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Post by peppy on Jan 8, 2018 8:28:53 GMT -5
clearly Sanofi failed to start a label change with the clamp data they had and failed to obtain health insurance for the drug. It is likely the only reason Sanofi did the clamp test at all was because they were contractually obligated to do so as part of the partnership agreement since it was an FDA requirement. Since by the time the results came out they had decided to leave they never progressed beyond what they were obliged to do by the letter of the contract. I don't particularly fault Sanofi for the insurance. That was always going to take time.Aged, my friend that wants pay 15 to 30 dollars out of pocket a month for the insulin he has to take; how do people get their insulin? through their health insurance? Please aged. How does anyone sell insulin with out having it covered by health insurance?
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Post by golfeveryday on Jan 8, 2018 8:40:40 GMT -5
respectfully disagree in a large way. Sny was selling and backed off. Mnkd has proven afrezza is a very promotionally sensitive drug, which works in spectacular fashion by the way. A partner will come on board at some point, likely soon. Here’s why. Mnkd Sales team is 7x smaller than a national sales team. Extrapolate existing sales to a national team. It would mean Breakeven and beyond very quickly. You cannot extrapolate sales teams like that. Mannkind has their sales teams in the best markets at the moment. It is the same problem USPS has - if you serve everywhere you lose money, if you serve a few key places you make money. Expand the sales teams and you get into diminishing returns. Mike knows what he is doing. even Mike made the 1/7 statement. Yes, diminishing returns at some point but they are from that point.
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Post by agedhippie on Jan 8, 2018 8:45:20 GMT -5
It is likely the only reason Sanofi did the clamp test at all was because they were contractually obligated to do so as part of the partnership agreement since it was an FDA requirement. Since by the time the results came out they had decided to leave they never progressed beyond what they were obliged to do by the letter of the contract. I don't particularly fault Sanofi for the insurance. That was always going to take time.Aged, my friend that wants pay 15 to 30 dollars out of pocket a month for the insulin he has to take; how do people get their insulin? through their health insurance? Please aged. How does anyone sell insulin with out having it covered by health insurance? Usually you get insulin via insurance. With the exception of a couple of states you can buy Regular and NPH across the counter but even that is going to be more than they want to spend. They can try the pharmas as well. They all have hardship programs in which case you get it for free. The important thing is going to be the type and quantity they need. Canadian pharmacies might be worth a try? The other option is samples. See if their doctor can get samples from the drug companies. What happens to people who fall through all these nets (and quite a lot do)? The end up in ER a lot getting their levels straightened out and the hospital gives them insulin when they get discharged. Of course when that insulin runs out they are back in the hospital again and the cycle repeats...
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Post by peppy on Jan 8, 2018 9:08:48 GMT -5
Aged, my friend that wants pay 15 to 30 dollars out of pocket a month for the insulin he has to take; how do people get their insulin? through their health insurance? Please aged. How does anyone sell insulin with out having it covered by health insurance? Usually you get insulin via insurance. With the exception of a couple of states you can buy Regular and NPH across the counter but even that is going to be more than they want to spend. They can try the pharmas as well. They all have hardship programs in which case you get it for free. The important thing is going to be the type and quantity they need. Canadian pharmacies might be worth a try? The other option is samples. See if their doctor can get samples from the drug companies. What happens to people who fall through all these nets (and quite a lot do)? The end up in ER a lot getting their levels straightened out and the hospital gives them insulin when they get discharged. Of course when that insulin runs out they are back in the hospital again and the cycle repeats... right. go to Walmart for nph. yep. Afrezza failed because it did not have insurance. Geez Loiuse.
