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Post by timri on Feb 6, 2018 19:25:49 GMT -5
Ultra rapid insulin and nasal glucagon caught my eyes.
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Post by sayhey24 on Feb 6, 2018 19:43:48 GMT -5
Ultra rapid insulin is their version of Fiasp which afrezza obsoleted nasal glucagon is obsoleted by afrezza's ability to restore hepatic function Their big new top seller is trulicity There is some discussion that this class of drugs is so unsafe the entire class will be pulled. There is a suit in the 9th circuit which should be ruled on soon concerning Januvia, Byetta and Victoza over pancreatic cancer and pancreatitis. Here is a good summary on it - www.drugwatch.com/januvia/litigation/ and an update www.law.com/americanlawyer/sites/therecorder/2017/10/11/9th-circuit-eyes-preemption-of-state-law-claims-over-pharma-labeling/?slreturn=20180106194219As bad as these are Trulicity may be even worse, if thats possible. It already comes with an FDA ‘black box’ warning about its risks of medullary thyroid cancer and other thyroid tumours. It was approved on the basis of just five small clinical trials (less than is usual for this kind of drug). The FDA has required the Eli Lilly to carry out five ‘post-marketing studies’, including an assessment of cardiovascular risks in people with type 2 diabetes as there is concern it may cause heart attacks too.
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Post by golfeveryday on Feb 6, 2018 19:44:51 GMT -5
C raig Dean@ Michael Kovacocy think any chance this article from a week ago about Lilly having 9 billion from the new tax plan to spend on acquisitions and partnerships And the new hire today from Lilly is associated? Might be nothing but interesting regardless. Michael Kovacocy
Craig Dean that is some good sleuthing and interesting. I can't comment with certainty on speculation, and if I did know anything specific on this point, I wouldn't be able to comment. So it is clear that I will just have to defer to you and say that it is certainly plausible, why not? Michael Kovacocy
I would say this. And it isn't rocket science. Mike the CEO continues to deliver what he promised, and is ticking off all the boxes on the company's to do list. This is public info, the list is on loads of presentations, etc. And there are now just a few tick boxes left on the list, and they are biggies. One relating to the subject you have mentioned above. So if I were a betting man, I would expect material news on this point sooner than later. And there is nothing to say that your speculation has any more or less merit than that of others with less optimistic views on the company. I would even be so inclined to say that your thesis makes sense - not so much just for Lilly, but a whole swath of players who might wish to cosy up to MNKD. So the general thrust of your thesis makes sense. Might not be the right company, but makes sense. Holy moly! i have never thought Lilly was in play really and think anything other than a BO scenario with a player like that could be risky. That being said, as progress is made, I would imagine many companies have been taking notice and you never know who could feel the pressure and get very motivated to make aggressive moves with MNKD. Interesting times ahead.
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Post by sportsrancho on Feb 6, 2018 20:17:47 GMT -5
Ultra rapid insulin is their version of Fiasp which afrezza obsoleted nasal glucagon is obsoleted by afrezza's ability to restore hepatic function Their big new top seller is trulicity There is some discussion that this class of drugs is so unsafe the entire class will be pulled. There is a suit in the 9th circuit which should be ruled on soon concerning Januvia, Byetta and Victoza over pancreatic cancer and pancreatitis. Here is a good summary on it - www.drugwatch.com/januvia/litigation/ and an update www.law.com/americanlawyer/sites/therecorder/2017/10/11/9th-circuit-eyes-preemption-of-state-law-claims-over-pharma-labeling/?slreturn=20180106194219As bad as these are Trulicity may be even worse, if thats possible. It already comes with an FDA ‘black box’ warning about its risks of medullary thyroid cancer and other thyroid tumours. It was approved on the basis of just five small clinical trials (less than is usual for this kind of drug). The FDA has required the Eli Lilly to carry out five ‘post-marketing studies’, including an assessment of cardiovascular risks in people with type 2 diabetes as there is concern it may cause heart attacks too. I see commercials about this lawsuit on TV all the time. I shouldn’t call them commercials I guess, I keep trying to get a picture but I’m always too late.
