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Post by ktim on Jan 7, 2020 14:21:03 GMT -5
So, for those that were familiar with the prior SOC, does this new one show anything new and more positive for Aftezza that should help with sales/insurance? Doesn't seem the changes in Afrezza mention are huge deals, though every little bit helps when it is clarifying and representing Afrezza more on par with RAA as an option. One thing that should probably be looked at as important as the actual references to Afrezza would be any changes in discussion of treatment goals. Is there any further shift to talking about TIR and post prandial excursions as metrics that should be treated to. Some people I'm sure are hoping that one day there'll be an SoC release and all of a sudden Afrezza will be the "preferred" first use prandial. I think best case is that ADA starts emphasizing TIR and BG excursions more. MNKD can then likely use their under powered studies to gain some traction and eventually plan for larger trials that might actually put Afrezza in the mainstream spotlight.
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Post by goyocafe on Jan 7, 2020 14:37:17 GMT -5
Huevos? Cajones? Bullocks? Cobblers? MC, take your pick, but pick a pair!!! Pick a fight with the FDA as Al did? If Kendall is all that everyone thinks he is and he has the easiest job ever due to the fact that all the science is already there, then it would not be a “fight “, but rather an appeal based on what’s been shown already. The Adcom was the first sign that the FDA needed to be educated on the attributes of Afrezza that distinguishes it from other insulin. It seems to me that the struggles MNKD has is multi-pronged. Taking the science back to the FDA for further review is not picking a fight, imo.
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Post by sayhey24 on Jan 7, 2020 18:54:51 GMT -5
Pick a fight with the FDA as Al did? If Kendall is all that everyone thinks he is and he has the easiest job ever due to the fact that all the science is already there, then it would not be a “fight “, but rather an appeal based on what’s been shown already. The Adcom was the first sign that the FDA needed to be educated on the attributes of Afrezza that distinguishes it from other insulin. It seems to me that the struggles MNKD has is multi-pronged. Taking the science back to the FDA for further review is not picking a fight, imo. Promoting off-label use of afrezza is not a fight which MNKD will have as Amarin Pharmaceuticals already picked that fight with the FDA and won. As long as MNKD has studies to back up the claim of fewer hypos Mike's new sale guys have clear sailing promoting this off-label information. I know there are some on this board who don't like the idea of any good news for MNKD but MNKD is good to go on this without a label change and that is the way it is. I also see the new SoC wording as a significant step forward for afrezza promotion in the T1 community. "Inhaled human insulin has a rapid peak and shortened duration of action compared with RAA and may cause less hypoglycemia and weight gain A pilot study found evidence that compared with injectable rapid-acting insulin, supplemental doses of inhaled insulin taken based on postprandial glucose levels may improve blood glucose management without additional hypoglycemia or weight gain". The only thing better would be a large scale study to back up the pilot study and if I remember correctly that PR came out a few weeks back and Mike said it will be presented in February. As far as Al picking a fight with the FDA, nothing could be farther from the truth. Al bent so far over backwards that he let the FDA design the 171/175 studies. MNKD's problem was and still is the fix was in with the FDA and BP and BP was going to do whatever it could to stop afrezza approval. All Al wanted was an already approved drug "human insulin" re-approved for use with the inhaler. Even the Chinese chemist thought afrezza was approved prior to the second CRL and this guy had access to the approved drug database. The fact is Al was given a heads-up to request the Adcom so he could get a public vote. Without that Adam Feuerstein would have been correct and afrezza would have been doomed.
