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Post by mnholdem on Feb 27, 2020 17:10:27 GMT -5
Can we please stay on topic??? Yeh, this thread has all the characteristics of a fret-less bass player...pretty much all over the place. |
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Post by mytakeonit on Feb 27, 2020 17:31:26 GMT -5
liane - If you read the posts ... I don't think they heard you.
But, that's mytakeonit
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Post by mango on Feb 27, 2020 23:05:47 GMT -5
Figglebird: Afrezza will never be the stronghold in Type 2. SGLT2i’s and GLP 1’s will rule. Read about Rybellsis the new oral GLP1. Mannkind can’t even get a stronghold with endos for type 1’s. GLP 1’s address the post prandial problem. GLP1’s only work when food hits the intestine (something a certain CEO didn’t know). Of course Afrezza is the greatest way to bring down your PPG, but not at $3000 a month for a type 2. Plus they couldn’t inhale that much inhalable insulin to begin with. If Mannkind doesn’t win the Type 1 war it’s over. And 4 yrs and 4billion dollars later they are not close. Glad to hear we’re still presenting and raising money. Oh..also kids aren’t going to inhale 6-8 times a day for correct coverage.
See full prescribing information for complete boxed warning.
• In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether RYBELSUS causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C- cell tumors has not been determined (5.1, 13.1).
• RYBELSUS is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors (4, 5.1).WARNINGS AND PRECAUTIONS• Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed (5.2). • Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored (5.3). • Hypoglycemia: When RYBELSUS is used with an insulin secretagogue or insulin, consider lowering the dose of the secretagogue or insulin to reduce the risk of hypoglycemia (5.4). • Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions (5.5). • Hypersensitivity Reactions: Discontinue RYBELSUS if suspected and promptly seek medical advice (5.6). ADVERSE REACTIONSThe most common adverse reactions, reported in ≥5% of patients treated with RYBELSUS are: nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation (6.1). WARNING: RISK OF THYROID C-CELL TUMORS
• In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether RYBELSUS causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions (5.1) and Nonclinical Toxicology (13.1)].
• RYBELSUS is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications (4)]. Counsel patients regarding the potential risk for MTC with the use of RYBELSUS and inform them of symptoms of thyroid tumors (e.g. 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 RYBELSUS [see Contraindications (4) and Warnings and Precautions (5.1)].Animal DataIn a combined fertility and embryofetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.2-, 0.7-, and 2.1-fold the MRHD) were administered to males for 4 weeks prior to and throughout mating and to females for 2 weeks prior to mating, and throughout organogenesis to Gestation Day 17. In parental animals, pharmacologically mediated reductions in body weight gain and food consumption were observed at all dose levels. In the offspring, reduced growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs) abnormalities were observed at the human exposure. In an embryofetal development study in pregnant rabbits, subcutaneous doses of 0.0010, 0.0025 or 0.0075 mg/kg/day (0.06-, 0.6-, and 4.4-fold the MRHD) were administered throughout organogenesis from Gestation Day 6 to 19. Pharmacologically mediated reductions in maternal body weight gain and food consumption were observed at all dose levels. Early pregnancy losses and increased incidences of minor visceral (kidney, liver) and skeletal (sternebra) fetal abnormalities were observed at ≥0.0025 mg/kg/day, at clinically relevant exposures. In an embryofetal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075, and 0.15 mg/kg twice weekly (1.9-, 9.9-, and 29-fold the MRHD) were administered throughout organogenesis, from Gestation Day 16 to 50. Pharmacologically mediated, marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with the occurrence of sporadic abnormalities (vertebra, sternebra, ribs) at ≥0.075 mg/kg twice weekly (>9X human exposure). In a pre- and postnatal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075, and 0.15 mg/kg twice weekly (1.3-, 6.4-, and 14-fold the MRHD) were administered from Gestation Day 16 to 140. Pharmacologically mediated marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with an increase in early pregnancy losses and led to delivery of slightly smaller offspring at ≥0.075 mg/kg twice weekly (>6X human exposure). Salcaprozate sodium (SNAC), an absorption enhancer in RYBELSUS, crosses the placenta and reaches fetal tissues in rats. In a pre- and postnatal development study in pregnant Sprague Dawley rats, SNAC was administered orally at 1,000 mg/kg/day (exposure levels were not measured) on Gestation Day 7 through lactation day 20. An increase