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Post by factspls88 on Dec 16, 2015 13:28:59 GMT -5
It's a dessert topping and a floor wax. Afrezza is different and superior. Honestly I don't think it's necessary to go through a litany of reasons why. We know why it's different (inhaled, human insulin) , and we have seen superior results by users because it mimics the human pancreas better than any other prandial insulin on the market. In addition, insulin delivery can be fine-tuned if necessary allowing the user to eat more like those of us without diabetes . You can't do that with an injectable insulin analog. www.hulu.com/watch/264564 |
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Post by sweedee79 on Dec 16, 2015 13:54:07 GMT -5
Here's my take: Afrezza IS different and IS superior to anything out there when used the correct way it was meant to be used. Lower A1c's, lower FBG, better overall labs, person feels better overall, potential to drop other meds being used, etc. We've seen all of these things happen more than once. JMHO. I agree with you.. Afrezza is superior... I have seen it first hand... When my dad was on Afrezza he felt much better.. more energy... lost weight(24lbs).. his blood pressure readings were better.. he ended up having to discontinue use because the docs didn't really know what they were doing or how to dose and didn't seem interested in learning either.. and then the insurance company stopped paying for it .. He told me that as soon as Afrezza was more established he would go back to it right away. .. His dose was too low and docs refused to raise it. They were trying to dose him the same as they would injectable.. My dad needed docs and insurance that he could depend on and were supportive..
Afrezza is in fact also DIFFERENT ..in the instruction sheet that comes with the prescription it says Afrezza is the same dose for dose as injectable.. NOT TRUE .. but I think the non-inferior label forces them to state this because this is how the trials were run for the FDA.... SO YES.. The label is important.. How can we properly educate doctors when the label and instruction sheet isn't even correct? ?
Afrezza IS SUPERIOR!!!!! It is more than "just insulin" ... It is incredibly more natural... in chemistry and also compared with natural insulin release. Its not a cure... but the closest thing to it with proper instruction and use..... IMO it will just be a shame if the medical profession and patients are never given the opportunity to know this.. especially after Al Mann and MNKD worked so hard all of these years bringing this to market...
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Post by mssciguy on Dec 16, 2015 14:04:32 GMT -5
Here's my take: Afrezza IS different and IS superior to anything out there when used the correct way it was meant to be used. Lower A1c's, lower FBG, better overall labs, person feels better overall, potential to drop other meds being used, etc. We've seen all of these things happen more than once. JMHO. I agree with you.. Afrezza is superior... I have seen it first hand... When my dad was on Afrezza he felt much better.. more energy... lost weight(24lbs).. his blood pressure readings were better.. he ended up having to discontinue use because the docs didn't really know what they were doing or how to dose and didn't seem interested in learning either.. and then the insurance company stopped paying for it .. He told me that as soon as Afrezza was more established he would go back to it right away. .. His dose was too low and docs refused to raise it. They were trying to dose him the same as they would injectable.. My dad needed docs and insurance that he could depend on and were supportive..
Afrezza is in fact also DIFFERENT ..in the instruction sheet that comes with the prescription it says Afrezza is the same dose for dose as injectable.. NOT TRUE .. but I think the non-inferior label forces them to state this because this is how the trials were run for the FDA.... SO YES.. The label is important.. How can we properly educate doctors when the label and instruction sheet isn't even correct??
Afrezza IS SUPERIOR!!!!! It is more than "just insulin" ... It is incredibly more natural... in chemistry and also compared with natural insulin release. Its not a cure... but the closest thing to it with proper instruction and use..... IMO it will just be a shame if the medical profession and patients are never given the opportunity to know this.. especially after Al Mann and MNKD worked so hard all of these years bringing this to market...
maybe your testimonial could be reported to the official Afrezza hub and/or the afrezzajustbreathe.com website (compound26 administers that). In the absence of any aggressive SNY advertising, good to get the word out, share the wealth |
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Post by edvarney on Dec 16, 2015 14:23:56 GMT -5
Yes, Thank you Harry!!! Lets face it, users will now say this is the new Paradigm in treating diabetes for mealtimes. Its as close as you can get to having a healthy Pancrease!!! Not to mention its giving your Pancrease a chance to heal over time..