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Post by mnkdfann on Jan 8, 2018 9:44:30 GMT -5
The presentation at Cantor conference had a slide covering patents. It said that the FDA Orange Book patents covering Afrezza extend to 2032. Even after that point it may be more difficult than a typical generic drug to replicate Afrezza since it is a complicated device drug combo. What would a company need to do to prove that their copycat cartridges, inhaler and powder (particle size, uniformity, etc.) perform exactly the same as Afrezza? Is there possibility a copycat would need to go through its own expensive set of clinical trials to prove equivalence? (don't know the answers to these questions) Concern for others copying Afrezza is very far down on my list of what I'm concerned about. I have to respectfully disagree with your post. The intellectual property behind Afrezza is what its all about. Re read the agreement with SNY and how important it was to SNY if they developed their own ability to develop a similar drug and how they would basically kick MNKD to the street (they did anyway) if they were successful. 2032 is only 14 years away. That is not a whole lot of time for a partner to bring the drug to blockbuster status in the current environment and have a sufficient runway to make profit to make it all worth while. The Cantor slide states "35 Patents listed in FDA’s Orange Book, Patent term extends to 2032 Trademark Registered in major markets". I believe they do not all expire in 2032. Some expire much sooner. In its 2014 2nd Q report, MNKD said "the term of a patent is limited and, as a result, the patents protecting our products expire at various dates. For example, some patents providing protection for our AFREZZA inhalation powder expired in 2012. Other patents providing similar protection have terms extending into 2020, 2030 and 2031. In addition, patents providing protection for our inhaler and cartridges have terms extending into 2023, 2031 and 2032, and we have method of treatment claims that extend into 2026 and 2029. As and when these different patents expire, AFREZZA could become subject to increased competition." So it is actually worse than you described.
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Post by cjm18 on Jan 8, 2018 10:34:34 GMT -5
So a generic could be created after just a few of the early patents expire?
If someone wants to spend the resources and manpower to create a generic version then that means afrezza was quite successful.
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Post by madog365 on Jan 8, 2018 10:40:24 GMT -5
I have to respectfully disagree with your post. The intellectual property behind Afrezza is what its all about. Re read the agreement with SNY and how important it was to SNY if they developed their own ability to develop a similar drug and how they would basically kick MNKD to the street (they did anyway) if they were successful. 2032 is only 14 years away. That is not a whole lot of time for a partner to bring the drug to blockbuster status in the current environment and have a sufficient runway to make profit to make it all worth while. The Cantor slide states "35 Patents listed in FDA’s Orange Book, Patent term extends to 2032 Trademark Registered in major markets". I believe they do not all expire in 2032. Some expire much sooner. In its 2014 2nd Q report, MNKD said "the term of a patent is limited and, as a result, the patents protecting our products expire at various dates. For example, some patents providing protection for our AFREZZA inhalation powder expired in 2012. Other patents providing similar protection have terms extending into 2020, 2030 and 2031. In addition, patents providing protection for our inhaler and cartridges have terms extending into 2023, 2031 and 2032, and we have method of treatment claims that extend into 2026 and 2029. As and when these different patents expire, AFREZZA could become subject to increased competition." So it is actually worse than you described. Absolutely ridiculous and unnecessary fear mongering. Patent expiration is the least of our worries.
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Post by zuegirdor on Jan 8, 2018 11:44:35 GMT -5
The Cantor slide states "35 Patents listed in FDA’s Orange Book, Patent term extends to 2032 Trademark Registered in major markets". I believe they do not all expire in 2032. Some expire much sooner. In its 2014 2nd Q report, MNKD said "the term of a patent is limited and, as a result, the patents protecting our products expire at various dates. For example, some patents providing protection for our AFREZZA inhalation powder expired in 2012. Other patents providing similar protection have terms extending into 2020, 2030 and 2031. In addition, patents providing protection for our inhaler and cartridges have terms extending into 2023, 2031 and 2032, and we have method of treatment claims that extend into 2026 and 2029. As and when these different patents expire, AFREZZA could become subject to increased competition." So it is actually worse than you described. Absolutely ridiculous and unnecessary fear mongering. Patent expiration is the least of our worries. So what should we be worried about?
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Post by dreamboatcruise on Jan 8, 2018 11:57:49 GMT -5
Absolutely ridiculous and unnecessary fear mongering. Patent expiration is the least of our worries. So what should we be worried about? Looking out to 2032? I'd worry as much about something that looks more like a cure for diabetes... rejuvenating or implanting beta cells perhaps, stopping the immune system attack for T1s. Short term it's the financing. If all goes well MNKD can likely navigate with dilutive funding, but always risk that outside forces (such as a market crash) could throw a spanner in the works. Insurance coverage is something I assume is high on the concern list for management. Or simply don't worry at all. If you've placed your bet and intend to stick with current position no matter what, then worrying in general would seem counter productive.
