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Post by zuegirdor on Nov 14, 2016 17:50:21 GMT -5
Good call on the versioning. I think most of the list and narrative is spot on. But I wonder about the long term safety trial. I seem to remember the FDA only soft pedaled the idea. I deally you want to know long term effects before they have a chance to occur. Therefore ( and in the Analyses I read) study design should be based upon an early detection protocol. This would mean enormous (and cost prohibitive?)sample sizes of greater than 50 or 60,000 subjects. This is practically infeasible at the get go. With the background lung cancer rate at 1 per thousand or even less, for I don't know what timescale (lifetime?)the number of years the n=60K study would need to run may also be prohibitively high. But in a way this infeasiblity issue is a good thing. The reason the study may be infeasible is that the rate of lung cancer in the study was so low as to be indistinguishable form background. As to doctors resistance, there is plenty of hypocrisy in where they draw the line in the sand. I personally know doctors that smoke and make other choices that I question. If a type 1 doctor wants Afrezza they are free to self Rx because they "have done their own risk benefit analysis as doctors and type 1 diabetics". Diabetes patients should be given the same choice whether they are doctors or not. As justification I offer the abundance of evidence of the psychological ravages wrought by Type 1 diabetes. When is someone going to do a trial on the liberation and relief from angst that Afrezza provides users? I personally know young diabetics, especially teens transitioning to young adulthood who have been crippled physically and mentally by this diseases. What is the point of worrying about even a modestly elevated incidence of pulmonary effects (not that the data even indicates such)when teen adherence and on-target BG is 10 % and adult figures are at 35%? A huge chunk of that population is going to suffer long before any prospective lung effects manifest? And when I said long term effects for lung problems were infeasible I meant for any Pharma company, not just Mannkind. Think about the impact of dropouts alone on a study of 60,000 subjects for 5 years trying to power a hypothesis that, hypothetically speaking, say 65 cases of lung cancer is significantly different than 60 (assuming 60 per 60,000 is the background level....) The risk of a wasted investment must be HUGE! And its all because the FDA trials, sizable in their own right, did not detect rates above background. Hard to say what this means other than, let DIABETICS do their own risk benefit assessment if you want to learn anything. Doctors should have a say but not be allowed to obstruct!
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Post by peppy on Nov 14, 2016 18:05:13 GMT -5
Unfortunately Peppy from my personal experiencers and in speaking with a couple of people I am and have tried to help get a script it is just that simple for some doctors. Now i do agree with you that eventually digital technology/cgm's will help change the perception of many docs but for a T1 in relatively good control between 6.3 and 7.0 there seems to be very little motivation or reason to assist with the switch to AFREZZA for now. Agreed, mannmade. I have read the guidelines. I know you are correct manmade, allow me to look at what the physicians are really saying. Paraphrasing, the physician needs to set goals that are correct for what the patient can achieve.
Hgb A1c. Interesting medicine has been able to get glycemic control down to a quarterly number. 6.3 to 7.0 I have to look what that means in the numbers I know like the back of my hand. 6.3 equals 134. 7.0 equal 154. (mg/dl)
Alrighty then.
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Post by wgreystone on Nov 14, 2016 18:12:45 GMT -5
"4. Epi Hale Progress towards a early 2018 Product Launch".
This is a little bit shock to me. Any source that this trial could be done so quick?
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Post by Deleted on Nov 14, 2016 18:17:09 GMT -5
"4. Epi Hale Progress towards a early 2018 Product Launch". This is a little bit shock to me. Any source that this trial could be done so quick? it only requires phase 1 and phase 2 trials and was always said , 10 months for both.
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Post by goyocafe on Nov 14, 2016 18:24:06 GMT -5
"4. Epi Hale Progress towards a early 2018 Product Launch". This is a little bit shock to me. Any source that this trial could be done so quick? I thought I heard the IND would be submitted in Dec 2017. That would put an NDA and FDA approval way out, after trials in 2018. I would love to be wrong.