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Post by mango on Jan 7, 2020 19:15:02 GMT -5
If Kendall is all that everyone thinks he is and he has the easiest job ever due to the fact that all the science is already there, then it would not be a “fight “, but rather an appeal based on what’s been shown already. The Adcom was the first sign that the FDA needed to be educated on the attributes of Afrezza that distinguishes it from other insulin. It seems to me that the struggles MNKD has is multi-pronged. Taking the science back to the FDA for further review is not picking a fight, imo. Promoting off-label use of afrezza is not a fight which MNKD will have as Amarin Pharmaceuticals already picked that fight with the FDA and won. As long as MNKD has studies to back up the claim of fewer hypos Mike's new sale guys have clear sailing promoting this off-label information. I know there are some on this board who don't like the idea of any good news for MNKD but MNKD is good to go on this without a label change and that is the way it is. I also see the new SoC wording as a significant step forward for afrezza promotion in the T1 community. "Inhaled human insulin has a rapid peak and shortened duration of action compared with RAA and may cause less hypoglycemia and weight gain A pilot study found evidence that compared with injectable rapid-acting insulin, supplemental doses of inhaled insulin taken based on postprandial glucose levels may improve blood glucose management without additional hypoglycemia or weight gain". The only thing better would be a large scale study to back up the pilot study and if I remember correctly that PR came out a few weeks back and Mike said it will be presented in February. As far as Al picking a fight with the FDA, nothing could be farther from the truth. Al bent so far over backwards that he let the FDA design the 171/175 studies. MNKD's problem was and still is the fix was in with the FDA and BP and BP was going to do whatever it could to stop afrezza approval. All Al wanted was an already approved drug "human insulin" re-approved for use with the inhaler. Even the Chinese chemist thought afrezza was approved prior to the second CRL and this guy had access to the approved drug database. The fact is Al was given a heads-up to request the Adcom so he could get a public vote. Without that Adam Feuerstein would have been correct and afrezza would have been doomed. This here is shaping things up for our new Ultra Acting category, IMO: ”Inhaled human insulin has a rapid peak and shortened duration of action compared with RAA and may cause less hypoglycemia and weight gain” We can’t expect a lot from ADA and the SoC writers and editors considering it is a Pay for Play game and MannKind has made it clear they ain’t paying to play their game. 💪
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Post by ktim on Jan 7, 2020 19:39:22 GMT -5
Pick a fight with the FDA as Al did? If Kendall is all that everyone thinks he is and he has the easiest job ever due to the fact that all the science is already there, then it would not be a “fight “, but rather an appeal based on what’s been shown already. The Adcom was the first sign that the FDA needed to be educated on the attributes of Afrezza that distinguishes it from other insulin. It seems to me that the struggles MNKD has is multi-pronged. Taking the science back to the FDA for further review is not picking a fight, imo. Taking info to the FDA for review of course wouldn't be picking a fight. They've done that already and likely to continue as new data arises. But some here are advocating MNKD stepping forward as a leader in pushing back on FDA controls on drug marketing by simply doing it even if it means then fighting FDA in courts. MNKD is dependent on future rulings by FDA. Sadly, FDA is not above being "punitive". Al criticized FDA. Some feel that was part of the reason FDA caused problems for MNKD. There's pediatric, TreT and pipeline to worry about. I really think that lawsuit is a bit of a distraction because it was about off-label indications. My understanding is that MNKD has had the ability to distribute published papers within the medical community pertaining to adult use of Afrezza in T1 and T2 without needing to rely on that limited ruling. Reps in general are very limited in what they can say about the scientific lit but can always encourage doctors to contact MNKD medical affairs group with questions. As for marketing aimed at consumers, the FDA isn't going to cede that control anytime soon. And a small company would be crazy to challenge them. MNKD should make further trials a priority and play nice with the FDA.
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Post by sayhey24 on Jan 7, 2020 20:15:34 GMT -5
ktim - the FDA has already seen the study results. afrezza causing fewer hypos is well socialized and even got into the SoC. Remember the FDA would not give the ultra acting class because it was not recognized by "the community". As Mango correctly points out and Mike mentioned, we are now getting close.
I would be surprised if some of that $5M Mike just got is not for label updates after the ADA recognizes the Ultra acting class.
2020 is the year of the Endo promoting afrezza use by T1s. Selling this year is not to consumers, its to the endos. By year-end 2020 the India and Baltimore studies will be complete for 2021 T2 promotion.
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Post by brotherm1 on Jan 7, 2020 21:24:41 GMT -5
Sayhey, would you know if these two studies are large or should we expect a new SOC to again say no large studies have been completed?