in gestation length, an increase in the number of stillbirths and a decrease in pup viability were observed. Carcinogenesis, Mutagenesis, Impairment of FertilityIn a 2-year carcinogenicity study in CD-1 mice, subcutaneous doses of 0.3, 1 and 3 mg/kg/day [9-, 33- and 113- fold the maximum recommended human dose (MRHD) of RYBELSUS 14 mg, based on AUC] were administered to the males, and 0.1, 0.3 and 1 mg/kg/day (3-, 9-, and 33-fold MRHD) were administered to the females. A statistically significant increase in thyroid C-cell adenomas and a numerical increase in C-cell carcinomas were observed in males and females at all dose levels (>3X human exposure). In a 2-year carcinogenicity study in Sprague Dawley rats, subcutaneous doses of 0.0025, 0.01, 0.025 and 0.1 mg/kg/day were administered (below quantification, 0.8-, 1.8- and 11-fold the exposure at the MRHD). A statistically significant increase in thyroid C-cell adenomas was observed in males and females at all dose levels, and a statistically significant increase in thyroid C-cell carcinomas was observed in males at ≥0.01 mg/kg/day, at clinically relevant exposures. Human relevance of thyroid C-cell tumors in rats is unknown and could not be determined by clinical studies or nonclinical studies [see Boxed Warning and Warnings and Precautions (5.1)]. Semaglutide was not mutagenic or clastogenic in a standard battery of genotoxicity tests (bacterial mutagenicity (Ames), human lymphocyte chromosome aberration, rat bone marrow micronucleus). In a combined fertility and embryo-fetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.2-, 0.7- and 2.1-fold the MRHD) were administered to male and female rats. Males were dosed for 4 weeks prior to mating, and females were dosed for 2 weeks prior to mating and throughout organogenesis until Gestation Day 17. No effects were observed on male fertility. In females, an increase in estrus cycle length was observed at all dose levels, together with a small reduction in numbers of corpora lutea at ≥0.03 mg/kg/day. These effects were likely an adaptive response secondary to the pharmacological effect of semaglutide on food consumption and body weight. www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf ----------------------------------------------------- Thanks, but no thanks. |
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Post by kc on Feb 28, 2020 0:37:25 GMT -5
The reason why this product has never gain any traction it’s too costly for the type one and type two diabetics. insurance companies our unwilling to pay the high price for such a good product.
If the company is to survive the market the product it will have to be a total paradigm shift in the way that Afrezza is marketed.
While none of us know what the cost of goods to produce Afrezza might be. We know it’s priced very high equal to the best selling insulin drugs on the market.
If you want to get on a better schedule you need to cut the price 50% and hope that you don’t go out of business while you try to build a new base of users. show the pharmaceutical industry that you’re prepared to take it directly to the consumer with good pricing.
Formularies are chosen by the insurance companies based on prices and Afrezza it is priced too high.
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Post by Chris-C on Feb 28, 2020 0:39:08 GMT -5
Generally, IMO, it's a good thing to assume that when members post they deserve to be treated with respect and with an assumption that they can support the claims they make through verifiable means (facts, transcripts, published data, references, etc). However, if they make claims that cannot be substantiated or are shown to be misinformed and/or unfactual; and then they avoid responding to direct queries about their sources or access to such knowledge, then AFAIC, they should be politely ignored.
Having gone through the posts on the thread for the past 2-3 days, I'm surprised at the bobbing, head faking and unsupported assertions that were dominating the narrative for so long. Many people who know better and whom I respect greatly were somehow nearly tricked into believing that the poster knew more than they did because s/he was an employee or former employee. Such a perception, which was never validated, can fuel misinformation and stoke fear, uncertainty and doubt. As Abraham Lincoln is often quoted as saying "You can fool some of the people some of the time...but not all the people all the time." Call me one of the skeptics (or naive? skeptics) who happens to view those presumed "insider posts" as one person's largely refuted or unsupported opinions. Which begs the question of why they would bother to post with such conviction now if they had previously sold their holdings, as was reported?
Stay strong. Support efforts to raise awareness of Afrezza and the need for promoting retention through smart "VDEX-like" patient education and monitoring programs.
GLTAL
Chris C
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Post by kc on Feb 28, 2020 0:41:23 GMT -5
It’s all about pricing. The product cost too much.
