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Post by rockstarrick on Mar 30, 2016 18:59:59 GMT -5
I'm not sure how to go about getting this idea from the depths of my very shallow brain to this thread, but I will do my best, (I may need assistance, so feel free to chime in).
Since February 3rd 2015, Physicians have been writing scripts for Afrezza, not the volume we would like or expect to see, but week after week Afrezza has been offered by a Physician, to a PWD as an alternate to other Prandial insulin products.
If I were that Physician that just changed one of my patients from a current therapy, (such as insulin), to an inhaled form of a brand new type of insulin, I would definetly increase the monitoring schedule of that patient to ensure this new option was performing as good or better than the prior insulin.
Since February of 2015, Afrezza and the performance of Afrezza has been adjudicated by at least every Physician that has prescribed it, by every PWD that has tried it, and most likely by any Pharmaceutical Company that sells products that treat T1 and T2 Diabetes.
We have seen the flat line trends posted by PWD, we have read the testimonials of these people praising Afrezza, we are consistantly seeing lifetime best A1c's at or near non diabetic numbers, (if not better), not to mention other reports of normal liver function tests, improved blood pressure and cholesterol, retinopathy improvements, insulin resistance reversal, and overall better quality of life, (fewer injections).
So here's my point.
If you were any of the above mentioned people, (PWD, Physician, or BP that treats diabetes), and saw with your own eyes how incredible Afrezza really is. Would you just sit and watch this amazing new insulin option fail, or would you find a way to be a part of the effort to ensure the success of Afrezza ??
I'm just wondering what investors think. Will the performance of Afrezza, (that has been closely monitored) be swept under the rug, or be the reason Afrezza lives on to be the Blockbuster that Al Mann always knew it would be.
As for me, I believe the last year has more than sealed the success of Afrezza, what does everybody else think.
Thanks
Good Luck Longs
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Post by yash on Mar 30, 2016 20:29:03 GMT -5
Agree with you rick.
And keeping above in mind and considering the existing satisfied patients the scripts number should have remained same or increased slowly.
My concern is why the script numbers have gone down.
May be I am missing some other logical reason.
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Post by nylefty on Mar 30, 2016 21:02:06 GMT -5
Agree with you rick. And keeping above in mind and considering the existing satisfied patients the scripts number should have remained same or increased slowly. My concern is why the script numbers have gone down. May be I am missing some other logical reason. Actually, new scripts are being written every week, just not as many new scripts as before Sanofi filed for divorce. I suspect that some doctors and some diabetics think that Afrezza may no longer be available if MannKind goes out of business and don't want to start a new med if it's going to be taken off the market. I don't believe that will happen, but the shorts and other bashers are saying otherwise. I keep coming back to the fact that Al Mann told the New York Times nine years ago that his will instructed his foundation to make sure that his companies had "enough money." I can't imagine why he would have changed his mind, especially since he said he was leaving nothing to his children, all of whom he said were multi-millionaires and didn't need any more of his money. |
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Post by mnkdfann on Mar 30, 2016 22:30:08 GMT -5
I keep coming back to the fact that Al Mann told the New York Times nine years ago that his will instructed his foundation to make sure that his companies had "enough money." I can't imagine why he would have changed his mind, ... Even if Al did not change his mind over nine years, it is fair to say that circumstances certainly did. I don't know whether he left as much to his foundation as he once intended to, or whether what he thought would be sufficient nine years ago would still suffice today. None of us know, only time will tell. |
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Post by rockstarrick on Mar 31, 2016 0:40:45 GMT -5
I guess what I'm asking, is regardless of what script counts were, (yash), and to know for a fact that Afrezza wasn't going to be taken off the market, (nylefty), and regardless of Al's will, or even wealth for that matter, (mnkdfan), how could Afrezza possibly fail given the amazing results seen by Physicians, Patients, and BP Companies that treat Diabetes ??
In my opinion, the odds of Afrezza failing are slim to none.