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Post by agedhippie on Jan 7, 2020 23:12:49 GMT -5
ktim - the FDA has already seen the study results. afrezza causing fewer hypos is well socialized and even got into the SoC. Remember the FDA would not give the ultra acting class because it was not recognized by "the community". As Mango correctly points out and Mike mentioned, we are now getting close. I would be surprised if some of that $5M Mike just got is not for label updates after the ADA recognizes the Ultra acting class. 2020 is the year of the Endo promoting afrezza use by T1s. Selling this year is not to consumers, its to the endos. By year-end 2020 the India and Baltimore studies will be complete for 2021 T2 promotion. I am curious why you think endos are going to start promoting Afrezza by T1s more now and didn't do it last year.
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Post by slugworth008 on Jan 7, 2020 23:49:20 GMT -5
ktim - the FDA has already seen the study results. afrezza causing fewer hypos is well socialized and even got into the SoC. Remember the FDA would not give the ultra acting class because it was not recognized by "the community". As Mango correctly points out and Mike mentioned, we are now getting close. I would be surprised if some of that $5M Mike just got is not for label updates after the ADA recognizes the Ultra acting class. 2020 is the year of the Endo promoting afrezza use by T1s. Selling this year is not to consumers, its to the endos. By year-end 2020 the India and Baltimore studies will be complete for 2021 T2 promotion. I am curious why you think endos are going to start promoting Afrezza by T1s more now and didn't do it last year. Because it's their New Years resolution ??
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Post by peppy on Jan 7, 2020 23:54:31 GMT -5
ktim - the FDA has already seen the study results. afrezza causing fewer hypos is well socialized and even got into the SoC. Remember the FDA would not give the ultra acting class because it was not recognized by "the community". As Mango correctly points out and Mike mentioned, we are now getting close. I would be surprised if some of that $5M Mike just got is not for label updates after the ADA recognizes the Ultra acting class. 2020 is the year of the Endo promoting afrezza use by T1s. Selling this year is not to consumers, its to the endos. By year-end 2020 the India and Baltimore studies will be complete for 2021 T2 promotion. I am curious why you think endos are going to start promoting Afrezza by T1s more now and didn't do it last year.I was under the impression, that when physicians see a medication work extremely well for their patients and their patients are happier; is the reason physicians put more of their patients on that medication. That and health insurance coverage. sorry about that run on sentence above.
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Post by ktim on Jan 8, 2020 1:39:24 GMT -5
ktim - the FDA has already seen the study results. afrezza causing fewer hypos is well socialized and even got into the SoC. Remember the FDA would not give the ultra acting class because it was not recognized by "the community". As Mango correctly points out and Mike mentioned, we are now getting close. I would be surprised if some of that $5M Mike just got is not for label updates after the ADA recognizes the Ultra acting class. 2020 is the year of the Endo promoting afrezza use by T1s. Selling this year is not to consumers, its to the endos. By year-end 2020 the India and Baltimore studies will be complete for 2021 T2 promotion. Never said they aren't working on and accomplishing dissemination of the new info. Just that FDA still has restrictions on how that is done, and IMO a bad idea to try to make an end run on yet unsettled legal grounds. I will be pleasantly surprised if there is a new class introduced by FDA anytime soon, but that smells a bit like other smoke blowing exercises from management. If it does happen soon I'd be willing to bet more the efforts of Novo than MNKD (money talks more than data). Plus I think everyone's assumption that insurers will then somehow be forced to put it on unrestricted best tier treatment is a pipe dream. You can stick those predictions away in case I turn out to be wrong. I don't mind being reminded of when I do make incorrect predictions. Reviewing past errors helps improve analysis ability. Keeps me from making the same wrong predictions over and over. Totally agree 2020 is the year to sell Endos on Afrezza... as were 2019, 2018, 2017, 2016, 2015 and 2014. Hopefully this will be the best year yet in that long uphill battle.