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Post by Deleted on Nov 14, 2016 18:27:03 GMT -5
"4. Epi Hale Progress towards a early 2018 Product Launch". This is a little bit shock to me. Any source that this trial could be done so quick? I thought I heard the IND would be submitted in Dec 2017. That would put an NDA and FDA approval way out, after trials in 2018. I would love to be wrong. timeline could have changed , but this is from 01/16.
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Post by cjc04 on Nov 14, 2016 19:13:18 GMT -5
Unfortunately Peppy from my personal experiencers and in speaking with a couple of people I am and have tried to help get a script it is just that simple for some doctors. Now i do agree with you that eventually digital technology/cgm's will help change the perception of many docs but for a T1 in relatively good control between 6.3 and 7.0 there seems to be very little motivation or reason to assist with the switch to AFREZZA for now. Mannmade, I think you're exactly right, and THAT is the biggest problem. My wife, T1 with a 6.5 a1c, was told by multiple endos that she was fine, 6.5 is great.... however, she was up in the middle of the night 3 to 5 times week with low bs. SO, if you're having so many lows, and your a1c is a "great" 6.5, then what kind of highs must you be having to average it out? ? Sure enough, when she went on a trial CGM for two weeks, she was hitting numbers in the 400's.... So,,,, super highs and super lows gets you a "great" a1c number, and endos are happy. Ridiculous! btw,,,,, 5.7 a1c after 3 months on Afrezza.
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Post by goyocafe on Nov 14, 2016 19:18:55 GMT -5
I thought I heard the IND would be submitted in Dec 2017. That would put an NDA and FDA approval way out, after trials in 2018. I would love to be wrong. timeline could have changed , but this is from 01/16. I went back and looked at the slides from last week, and they certainly look a little different than during the presentation. Very happy to stand corrected!
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Post by mannmade on Nov 14, 2016 19:20:35 GMT -5
Unfortunately Peppy from my personal experiencers and in speaking with a couple of people I am and have tried to help get a script it is just that simple for some doctors. Now i do agree with you that eventually digital technology/cgm's will help change the perception of many docs but for a T1 in relatively good control between 6.3 and 7.0 there seems to be very little motivation or reason to assist with the switch to AFREZZA for now. Mannmade, I think you're exactly right, and THAT is the biggest problem. My wife, T1 with a 6.5 a1c, was told by multiple endos that she was fine, 6.5 is great.... however, she was up in the middle of the night 3 to 5 times week with low bs. SO, if you're having so many lows, and your a1c is a "great" 6.5, then what kind of highs must you be having to average it out? ? Sure enough, when she went on a trial CGM for two weeks, she was hitting numbers in the 400's.... So,,,, super highs and super lows gets you a "great" a1c number, and endos are happy. Ridiculous! btw,,,,, 5.7 a1c after 3 months on Afrezza. cj a perfect summary of what seems to be the issue. Digital technology as you point out will help but it will all take time...
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Post by bill on Nov 14, 2016 20:07:49 GMT -5
Based on the last conference call I am looking at the date of 11.09.16 as the start of MannKind 2.1, which is for me, the logical update to MannKind 2.0 which was started when Sanofi returned the rights to AFREZZA back to MannKind on April 4th or so. I think by now everyone knows the main points of what made the last conference call so positive. So now what do I/we have to look forward to with MannKind 2.1 in the next 3 months (really the 4th Q 2016 CC)? I am listing (my opinion only) what I think are the reasonable possibilities for near term events that should allow for the continuation of the upward movement of the share price... Now that Mnkd has a runway into 3rd Q of 2017, short term money is not an issue and that "Money Elephant" has temporarily left the room leaving only its twin of weekly low scripts growth/counts. So with the money elephant gone for now, we should expect to see the following by year's end... 1. Steady (but slow) script growth, perhaps 400 to 500 per week by year's end. (Note there will be plenty of holiday, 3 and 4 day week excuses to go around regarding slower than expected script growth...) 