I talked to a Physician today, (my new PCP) that has been prescribing Afrezza for over a year now, he feels the same. He said once you get by the hassle of actually getting a patient on Afrezza, everything else just seemed to fall in place. He said all his patients loved it, and that not only their A1c's, but their over all health was better since switching to Afrezza. These are patients that he has not only treated for years, but due to Diabetes, has paid special attention to their overall health. He claims there is a noticeable difference, especially the patients that were having the most difficulty controlling their Diabetes. He believes Afrezza is here to stay.
It was really refreshing, (for lack of a better word), to hear from a Physician that I just met yesterday, how good Afrezza really is.
I believe once the process of actually getting Afrezza is easier, and the price and insurance coverage Improves, Afrezza will be as successful as any other mealtime insulin option.
I also believe that the VDEX Clinics are going to be a huge success if given the chance.
I Just wanted to share this.
Good Luck Longs
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Post by babaoriley on Mar 31, 2016 1:07:15 GMT -5
"In my opinion, the odds of Afrezza failing are slim to none."
You think like several others, rick, and certainly that's not bad. On the other hand, if you had asked me at the beginning of 2015 the odds of us being in this position at this time, my answer would have been the same as your current opinion.
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Post by rockstarrick on Mar 31, 2016 2:32:39 GMT -5
After talking with that Physician today, I feel pretty good about my decision to invest in Mannkind and Afrezza. I know there is risk, but I feel Afrezza will get its share of the market.
I sure hope I'm right.
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Post by ezrasfund on Mar 31, 2016 9:05:26 GMT -5
Just a reminder that we do not live in the best of all possible worlds and good does not always prevail over evil. I keep in mind several examples of medical treatments that have been ignored by physicians and could improve health or save thousands of lives, but are not accepted or widely used. Read this article about the history of breakthrough cancer treatments that were received by physicians as "no big deal" or modified on their whim so that they were ineffective. www.newyorker.com/wp-content/uploads/2015/12/151214_r27432-864.jpgI have had pretty serious gum disease for many years. I finally got it under control with a hydrogen peroxide rinse. The dentist, hygienists and periodontist all remark on how much better my gums are, but are not really interested in why. When I ask/tell them about hydrogen peroxide they all have the same disinterested response which includes how dangerous it can be in high concentrations (which are virtually unavailable to the consumer, who only knows the common 3% solution). Fecal transplants for patients suffering from clostridium-difficile (C. diff) could save thousands from death each year and tens of thousands from a lifetime of suffering. A recent trial of its effectiveness was halted...you know, virtually all the patients were cured so it would be immoral not to offer it to the other arm of the trial. But who is going to spend hundreds of millions of dollars to develop a "uniform, active ingredients only" treatment that the FDA might approve which could easily be copied? These treatments really present similar hurdles to regulating blood transfusions. And as an added bonus, fecal transplants are only offered as a last resort treatment after everything else has been tried, including every antibiotic on the shelf. Or you could look at the obesity epidemic. Is it really just a crisis of willpower where people can't stop overeating? I think not. How was the medical community so sure Atkins was a quack when all he was advocating was what was considered common sense in the early 20th century? One thing some of these examples have in common is that the inferior treatments work, if the patients would only comply with doctors orders. If you just restrict your diet to <1500 healthy calories/day and get plenty of exercise you could loose weight. If you just brushed and flossed your way to perfect dental hygiene there would be no gum disease. And we all know that current diabetes treatments work and can keep even Type 1 diabetics alive indefinitely, if they follow all of the protocols exactly. Which is all to say that Al Mann was right about Afrezza being a vastly superior form of insulin therapy, but that doesn't mean doctors will prescribe it. The best way to do no harm is to "just not do it" (with apologies to Nike). |
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Post by mindovermatter on Mar 31, 2016 9:21:17 GMT -5