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Post by sayhey24 on Jan 8, 2020 6:37:37 GMT -5
ktim - the FDA has already seen the study results. afrezza causing fewer hypos is well socialized and even got into the SoC. Remember the FDA would not give the ultra acting class because it was not recognized by "the community". As Mango correctly points out and Mike mentioned, we are now getting close. I would be surprised if some of that $5M Mike just got is not for label updates after the ADA recognizes the Ultra acting class. 2020 is the year of the Endo promoting afrezza use by T1s. Selling this year is not to consumers, its to the endos. By year-end 2020 the India and Baltimore studies will be complete for 2021 T2 promotion. I am curious why you think endos are going to start promoting Afrezza by T1s more now and didn't do it last year. Aged - I am not "thinking" it. This is what Mike said his plan was. Why now? Several reasons, here are a few; Mike has a few years of experience and has learned from his failures; CGM's have now come of age and every endo now has experience with them; As a result realtime BG, CGM numbers matter and A1c not so much; afrezza is the only real time solution and CGMs let you see those results - seeing is believing; afrezza lung safety has had outstanding results with some seeing improved FEV1; MNKD now has a large T1 study result analysis to couple with the STAT results; Dr. Kendall moved the "Borge" and got meaningful words in the SoC; hypos, hypos, hypos and afrezza will reduce them is something Endos understand; AND the kids will be approved later this year. Once you have the kids day 1 they will be afrezza users for life. Mike is going to hit the endos early and hard in preparing for the kids. No one wants kids getting hypos, especially their moms. Aged - have you ever dealt with "soccer moms"? I have and I think moms of T1s have a greater passion.
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Post by sayhey24 on Jan 8, 2020 6:40:20 GMT -5
Sayhey, would you know if these two studies are large or should we expect a new SOC to again say no large studies have been completed? India is the large T2 study - hopefully Dr. Kendall is fully engaged in the design. It would be nice to seem them leveraging Onduo and Onduo's partner Dexcom.
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Post by prcgorman2 on Jan 8, 2020 7:25:34 GMT -5
I am curious why you think endos are going to start promoting Afrezza by T1s more now and didn't do it last year. Aged - I am not "thinking" it. This is what Mike said his plan was. Why now? Several reasons, here are a few; Mike has a few years of experience and has learned from his failures; CGM's have now come of age and every endo now has experience with them; As a result realtime BG, CGM numbers matter and A1c not so much; afrezza is the only real time solution and CGMs let you see those results - seeing is believing; afrezza lung safety has had outstanding results with some seeing improved FEV1; MNKD now has a large T1 study result analysis to couple with the STAT results; Dr. Kendall moved the "Borge" and got meaningful words in the SoC; hypos, hypos, hypos and afrezza will reduce them is something Endos understand; AND the kids will be approved later this year. Once you have the kids day 1 they will be afrezza users for life. Mike is going to hit the endos early and hard in preparing for the kids. No one wants kids getting hypos, especially their moms. Aged - have you ever dealt with "soccer moms"? I have and I think moms of T1s have a greater passion. My wife’s family appears to have genetic disposition to diabetes. One of her 2nd cousins, a T1, died suddenly in her early 20s from “complications”. One of the other cousins has a dad (in his 70s, legally blind, and in deteriorating health) and a pre-teen son who are both T1s. When her diabetic son was quite young they learned he was a T1. She had grown up with a family member managing a T1 lifestyle and it seemed to basically terrify her and she shared that nights were the worst. They’ve managed of course, and both son and dad use pumps (but not CGMs). Interestingly, she is the second person I found who knew of Afrezza before I told them. She was interested in using it for her young son for the reasons you are illuminating. I told her about the pediatric trials, but I’ve not talked with her about management of her son’s diabetes since that time. Once approval for pediatric use is secured, I am going to make sure she knows.
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Post by agedhippie on Jan 8, 2020 12:04:35 GMT -5
I am curious why you think endos are going to start promoting Afrezza by T1s more now and didn't do it last year. I was under the impression, that when physicians see a medication work extremely well for their patients and their patients are happier; is the reason physicians put more of their patients on that medication. That and health insurance coverage. sorry about that run on sentence above. I think you are correct. That begs the question as to why after five years there has not been any serious take up. My feeling is that the case has not been made in a compelling way and the doctors are going with what they view as working. How could it be made more compelling? Run a superiority trial. Without that nothing changes despite what people have been repeatedly saying for years.
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