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Post by edvarney on Dec 16, 2015 14:31:57 GMT -5
Hey Sweedie, Congrats. to you and your Dad for your involvement with Afrezza. I believe your experiences are critically important going forward. I would encourage you to directly connect with dr. Bode and or Afrezzauser on this point over the label. These are the kinks that all must be reassessed going forward for success. I believe Afrezza is turning the corner now and Sanofi needs all the feedback they can get for a successful labeling and usage recommendations for Afrezza. I pray you Dad sticks to it and continues the proving you all ready understand w/the new PARADIGM for prandial treatment of diabetes.. God Bless.
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Post by daduke38 on Dec 16, 2015 14:56:52 GMT -5
I've begun to wonder whether trying to get a superiority designation for Afrezza may be expensive, time-consuming, and perhaps unnecessary. After all, Afrezza is just insulin like many other prandial products. The FDA trials didn't show superiority, thus the non-inferior designation. In some ways, that's correct. Afrezza by itself isn't superior. It's different, but different in many important aspects. Let's put aside the inhaled versus injectable differences, but instead focus on the fact that when used optimally, one can avoid blood glucose spikes and run less risk of hypoglycemia--as evidenced by flat-line CGM readings and no hypos. If you dose optimally, you'll probably find that your HbA1c values also decrease. You can even take supplementary doses after meals to suppress blood glucose levels after a large, long-lasting meal without inducing hypoglycemia because Afrezza acts quickly and dissipates quickly. That's another difference. My thought is that it's all about the optimal dosing and timing that makes Afrezza different, and a great product. My marketing tag line would be something like: "Afrezza, it's a different way to treat your Diabetes." Had the FDA trial been designed correctly, it would show superiority. |
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Post by trondisc on Dec 16, 2015 20:43:07 GMT -5
I didn't want to create a new thread topic so I would rather post this here. Can I gather/get a large consensus on the opinion of competitors(i.e. recent Novo Nordisk developments) forcing the hand of Sanofi? Will this really turn out to be the case or could MannKind seek refuge should a partner offer a better profit sharing deal? Sanofi hasn't exactly sheltered MannKind from criticism and only started to get these local TV interview spots the last few months. Pathetic to say even though I'm a long shareholder.
Let's assume for the moment that Afrezza is superior for Type 1 especially (Type 2's use?). We may know it; the real world-use confirms it. If Sanofi "truly believed" they have a game changer on their hands, why wouldn't they put Afrezza at the top of their "parade this name around the company" list?
I'm only in this trade to help people with diabetics/other ailments. Or longer-term...future MannKind inhalable data analytical~wireless monitoring devices that are cloud linked with doctors/hospitals? The PPS sucks but in a strange and twisted way, if I make my money back...the REAL victory is for the patients. I mean this (even though I'm very sad I just cost myself more than I'm willing to admit the last few months).