2. A very modest RLS payment of say $10M, which will prove they are real and that the deal is verifiable as a potential revenue stream down the road. We may not learn much more about them, but the actual payment should be a confidence builder regarding MannKind technology and alternative revenue streams. I believe the two items above will help us get the price back over $1.00 pps. Additionally, for the longer term within the next twelve months we can look forward to the following: 1. Start and Conclusion of Pediatric Study 2. Beginning of JDRF/Mnkd Long Term Safety Study plus other studies as indicated by Ray Urbanski 3. More Robust DTC Campaign 4. Epi Hale Progress towards a early 2018 Product Launch 5. Continued Script Growth to perhaps 1,000 to 2,000 per week by year end 2017. (I have greatly reduced my expectations for the path of script growth as I have learned just how much disbelief there is in the medical community regarding the anecdotal evidence of how good AFREZZA really is as compared to the label and allowed FDA information/communication about AFREZZA.)6. Label Change 7. International opportunity 8. Partnership 9. Additional funds from warrants kicking in at $1.50 10. Hiring of Senior Reps as MannKind EE's* 11. Television Commercials* (*Now with regard to the asterisks, I am not sure if the funds for those items are part of the current calculation for runway extension until 3rd Q 2017 or not. If no,t then they must have a plan for additional funds which to me would also be a positive. And if they are already budgeted for then even better...) What I see is that with the beginning of MannKind 2.1 there is a very targeted and methodical approach to supporting and growing AFREZZA's market share. This is vey important because as I have learned from my own personal experiences the resistance to change in the medical community is huge here, so it is going to take time, more time than I ever imagined for a drug that is so good... From what I now personally know having spoken with many Endos and doctors, that in addition to the above, MannKind will have to get more opportunistic and try to engage the voice of a few "Alpha Endos" and thought leaders to get them to publish positive articles so that the rest of the pack will follow. To me this will be one of the key ingredients to moving the needle. While patient awareness and DTC are necessary to improve overall awareness and demand, without Endo/Medical understanding & acceptance of AFREZZA, we will not succeed. As imho, no matter how many patients demand AFREZZA, if their doctor says no most will listen to their doctor and very few will take the time and energy to fight with their doctor or switch to another doctor to get it. With the other issues of Spirometry, Insurance, etc being resolved by MannKind the above, to me, remains the most critical and number one priority to overcome in an effort to make AFREZZA the overwhelming success it should be... But I do personally believe MannKind is on the right path... I have been shocked by the physicians. The continuous glucose monitors are absolute proof of smooth post meal glucose control provided by afrezza. The proof does not get more in our face obvious. Physicians can see. Any physician can read 10 glucose monitor print outs in a minute. Instant, concise, objective patient data. Interesting gig. Patients with continuous glucose monitors may need to embarrass the physician with copies of other peoples anecdotal real time data, for in your face, press the issue. Patient to physician, "I want what these people have." and give the physician the print out of 5 peoples continuous glucose monitor read outs. What is the physician going to say? That we are not blind, that we can see with cgm's are what is going to save us. Ha, we had to fight for the right.
peppy You may have just hit on a wonderful Afrezza marketing idea. Wouldn't it be cool if one of the Afrezza advocates would stand up a web site where PWDs can post their pictures, some comments, their twitter handle, and a CGM printout into an "Afrezza CGM Wall." As time went on the wall's entries would grow and grow, and patients could simply refer their physicians to the wall's URI with a "I want that!" comment. Tens, hundreds, and eventually thousands of posters couldn't all be wrong . Such a site couldn't be sponsored by MNKD, but I doubt there'd be any prohibition against a non-affiliated entity doing it. Just an idea...
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Post by peppy on Nov 14, 2016 20:22:35 GMT -5
I have been shocked by the physicians. The continuous glucose monitors are absolute proof of smooth post meal glucose control provided by afrezza. The proof does not get more in our face obvious. Physicians can see. Any physician can read 10 glucose monitor print outs in a minute. Instant, concise, objective patient data. Interesting gig. Patients with continuous glucose monitors may need to embarrass the physician with copies of other peoples anecdotal real time data, for in your face, press the issue. Patient to physician, "I want what these people have." and give the physician the print out of 5 peoples continuous glucose monitor read outs. What is the physician going to say? That we are not blind, that we can see with cgm's are what is going to save us. Ha, we had to fight for the right.
peppy You may have just hit on a wonderful Afrezza marketing idea. Wouldn't it be cool if one of the Afrezza advocates would stand up a web site where PWDs can post their pictures, some comments, their twitter handle, and a CGM printout into an "Afrezza CGM Wall." As time went on the wall's entries would grow and grow, and patients could simply refer their physicians to the wall's URI with a "I want that!" comment. Tens, hundreds, and eventually thousands of posters couldn't all be wrong . Such a site couldn't be sponsored by MNKD, but I doubt there'd be any prohibition against a non-affiliated entity doing it. Just an idea... That is a good idea. Perhaps on afrezza, just breathe, a cgm wall.