Just a reminder that we do not live in the best of all possible worlds and good does not always prevail over evil. I keep in mind several examples of medical treatments that have been ignored by physicians and could improve health or save thousands of lives, but are not accepted or widely used. Read this article about the history of breakthrough cancer treatments that were received by physicians as "no big deal" or modified on their whim so that they were ineffective. www.newyorker.com/wp-content/uploads/2015/12/151214_r27432-864.jpgI have had pretty serious gum disease for many years. I finally got it under control with a hydrogen peroxide rinse. The dentist, hygienists and periodontist all remark on how much better my gums are, but are not really interested in why. When I ask/tell them about hydrogen peroxide they all have the same disinterested response which includes how dangerous it can be in high concentrations (which are virtually unavailable to the consumer, who only knows the common 3% solution). Fecal transplants for patients suffering from clostridium-difficile (C. diff) could save thousands from death each year and tens of thousands from a lifetime of suffering. A recent trial of its effectiveness was halted...you know, virtually all the patients were cured so it would be immoral not to offer it to the other arm of the trial. But who is going to spend hundreds of millions of dollars to develop a "uniform, active ingredients only" treatment that the FDA might approve which could easily be copied? These treatments really present similar hurdles to regulating blood transfusions. And as an added bonus, fecal transplants are only offered as a last resort treatment after everything else has been tried, including every antibiotic on the shelf. Or you could look at the obesity epidemic. Is it really just a crisis of willpower where people can't stop overeating? I think not. How was the medical community so sure Atkins was a quack when all he was advocating was what was considered common sense in the early 20th century? One thing some these examples have in common is that the inferior treatments work, if the patients would only comply with doctors orders. If you just restrict your diet to <1500 healthy calories/day and get plenty of exercise you could loose weight. If you just brushed and flossed your way to perfect dental hygiene there would be no gum disease. And we all know that current diabetes treatments work and can keep even Type 1 diabetics alive indefinitely, if they just follow all of the protocols exactly. Which is all just to say that Al Mann was right about Afrezza being a vastly superior form of insulin therapy, but that doesn't mean doctors will prescribe it. The best way to do no harm is to "just not do it" (with apologies to Nike). And junk science has done much to make people ill. Just look at the "fat is bad" crusade. |
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Post by sweedee79 on Mar 31, 2016 10:38:56 GMT -5
After being on Afrezza for 5 month... my dad was forced to go back to Novolog in January for insurance reasons and lack of support. Since then he has gained all of his 24lbs back he had lost while on Afrezza. He consistently complains that he doesn't feel good anymore since going back to Novolog. He recently saw his internal medicine doctor and asked if there was any other new medicine he could go on because he hated Novolog. The doctor told him no.. they are all too expensive and insurance doesn't cover them. He told my dad to wait until the prices come down and there is better insurance coverage.
Afrezza in itself is a success, the marketing side of it was a failure on SNY's part. Some of what we have seen is normal for the new release of an expensive drug. However, our FDA restrictions are very challenging and Afrezza should have been priced appropriately considering the situation.
I don't know how MNKD plans to overcome the obstacles in the US beyond lowering the price. IMO a label change is very important to the rapid marketing success of Afrezza. Without a label change it will take longer for Afrezza to gain blockbuster status since we are unable to make the claims we need to make such as, Afrezza induces weight loss, very reduced risk of hypo and the ability to achieve lower A1Cs when prescribed properly. Afrezza is more than just a new drug... it also represents a new standard of care that veers from what docs are used to. It is not the same dose for dose as injectable. If we cant educate docs properly due to FDA restrictions it makes the task very difficult. We wouldl have to rely on word of mouth to get this job done, or perhaps a paper written in a journal and there is the possibility of marketing in another country.
Whether or not Afrezza achieves blockbuster status depends on MNKD getting the financing and support they need... a partner, or sale of the company etc. I personally don't want them to sell Afrezza to anyone... MNKD started this and I want them to finish it. I believe Matt is dedicated to getting this done and was and is dedicated to Al Mann's vision.
If the medical profession and patients don't understand Afrezza, it makes its sales success very very challenging, but I am confident that MNKD is aware of the challenges they face. Its hard for me to believe that something so amazing will fall into the cracks so easily. Considering MNKD has held on all of these years I think they can hang on a bit longer. With the introduction of the RLS agreement and MNKDs association with VDEX, it shows they have financial connections and people who support the technology. However nerve racking this investment has been, I am in it for the long haul... and doubled my investment at .90, but we all have to agree this is a speculative investment which has also become personal for me. It makes me angry that something which could help people with diabetes so much has had so many obstacles thrown in its way and this has also opened my eyes to the way the entire medical industry works in the US from big pharma, insurance, FDA and also to the clinics and doctors we all rely on.