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Post by rfogel on Feb 28, 2020 1:18:56 GMT -5
It’s all about pricing. The product cost too much. Indeed, the question is whether Mannkind can compete head to head with Lilly and Novo in dealing with insurers and PBMs. Right now Mannkind evidently lacks sufficient evidence to demand a higher price for its product. |
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Post by rockstarrick on Feb 28, 2020 2:48:14 GMT -5
It’s ok to disagree, and I am also deaf in my right ear, with the left being mediocre at best. I have been invited to publicly speak at several events, career days, even grade schools, I’m just basing my opinion on what I hear coming out of Mikes mouth, the speed, separation, enunciation, dynamics, and delivery. I am schooled in Public Speaking and have decades of experience being front and center in front of big crowds, and I just don’t think Mike is a good Speaker. I’m not anti Mike, but do wish he would slow down a little, and speak more clearly. I also understand that he has a lot to cover within a certain amount of time, he needs to prioritize the different topics and prepare his presentation a little better. You should be able to cover everything you intended to cover and have enough time to answer any questions without using the old “we’re out of time“ clause. trust me mango, talking is my strong point. ✌🏻😎 I can definitely understand that. Maybe we can get you to say a few words before your band plays at the Vegas Shareholder Party 🎸🎷🎺🥁 Your fricken ears will be bleeding, I had a public speaking class as a prerequisite for my Waterworks degrees, we’d have to give random 15 minute presentations. Classmates would show up stressed, nothing prepared, no worries, I got this, freestyle. Id talk for the whole period. You want me to take a class to learn how to talk!! they need one to teach me how to shut up. I love to bullshit. 😃 |
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Post by rockstarrick on Feb 28, 2020 2:58:06 GMT -5
It’s ok to disagree, and I am also deaf in my right ear, with the left being mediocre at best. I have been invited to publicly speak at several events, career days, even grade schools, I’m just basing my opinion on what I hear coming out of Mikes mouth, the speed, separation, enunciation, dynamics, and delivery. I am schooled in Public Speaking and have decades of experience being front and center in front of big crowds, and I just don’t think Mike is a good Speaker. I’m not anti Mike, but do wish he would slow down a little, and speak more clearly. I also understand that he has a lot to cover within a certain amount of time, he needs to prioritize the different topics and prepare his presentation a little better. You should be able to cover everything you intended to cover and have enough time to answer any questions without using the old “we’re out of time“ clause. trust me mango, talking is my strong point. ✌🏻😎 Deaf from the damn Marshall Stacks and singing poetic verse. I think the biggest set of stacks I ever witnessed was at the 1984 Van Halen Tour. Wish we had phones with cameras...shit, wish we had cellular phones...LOL I’ll bet that was a good one, actually I lost my right ear in a mini bike wreck back in grade school, and then the left was damaged by a bad bearing on a band saw In a meat shop I worked at. Most of the volume on stage is actually in front of the Band, the monitors we use keep us fairly shielded, sometimes a musician can get a little carried away with their stage volume, but usually it’s fairly quiet. ✌🏻🎸😎 |
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Post by brotherm1 on Feb 28, 2020 5:33:49 GMT -5
It’s all about pricing. The product cost too much. We should see with.Brazil. And selling larger quantities - albeit at lower prices in foreign countries - should enable MNKD to better be able to lower costs in the US. Right now MNkD has excess manufacturing capacity/costs ha - albeit MC just said in the Leerink presentation that the current strategy in Brazil is high priced cash India will be high volume low margin. Australia something like $200-$300 per month profit per patient (if I was able to interpret his language correctly). |
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Post by cretin11 on Feb 28, 2020 6:12:25 GMT -5
Yes Steve’s initials thank you:-) oops I think a post went missing. That’s what I get for not quoting. They are Steve‘s initials. Sports, I worded my question poorly. What I meant to ask: When Steve said “Things are moving for VDEX and investors will be more than pleased” was he referring to VDEX investors or MNKD investors? |
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Post by boca1girl on Feb 28, 2020 6:59:01 GMT -5
This thread has really gone off topic. Has anyone been able to confirm that the COO is “gone”?
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Post by tingtongtung on Feb 28, 2020 7:04:36 GMT -5
Looks like BS.. Stock twits says CCO Pat got a bunch of options along with CFO, gen counsel and CPO.
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Post by prcgorman2 on Feb 28, 2020 7:09:42 GMT -5
LOL. Glad I read the end intead of the whole thread although I got a lot of enjoyment out of rockstarrick’s posts. I’m partially deaf from an Emerson, Lake, and Palmer concert in a university field house. I was in the 3rd row.
Anyway, I didn’t like the CCO presentations I listened to last year so not to be mean or anything, but I would actually prefer that he was gone. Maybe we’ll get a SP bump?
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Post by sportsrancho on Feb 28, 2020 8:03:51 GMT -5
Yes Steve’s initials thank you:-) oops I think a post went missing. That’s what I get for not quoting. They are Steve‘s initials. Sports, I worded my question poorly. What I meant to ask: When Steve said “Things are moving for VDEX and investors will be more than pleased” was he referring to VDEX investors or MNKD investors? Oh, definitely Mannkind investors. |
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