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Post by madog365 on Feb 6, 2018 20:46:25 GMT -5
Lilly was once developing their own version of inhaled insulin but ultimately abandoned it before completing phase III trials. "Indianapolis-based Lilly said its decision was not due to safety concerns, “but rather was a result of increasing uncertainties in the regulatory environment, and a thorough evaluation of the evolving commercial and clinical potential of the product compared to existing medical therapies.” Lilly Chief Operating Officer John Lechleiter said in a statement that the company is beginning the process of halting ongoing clinical studies. www.reuters.com/article/us-alkermes-insulin/eli-lilly-drops-inhaled-insulin-program-idUSN0732561420080307-- That was in 2008 and John Lechleiter later became CEO of Eli Lilly and retired approximately a year ago in 2017. Who knows, maybe the new leadership now see's afrezza as a superior insulin compared to what they were once developing and "existing medical therapies" in the market today.
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Post by sayhey24 on Feb 6, 2018 20:47:16 GMT -5
They are a mess and Trulicity may actually be the worst. The lawsuit is not about the fact these drugs cause serious issues. The companies admit to that. The suit is about the fact that since the FDA did not require them to disclose on the label how bad they are its the FDA's fault and they are not responsible.
IMO they should all be pulled and tell the PWD to eat higher fat meals or take afrezza. But then it gets worse with Jardiance. How many commercials are telling us its heart healthy? Too bad they are not telling us people are losing toes, feet, fingers and limbs thanks to this heart healthy mess.
If they want to get heart healthy lets approach non-diabetic TIR and save a few toes.
Maybe that's why Kendall is here. Maybe he too is tired of all these companies pushing these very dangerous concoctions. I sure hope he knows how to sell.
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Post by madog365 on Feb 6, 2018 20:57:25 GMT -5
Thought this was a nice writeup (some outdated info) but it seems he left on good terms since he got a farewell statement from Lilly. www.fiercepharma.com/pharma/top-lilly-diabetes-exec-becomes-cmo-at-mannkind"MannKind, which continues to try to convince the market of the value of its inhaled insulin, has enticed a top scientific executive away from Eli Lilly as it explores new areas for the fast-acting drug"
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Post by sayhey24 on Feb 6, 2018 20:58:31 GMT -5
madog365 - Lily saw afrezza as a superior insulin compared to what they were once developing back in 2008. So did Pfizer and that was the reason they pulled Exubera. They did not want to make the inhaled market only to have afrezza approved in the next year and take the whole damn thing.
They all believed at that point Al too would give up with the cancer FUD and MNKD would go bankrupt. Its now 2018 and MNKD was suppose to be long gone and afrezza long forgotten.
IMO any relationship with Lily unless a straight up buyout is a huge mistake. afrezza obsoletes most of their present and future products.
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Post by gamblerjag on Feb 6, 2018 21:04:18 GMT -5
Lilly was once developing their own version of inhaled insulin but ultimately abandoned it before completing phase III trials. "Indianapolis-based Lilly said its decision was not due to safety concerns, “but rather was a result of increasing uncertainties in the regulatory environment, and a thorough evaluation of the evolving commercial and clinical potential of the product compared to existing medical therapies.” Lilly Chief Operating Officer John Lechleiter said in a statement that the company is beginning the process of halting ongoing clinical studies. www.reuters.com/article/us-alkermes-insulin/eli-lilly-drops-inhaled-insulin-program-idUSN0732561420080307-- That was in 2008 and John Lechleiter later became CEO of Eli Lilly and retired approximately a year ago in 2017. Who knows, maybe the new leadership now see's afrezza as a superior insulin compared to what they were once developing and "existing medical therapies" in the market today. is the new CMO one of the things that gets checked off on the list of all the things mankind needs to accomplish?Haven't seen the list in a while I forget who is the one that developed it thanks
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Post by agedhippie on Feb 6, 2018 21:12:05 GMT -5