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Post by peppy on Mar 31, 2016 11:26:32 GMT -5
After being on Afrezza for 5 month... my dad was forced to go back to Novolog in January for insurance reasons and lack of support. Since then he has gained all of his 24lbs back he had lost while on Afrezza. He consistently complains that he doesn't feel good anymore since going back to Novolog. He recently saw his internal medicine doctor and asked if there was any other new medicine he could go on because he hated Novolog. The doctor told him no.. they are all too expensive and insurance doesn't cover them. He told my dad to wait until the prices come down and there is better insurance coverage.
Afrezza in itself is a success, the marketing side of it was a failure on SNY's part. Some of what we have seen is normal for the new release of an expensive drug. However, our FDA restrictions are very challenging and Afrezza should have been priced appropriately considering the situation.
I don't know how MNKD plans to overcome the obstacles in the US beyond lowering the price. IMO a label change is very important to the rapid marketing success of Afrezza. Without a label change it will take longer for Afrezza to gain blockbuster status since we are unable to make the claims we need to make such as, Afrezza induces weight loss, very reduced risk of hypo and the ability to achieve lower A1Cs when prescribed properly. Afrezza is more than just a new drug... it also represents a new standard of care that veers from what docs are used to. It is not the same dose for dose as injectable. If we cant educate docs properly due to FDA restrictions it makes the task very difficult. We wouldl have to rely on word of mouth to get this job done, or perhaps a paper written in a journal and there is the possibility of marketing in another country.
Whether or not Afrezza achieves blockbuster status depends on MNKD getting the financing and support they need... a partner, or sale of the company etc. I personally don't want them to sell Afrezza to anyone... MNKD started this and I want them to finish it. I believe Matt is dedicated to getting this done and was and is dedicated to Al Mann's vision.
If the medical profession and patients don't understand Afrezza, it makes its sales success very very challenging, but I am confident that MNKD is aware of the challenges they face. Its hard for me to believe that something so amazing will fall into the cracks so easily. Considering MNKD has held on all of these years I think they can hang on a bit longer. With the introduction of the RLS agreement and MNKDs association with VDEX, it shows they have financial connections and people who support the technology. However nerve racking this investment has been, I am in it for the long haul... and doubled my investment at .90, but we all have to agree this is a speculative investment which has also become personal for me. It makes me angry that something which could help people with diabetes so much has had so many obstacles thrown in its way and this has also opened my eyes to the way the entire medical industry works in the US from big pharma, insurance, FDA and also to the clinics and doctors we all rely on.
Thank you for telling us. |
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Post by longinvstr on Mar 31, 2016 11:48:05 GMT -5
After being on Afrezza for 5 month... my dad was forced to go back to Novolog in January for insurance reasons and lack of support. Since then he has gained all of his 24lbs back he had lost while on Afrezza. He consistently complains that he doesn't feel good anymore since going back to Novolog. He recently saw his internal medicine doctor and asked if there was any other new medicine he could go on because he hated Novolog. The doctor told him no.. they are all too expensive and insurance doesn't cover them. He told my dad to wait until the prices come down and there is better insurance coverage.
Afrezza in itself is a success, the marketing side of it was a failure on SNY's part. Some of what we have seen is normal for the new release of an expensive drug. However, our FDA restrictions are very challenging and Afrezza should have been priced appropriately considering the situation.
I don't know how MNKD plans to overcome the obstacles in the US beyond lowering the price. IMO a label change is very important to the rapid marketing success of Afrezza. Without a label change it will take longer for Afrezza to gain blockbuster status since we are unable to make the claims we need to make such as, Afrezza induces weight loss, very reduced risk of hypo and the ability to achieve lower A1Cs when prescribed properly. Afrezza is more than just a new drug... it also represents a new standard of care that veers from what docs are used to. It is not the same dose for dose as injectable. If we cant educate docs properly due to FDA restrictions it makes the task very difficult. We wouldl have to rely on word of mouth to get this job done, or perhaps a paper written in a journal and there is the possibility of marketing in another country.