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Post by sweedee79 on Nov 14, 2016 20:35:21 GMT -5
Peppy, simply not that simple I hate to say as you would rightly think it should be. However many doctors still think there may be long term lung issues among other things... I still don't understand why docs worry about this.... I don't see how docs could be held responsible for any long term effects of Afrezza if there were any .. Wouldn't MNKD be held responsible?? If they are worried about their "do no harm" oath .. they already prescribe meds with well known side effects and prescribe them anyway because the benefits outweigh possible side effects .. What about damage caused by slower insulins that hang in the bloodstream which then cause weight gain and complicates diabetes further, the risk of hypos... higher A1Cs which causes damage to the body.. not to mention the psychological effects of having diabetes.. diabetic burnout... reduced quality of life and depression ... I think that if docs don't want to prescribe becuz they worry about long term issues with lungs etc.. they are doing a disservice to their patients...and almost sounds like an excuse, so they don't have to change the status quo.. its sad to me that they are doing this... but I guess it is what it is ..
But I do believe due to personal experience that the more you contradict a doc or question them about their choice of treatment .. they will dig in and refuse to change all the more.. this has been my experience.. there is a lot of pressure in this particular profession to know everything and always be right... and if you mess up you get blamed... so in that respect I guess I do understand ..
Regarding patients and their relationships with their docs... yes, I do believe that MOST patients are somewhat robotic when they go the doc and tend to listen to and do whatever the doc tells them to do.... I know I used to be that way until my eyes were opened as was my dads .. Its amazing to me how much he doesn't understand his own disease because the medical profession doesn't do much to educate patients.. or the patients simply take no time to understand it themselves. So while I still believe this will be patient driven, I do think we will be in a better more receptive position if the endos are educated about Afrezza and more willing to prescribe..
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Post by Deleted on Nov 14, 2016 20:51:50 GMT -5
Mannmade, I think you're exactly right, and THAT is the biggest problem. My wife, T1 with a 6.5 a1c, was told by multiple endos that she was fine, 6.5 is great.... however, she was up in the middle of the night 3 to 5 times week with low bs. SO, if you're having so many lows, and your a1c is a "great" 6.5, then what kind of highs must you be having to average it out? ? Sure enough, when she went on a trial CGM for two weeks, she was hitting numbers in the 400's.... So,,,, super highs and super lows gets you a "great" a1c number, and endos are happy. Ridiculous! btw,,,,, 5.7 a1c after 3 months on Afrezza. What does your doc say now? Did you tell him about the results and high and lows and averaging out and hypos in the night?
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Post by dreamboatcruise on Nov 14, 2016 20:55:54 GMT -5
"4. Epi Hale Progress towards a early 2018 Product Launch". This is a little bit shock to me. Any source that this trial could be done so quick? I thought I heard the IND would be submitted in Dec 2017. That would put an NDA and FDA approval way out, after trials in 2018. I would love to be wrong. In one of the presentations they explained that Epihale would be much quicker approval process since you can't have a Phase 3 trial where you cause potentially severe allergic reactions. So the efficacy part I think is assumed given it is a known API. That cuts the trials down to the safety ones. At least that is what I remember.
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Post by audiomr on Nov 14, 2016 21:13:53 GMT -5
"4. Epi Hale Progress towards a early 2018 Product Launch". This is a little bit shock to me. Any source that this trial could be done so quick? I believe Ray said, a couple of CCs ago, that they only had to show bio-equivalency. That's why they fast-tracked epi -- don't have to run the whole gauntlet.
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