Ultra rapid insulin is their version of Fiasp which afrezza obsoleted nasal glucagon is obsoleted by afrezza's ability to restore hepatic function Their big new top seller is trulicity There is some discussion that this class of drugs is so unsafe the entire class will be pulled. There is a suit in the 9th circuit which should be ruled on soon concerning Januvia, Byetta and Victoza over pancreatic cancer and pancreatitis. Here is a good summary on it - www.drugwatch.com/januvia/litigation/ and an update www.law.com/americanlawyer/sites/therecorder/2017/10/11/9th-circuit-eyes-preemption-of-state-law-claims-over-pharma-labeling/?slreturn=20180106194219As bad as these are Trulicity may be even worse, if thats possible. It already comes with an FDA ‘black box’ warning about its risks of medullary thyroid cancer and other thyroid tumours. It was approved on the basis of just five small clinical trials (less than is usual for this kind of drug). The FDA has required the Eli Lilly to carry out five ‘post-marketing studies’, including an assessment of cardiovascular risks in people with type 2 diabetes as there is concern it may cause heart attacks too. You are confusing GLP-1, Trulicity, with DPP-4, all the others you give - these are different classes. There is no lawsuit against Trulicity. There is a lawsuit against the DPP-4 drugs although it's currently awaiting appeal three years after the drug companies were granted a summary judgement against the ambulance chasers plaintiffs in the class action. There is no chance that DPP-4 as a class gets withdrawn and I am curious where you got the idea that it would be. Mannkind had to carry out four post marketing studies, one of which was " a 5-year, randomized, controlled trial in 8,000-10,000 patients with type 2 diabetes to assess the serious potential risk of pulmonary malignancy with Afrezza use". Do you believe lung cancer as a serious issue with Afrezza because there is post marketing trial required because I don't? All new diabetes drugs used for Type 2 require that cardiovascular study, including Afrezza. In Afrezza's case it is part of the lung cancer trial (" The trial must also include an assessment of cardiovascular risk based on prospectively defined, collected and independently adjudicated major adverse cardiovascular events or MACE") rather than a separate study - that's the FDA playing nice and letting Mannkind bundle trials to reduce costs. I am no fan of diabetes drugs by and large but let's keep a sense of perspective.
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Post by straightly on Feb 6, 2018 21:34:31 GMT -5
Might be analyzing it too much... Possibly. But written words i always assume carry greater substance than those spoken. As these kinds of things are edited to say exactly what is intended, whereas verbally (in interviews and such) thoughts and ideas usually (almost always) aren't as well thought out. HUMOROUS NOTE: I've edited this post 3 times now and it still isn't how i'd like it (used the word 'thought' twice in last part of it) Since you wanted to analyze this to death, you missed the part that there are one grammar error: verbally is an adverb which got put in front of nouns. Then there is no such things as verbal thoughts and ideas. There are only verbal words. Now, I have to admit my English is not very WELL, though my Chinese is more bad.
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Post by kc on Feb 6, 2018 21:49:21 GMT -5
They are a mess and Trulicity may actually be the worst. The lawsuit is not about the fact these drugs cause serious issues. The companies admit to that. The suit is about the fact that since the FDA did not require them to disclose on the label how bad they are its the FDA's fault and they are not responsible. IMO they should all be pulled and tell the PWD to eat higher fat meals or take afrezza. But then it gets worse with Jardiance. How many commercials are telling us its heart healthy? Too bad they are not telling us people are losing toes, feet, fingers and limbs thanks to this heart healthy mess. If they want to get heart healthy lets approach non-diabetic TIR and save a few toes. Maybe that's why Kendall is here. Maybe he too is tired of all these companies pushing these very dangerous concoctions. I sure hope he knows how to sell. Maybe you hit the point Afrezza is not a CONCOCTION... it is INSULIN. I find it strange that he left Lilly so fast that he didn’t correct his linkedin page. I know that Lilly had some layoff’s last year but not sure in what areas the layoff’s occurred. But most people who have left a company update their LinkedIn site in a timely fashion. he was there back in October 2017 Spend some time on the Lilly Diabetes web site. They really are a fine company with a history of leadership in the Diabetes space. It’s a very good history. www.lillydiabetes.com/heritage.aspxI would not be afraid of a Buy In by Lilly for the international rights. Say they purchased 20% of the company with newly minted shares for $20.00 per share. MannKind retains domestic United States rights and Lilly gets the Worldwide distribution rights. MannKind keeps the manufacturing of Afrezza. MannKind shares would rocket up immediately to $20.00 and burn all the shorts. Last year according to the Lilly Investor relations site they did an investment conference at a company event Leerink Partners Global Health Conference. That event was February 16th, 2017. The presenter was Enrique Conterno, Sr VP and President — Lilly Diabetes. Conterno is Now Lilly US President. The 28:57 minute presentation is still on their web page. Moving forward one year they are presenting again at Leerink Partners on February 15, 2018. What are they presenting this year? Nobody knows. I have circled my Calendar for February 12th as it seems like a Monday Pre-Market would be a good time for any important announcement from MannKind if there is something to report. I am not SPECULATING there that would be any news. It’s just a good day for news if there is any to report.