Whether or not Afrezza achieves blockbuster status depends on MNKD getting the financing and support they need... a partner, or sale of the company etc. I personally don't want them to sell Afrezza to anyone... MNKD started this and I want them to finish it. I believe Matt is dedicated to getting this done and was and is dedicated to Al Mann's vision.
If the medical profession and patients don't understand Afrezza, it makes its sales success very very challenging, but I am confident that MNKD is aware of the challenges they face. Its hard for me to believe that something so amazing will fall into the cracks so easily. Considering MNKD has held on all of these years I think they can hang on a bit longer. With the introduction of the RLS agreement and MNKDs association with VDEX, it shows they have financial connections and people who support the technology. However nerve racking this investment has been, I am in it for the long haul... and doubled my investment at .90, but we all have to agree this is a speculative investment which has also become personal for me. It makes me angry that something which could help people with diabetes so much has had so many obstacles thrown in its way and this has also opened my eyes to the way the entire medical industry works in the US from big pharma, insurance, FDA and also to the clinics and doctors we all rely on.
I believe the 2nd quarter begins the process of fixing many things: pricing, insurance coverage, access to/support for Afrezza, getting that weight back off your Dad, have him feeling better again and, most importantly, we'll get your frown inversed. |
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Post by BlueCat on Mar 31, 2016 11:54:15 GMT -5
I just tried to reply to the "Nice News" thread just as it locked. So my crafted response went to bit bucket. But I think the reply applies here as well.
Mind over Matter had made a statement that MNKD mgt had little proof/success in execution. Without bashing the poster, I dissent with that opinion, which is in large part due to Afrezza itself.
Here are the key points I think MNKD mgt has demonstrated success in execution:
1. Developing, getting FDA approval and bringing to market Afrezza - a revolutionary treatment with demonstrated happy patients and good results - despite efforts by panels and Shrek to block.
2. Development of TS - and now a licensing deal with RLS that in future may be revenue-bearing
3. A library of patents
4. The securing of a market leading Diabetes partner for GTM (tho that turned out no so good in end)
5. They met and exceeded their contractual obligations as the mfg to that contract
6. They worked with GTM partner to execute and/or initiate the FDA required trials
7. They managed to contain dilution while still extending their runway (e.g. TASE)
9. They have survived major business changes that all occurred within <6mos - Partner CEO change and scandals, their own 2x CEO change, their Founder/Main Investors passing, and now, the ending of their main GTM partner contract
That's a lot of actual, successful execution.
Now - where does the question come up? The successful, full GTM launch of Afrezza to get the drug into the hands of its market potential. And this will resolve the two areas where they have not - yet - executed. Meeting full expectation of Afrezza GTM potential, and investor stock price.
But - at one year in - this game is not yet done. Behind schedule. But should not be graded as "failure".
I'm for balanced view. But let's make it balanced and fair. Saying MNKD mgt has mostly failed across the board is not fair, IMHO, and especially in light of the drug itself. That has been clearly demonstrated as a resounding success, and hopefully the results to be shared this summer will substantiate this further.
My .02
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Post by mindovermatter on Mar 31, 2016 11:58:56 GMT -5
Q2U, thanks for a rational response instead of a personal and emotional attack.
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Post by sccrbrg on Mar 31, 2016 12:40:03 GMT -5
I'm for balanced view. But let's make it balanced and fair. Saying MNKD mgt has mostly failed across the board is not fair, IMHO, and especially in light of the drug itself. That has been clearly demonstrated as a resounding success, and hopefully the results to be shared this summer will substantiate this further.
My .02 Just a hunch, but I don't think the results shared at that conference are going to be the fabled "Superiority" results that we are all hoping for - and if it is, I would very seriously question management's intellect. If they are sitting on bombshell information, the correct thing to do would be to announce it as soon as possible and start working on a label change and insurance coverage. They would have to be completely inept to sit on that information for months in a precarious cash position just for the sake of unveiling it at a conference. Heck, they could release it the day the rights transfer back to MNKD and re-discuss it at the conference and have the same effect. For these reasons, I think that all we are going to see is a substantiation of the current non-inferior label, which is a bummer. |
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