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Post by mytakeonit on Jan 8, 2018 13:13:12 GMT -5
What we should be worried about is people rushing to buy MNKD and the share price climbing so fast that we can't buy more !!! Aaarrrgghhh !!!
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Post by cedafuntennis on Jan 8, 2018 13:39:15 GMT -5
Cash and insurance coverage we should be worried about. Patents would be a blessing if they were to become a concern as that would indicate success.
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Post by mnkdfann on Jan 8, 2018 13:59:19 GMT -5
The Cantor slide states "35 Patents listed in FDA’s Orange Book, Patent term extends to 2032 Trademark Registered in major markets". I believe they do not all expire in 2032. Some expire much sooner. In its 2014 2nd Q report, MNKD said "the term of a patent is limited and, as a result, the patents protecting our products expire at various dates. For example, some patents providing protection for our AFREZZA inhalation powder expired in 2012. Other patents providing similar protection have terms extending into 2020, 2030 and 2031. In addition, patents providing protection for our inhaler and cartridges have terms extending into 2023, 2031 and 2032, and we have method of treatment claims that extend into 2026 and 2029. As and when these different patents expire, AFREZZA could become subject to increased competition." So it is actually worse than you described. Absolutely ridiculous and unnecessary fear mongering. Patent expiration is the least of our worries. I don't want to dwell on this issue. I agree patent expiration is not the main worry. But I was merely responding and correcting posts by others. As for fear mongering, please note I was only quoting what MNKD itself said about its patents.
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Post by kc on Jan 8, 2018 14:17:19 GMT -5
Absolutely ridiculous and unnecessary fear mongering. Patent expiration is the least of our worries. So what should we be worried about? Dinner tonight at #JPM2018.... Who is Locust walk and Mike meeting and what are they discussing at dinner.
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Post by MnkdWASmyRtrmntPlan on Jan 8, 2018 22:31:50 GMT -5
Maybe I just read your comment differently than you intended it, but technically, Sanofi didn't fail to sell it; they just stopped selling it. They were selling it fine until they stopped trying. Sanofi's new replacement CEO didn't want to sell it. All the "big players" as you call them know that. In fact, they know that and think about Afrezza even more than we do. And, you are correct that things are different now. We're in the age of CGM's now, and Afrezza is the only shining star in that arena. If any of the big players were wringing their hands in fear of Afrezza, they would have bought us out. Afrezza is a fantastic breakthrough product, but while sales are low, I doubt it's taken as a serious competitor. It is investors like us and people whose lives have been transformed by Afrezza that think about it. I hope I am wrong and a deal is announced tomorrow. :-) Nobody has bought us out because MNKD knows their value, so they expect much more money than buyers are willing to pay, especially considering the current sales. I don't really ever expect a buyout. But, a BP is very possible. You're right, sales are low, and that has been slow improvement so far. But, sales are on an increasing trajectory and there are impending factors that will be very beneficial to sales: CGM's, improved insurance coverage, diabetes continues to increase, Pediatrics, Vdex. Although MNKD has a large, long hurdle ahead of it (to keep pushing forward toward the breakeven point while staying solvent), they have proven impressive in that regard so far (albeit, share-price has not been impressive yet). Sales have always been MNKD's major hurdle. I believe that will be changing this year.
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Post by falconquest on Jan 9, 2018 7:28:40 GMT -5
If any of the big players were wringing their hands in fear of Afrezza, they would have bought us out. Afrezza is a fantastic breakthrough product, but while sales are low, I doubt it's taken as a serious competitor. It is investors like us and people whose lives have been transformed by Afrezza that think about it. I hope I am wrong and a deal is announced tomorrow. :-) Nobody has bought us out because MNKD knows their value, so they expect much more money than buyers are willing to pay, especially considering the current sales. I don't really ever expect a buyout. But, a BP is very possible. You're right, sales are low, and that has been slow improvement so far. But, sales are on an increasing trajectory and there are impending factors that will be very beneficial to sales: CGM's, improved insurance coverage, diabetes continues to increase, Pediatrics, Vdex. Although MNKD has a large, long hurdle ahead of it (to keep pushing forward toward the breakeven point while staying solvent), they have proven impressive in that regard so far (albeit, share-price has not been impressive yet). Sales have always been MNKD's major hurdle. I believe that will be changing this year. So are you saying that Mike has had multiple offers and turned them down because they were too low?
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