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Post by babaoriley on Feb 7, 2018 0:09:34 GMT -5
Possibly. But written words i always assume carry greater substance than those spoken. As these kinds of things are edited to say exactly what is intended, whereas verbally (in interviews and such) thoughts and ideas usually (almost always) aren't as well thought out. HUMOROUS NOTE: I've edited this post 3 times now and it still isn't how i'd like it (used the word 'thought' twice in last part of it) Since you wanted to analyze this to death, you missed the part that there are one grammar error: verbally is an adverb which got put in front of nouns. Then there is no such things as verbal thoughts and ideas. There are only verbal words. Now, I have to admit my English is not very WELL, though my Chinese is more bad. Straightly, your disclaimer notwithstanding, you can't call another out and make an awful error in doing so, it just ruins the effect. "Are" should be "is."
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Post by mytakeonit on Feb 7, 2018 1:07:36 GMT -5
All I can say is ... shorts ... you have been warned !!! The team is in place and we are going to be ... helping all diabetics whether you like it or not. Last chance to get out !!! You took a couple of penys from me ... but today we got a nickel. So, you can suck my ... ... Afrezza inhaler!!! GO MNKD !!!
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Post by tingtongtung on Feb 7, 2018 1:09:01 GMT -5
They are a mess and Trulicity may actually be the worst. The lawsuit is not about the fact these drugs cause serious issues. The companies admit to that. The suit is about the fact that since the FDA did not require them to disclose on the label how bad they are its the FDA's fault and they are not responsible. IMO they should all be pulled and tell the PWD to eat higher fat meals or take afrezza. But then it gets worse with Jardiance. How many commercials are telling us its heart healthy? Too bad they are not telling us people are losing toes, feet, fingers and limbs thanks to this heart healthy mess. If they want to get heart healthy lets approach non-diabetic TIR and save a few toes. Maybe that's why Kendall is here. Maybe he too is tired of all these companies pushing these very dangerous concoctions. I sure hope he knows how to sell. Maybe you hit the point Afrezza is not a CONCOCTION... it is INSULIN. I find it strange that he left Lilly so fast that he didn’t correct his linkedin page. I know that Lilly had some layoff’s last year but not sure in what areas the layoff’s occurred. But most people who have left a company update their LinkedIn site in a timely fashion. he was there back in October 2017 Spend some time on the Lilly Diabetes web site. They really are a fine company with a history of leadership in the Diabetes space. It’s a very good history. www.lillydiabetes.com/heritage.aspxI would not be afraid of a Buy In by Lilly for the international rights. Say they purchased 20% of the company with newly minted shares for $20.00 per share. MannKind retains domestic United States rights and Lilly gets the Worldwide distribution rights. MannKind keeps the manufacturing of Afrezza. MannKind shares would rocket up immediately to $20.00 and burn all the shorts. Last year according to the Lilly Investor relations site they did an investment conference at a company event Leerink Partners Global Health Conference. That event was February 16th, 2017. The presenter was Enrique Conterno, Sr VP and President — Lilly Diabetes. Conterno is Now Lilly US President. The 28:57 minute presentation is still on their web page. Moving forward one year they are presenting again at Leerink Partners on February 15, 2018. What are they presenting this year? Nobody knows. I have circled my Calendar for February 12th as it seems like a Monday Pre-Market would be a good time for any important announcement from MannKind if there is something to report. I am not SPECULATING there that would be any news. It’s just a good day for news if there is any to report. Damn! Thats a nice thesis.. I truly, truly hope that this will not become the type of stuff we went thru a few years back (during earnings, mannkind website is not loading, mannkindtechnologies website is not loading, etc, etc). So much of my money is stuck in MNKD, I couldn't risk any more money to buy stuff yesterday.. Please, MNKD for $53 :-)
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