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Post by sluggobear on Dec 17, 2015 3:46:14 GMT -5
To reply to Bill's original comment: " I believe we all agree that you CAN get superior results if you use Afrezza optimally. I suspect we can also agree that you may not get superior results if you don't. What's different (and superior) about Afrezza is that you have the ability to get superior results, i.e., Afrezza by itself isn't superior, it's the fact you can use it in ways that get you superior results." Read more: mnkd.proboards.com/thread/4522/afrezza-different-superior#ixzz3uZ3EQwx6I assume that Sanofi paid to bring the Super 12 Afrezza users out to San Diego and get their first hand experiences just for this purpose: design of clinical trials to demonstrate optimal use of Afrezza. They will probably not perform superiority comparisons. Those are difficult trials as they depend so much on patient reported outcomes and honest compliance. If the data is as good as it seems to be for the Super 12, comparisons will be unnecessary. The first 2 Afrezza PMR studies are complete and Sanofi is recruiting for the 3rd (pediatric safety study). In addition to those results from the controlled euglycemic clamp and PK/PD clinical studies, they need to understand absolute and temporal dosing requirements in real life Afrezza use. I have to assume that is why Sanofi (Marketing, Clinical/Regulatory groups) are following the experiences of more public early Afrezza adopters and Afrezza users in general, and MEETING with them in person to discuss. The intentions were to get user information in order to develop clinical trial design and consider changes in specific dosing instructions/labeling. The primary outcomes data would include time in normal BG range, high BG and low BG, along with pre-treatment and post-treatment HbA1c's. I believe that Sanofi is not giving up on Afrezza. Phase 4 studies are done all the time to improve claims and optimize dosing, etc. At least in my opinion, Sanofi is just putting one foot in front of the other in a disciplined approach to setting Afrezza up as the next greatest thing in diabetes. |
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Post by mnholdem on Dec 17, 2015 9:48:58 GMT -5
I know that this would be an unexpected surprise, but I wonder whether the post-marketing trials that were just completed could lead to a First-in-Class designation for Afrezza as an Ultra- or Super-Fast Acting insulin. This could virtually eliminate insurance coverage problems, since there would no competing insulin in that category. Drs. Edelman, Bode and several other diabetes experts have publicly stated that the PK/PD profile from the pre-approval FDA trials merited a new class of insulin. Could the two postmarket trials cause the FDA to reconsider? Although the odds are probably 1 to 100 in my opinion, the FDA has some making up to do after the Martin Shkreli scandal which led to the 2nd CRL. With Shkreli having just been arrested, I would think that the FDA is a little nervous about the implications of their response to outside influence of a hedge fund manager (which is illegal) when the FDA commissioner at the time (Margaret Hamburg) had a husband who also works for a hedge fund. A label change to Ultra/Super-Fast Acting - what a wonderful holiday gift THAT would be, eh? Don't beat me up too badly...after all, I only give it 1:100 odds.   |
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Post by tommix321 on Dec 17, 2015 10:57:28 GMT -5
I know that this would be an unexpected surprise, but I wonder whether the post-marketing trials that were just completed could lead to a First-in-Class designation for Afrezza as an Ultra- or Super-Fast Acting insulin. This could virtually eliminate insurance coverage problems, since there would no competing insulin in that category. Drs. Edelman, Bode and several other diabetes experts have publicly stated that the PK/PD profile from the pre-approval FDA trials merited a new class of insulin. Could the two postmarket trials cause the FDA to reconsider? Although the odds are probably 1 to 100 in my opinion, the FDA has some making up to do after the Martin Shkreli scandal which led to the 2nd CRL. With Shkreli having just been arrested, I would think that the FDA is a little nervous about the implications of their response to outside influence of a hedge fund manager (which is illegal) when the FDA commissioner at the time (Margaret Hamburg) had a husband who also works for a hedge fund. A label change to Ultra/Super-Fast Acting - what a wonderful holiday gift THAT would be, eh? Don't beat me up too badly...after all, I only give it 1:100 odds. No, insurance companies don't care whether it's "super" or "ultra" anything unless that "super" or "ultra" translates into something that improves their bottom line. Until afrezza has solid clinical data showing it significantly outperforms lispro in terms of diabetic health -- e.g. fewer trips to the ER, fewer diabetic related complications, etc -- then insurance will opt for cheaper. |
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Post by figglebird on Dec 17, 2015 11:12:56 GMT -5
That is SO not necessarily true - though it is a prandial its not a bio similar w respect to subq's - Furthermore because the FDA chose not to recognize this difference with respect to the parameters placed on phase studies, despite a cogent and persuasive analysis to do so, Insurance companies now, will, in fold come to recognize this substantive difference - as the product continues to distinguish itself.
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