PRECAUTIONS------------------------ Hepatic impairment: OFEV is not recommended for use in patients with moderate or severe hepatic impairment. In patients with mild hepatic impairment (Child Pugh A), the recommended dosage is 100 mg twice daily approximately 12 hours apart taken with food. Consider treatment interruption, or discontinuation for management of adverse reactions in these patients. (2.3, 2.4, 5.1, 8.6, 12.3) Elevated liver enzymes and drug-induced liver injury: ALT, AST, and bilirubin elevations have occurred with OFEV, including cases of drug- induced liver injury. In the postmarketing period, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcome, have been reported." ------------------------------------------------------------------ "The perforations; Gastrointestinal perforation has been reported. Use OFEV with caution when treating patients with recent abdominal surgery, previous history of diverticular disease or receiving concomitant corticosteroids or NSAIDs. Discontinue OFEV in patients who develop gastrointestinal perforation. Only use OFEV in patients with known risk of gastrointestinal perforation if the anticipated benefit outweighs the potential risk. (5.7)" If the perforations can be avoided, bingo. Have you ever seen someone with a perforated gut? Hours to live. the bacteria in the blood stream, Septicemia.
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Post by peppy on Nov 8, 2024 10:44:13 GMT -5
I found it interesting that there was a significant reduction in their sales force (40%). Was that a strategic decision or did they get rid of underperformers? It was unclear to me reading the transcript whether they are going to re-invest in new folks or stay with a smaller sales force. The sales team leader just paid himself 400,000; I thought perhaps he is the one out there trying to speak to physicians in their offices, never getting past the desk. Or perhaps he is ordering the staff lunch for the lunch time sales pitch.
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Post by peppy on Nov 7, 2024 21:20:15 GMT -5
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