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Post by dreamboatcruise on Sept 27, 2017 16:06:46 GMT -5
Here's one paper from 2012 with trial results. That took me all of 10 seconds to find with google. I do remember that the term was used quite a bit... perhaps in anticipation the FDA would approve it... but if so that wouldn't be the only time MNKD failed to correctly anticipate FDA's actions. www.ncbi.nlm.nih.gov/pmc/articles/PMC3440146I said trials. I did not say a paper. This is the trial mentioned in the paper and it does not have the word ultra in the trial. This is some of the researchers of the trial presenting results. What are you trying to get at? By use "in the trial"... do you mean the doctor saying "this is an ultra rapid insulin" to a trial participant? I wouldn't know that. The point is that Afrezza has long been referred to as ultra-rapid, by MNKD and by others... despite now being disallowed from saying that in marketing. Seeing the term in non-marketing context means nothing regarding label approval. These university researchers could have called it a super-duper-amazing insulin... assuming they wouldn't mind losing credibility as researchers. [edit] Ha... or quick-like-a-bunny insulin. Thanks Baba. I do kinda like fast-like-a-bat-out-of-hell insulin... but for some reason I suspect that might not get approved. It doesn't seem like FDA has a sense of humor.
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Post by mango on Sept 27, 2017 17:35:05 GMT -5
I said trials. I did not say a paper. This is the trial mentioned in the paper and it does not have the word ultra in the trial. This is some of the researchers of the trial presenting results. What are you trying to get at? By use "in the trial"... do you mean the doctor saying "this is an ultra rapid insulin" to a trial participant? I wouldn't know that. The point is that Afrezza has long been referred to as ultra-rapid, by MNKD and by others... despite now being disallowed from saying that in marketing. Seeing the term in non-marketing context means nothing regarding label approval. These university researchers could have called it a super-duper-amazing insulin... assuming they wouldn't mind losing credibility as researchers. [edit] Ha... or quick-like-a-bunny insulin. Thanks Baba. I do kinda like fast-like-a-bat-out-of-hell insulin... but for some reason I suspect that might not get approved. It doesn't seem like FDA has a sense of humor. I didn't laugh at that but I do continue to laugh at the fact you will argue that Fiasp will become ultra-rapid. Yep, pretty damn slow.
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Post by drman7 on Sept 27, 2017 17:47:22 GMT -5
This is some of the researchers of the trial presenting results. What are you trying to get at? By use "in the trial"... do you mean the doctor saying "this is an ultra rapid insulin" to a trial participant? I wouldn't know that. The point is that Afrezza has long been referred to as ultra-rapid, by MNKD and by others... despite now being disallowed from saying that in marketing. Seeing the term in non-marketing context means nothing regarding label approval. These university researchers could have called it a super-duper-amazing insulin... assuming they wouldn't mind losing credibility as researchers. [edit] Ha... or quick-like-a-bunny insulin. Thanks Baba. I do kinda like fast-like-a-bat-out-of-hell insulin... but for some reason I suspect that might not get approved. It doesn't seem like FDA has a sense of humor. I didn't laugh at that but I do continue to laugh at the fact you will argue that Fiasp will become ultra-rapid. Yep, pretty damn slow. I think dreamboatcruise has been having too many nightmares or maybe he needs to change his handle to loveboatcruise. G)
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Post by careful2invest on Sept 27, 2017 17:48:55 GMT -5
This is some of the researchers of the trial presenting results. What are you trying to get at? By use "in the trial"... do you mean the doctor saying "this is an ultra rapid insulin" to a trial participant? I wouldn't know that. The point is that Afrezza has long been referred to as ultra-rapid, by MNKD and by others... despite now being disallowed from saying that in marketing. Seeing the term in non-marketing context means nothing regarding label approval. These university researchers could have called it a super-duper-amazing insulin... assuming they wouldn't mind losing credibility as researchers. [edit] Ha... or quick-like-a-bunny insulin. Thanks Baba. I do kinda like fast-like-a-bat-out-of-hell insulin... but for some reason I suspect that might not get approved. It doesn't seem like FDA has a sense of humor. I didn't laugh at that but I do continue to laugh at the fact you will argue that Fiasp will become ultra-rapid. Yep, pretty damn slow. While I admit that it is less and less prominant than in the past, but DBC (while extremely knowledgable) often sounds almost like a soft basher of AFREZZA and Mannkind in general, as do other "self proclaimed longs" on this mb. Just an observation.
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Post by dreamboatcruise on Sept 27, 2017 17:49:11 GMT -5
mango... I've never weighed in one way or the other whether I think the FDA will approve that for Fiasp. I continue to be amused at how you make up things to attack. As far as I know you are the only person here on the board that is claiming to know which way the FDA would go with that. I don't have that level of hubris to claim I can predict FDA decisions. Obviously if any of us really could predict FDA decisions consistently we'd be filthy rich already and cruising on our yacht. I have posted talking about the effect I think an FDA decision on Fiasp might have on Afrezza, but I clearly posed both sides of that coin, approved and not approved.
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Post by dreamboatcruise on Sept 27, 2017 18:02:42 GMT -5
careful2invest ... yes, yes, yeda, yada. I've posted many of my purchases when I made them. I'm willing to pick a neutral party such as one of our mods. I'll send my brokerage statements and you can send yours. We can wee who is longer... and has been longer for longer. By the way, please explain how telling Mango that MNKD has indeed used "ultra-rapid" in the past is soft bashing? That's bizarro to me. It's a fact, plain and simple. Is Mango somehow your ultimate long that no one can question... eyes rolling. Perhaps you should have a new proboard forum for the Mango fan club. That board could be a no fact zone, where people only post opinion and wishes and Mango is the arbiter of which opinion is considered gospel.
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Post by sayhey24 on Sept 27, 2017 18:19:49 GMT -5
mango ... I've never weighed in one way or the other whether I think the FDA will approve that for Fiasp. I continue to be amused at how you make up things to attack. As far as I know you are the only person here on the board that is claiming to know which way the FDA would go with that. I don't have that level of hubris to claim I can predict FDA decisions. Obviously if any of us really could predict FDA decisions consistently we'd be filthy rich already and cruising on our yacht. I have posted talking about the effect I think an FDA decision on Fiasp might have on Afrezza, but I clearly posed both sides of that coin, approved and not approved. If the FDA gives afrezza the ultra label first they will be hard pressed to give it to Fiasp simply because there is night and day between the two and if I were Mike I would introduce them to my lawyer before the Fiasp decision was made and force them to prove non-inferiority for time in range and not A1c. Now, I am in the camp the FDA will delay and delay the MNKD decision and approve Fiasp first. Then again we have the Trump-effect so I would hedge that bet AND there are so many injection site issues with Fiasp it really should not be approved at all. With the Adcom I had the hubris to go all in and won the bet against Adam F. If I had to pick a side on this one, I am going with Mango but I really hate "ultra" as afrezza is not an ultra RAA in fact its not an analog at all. It should be labeled NNR "near natural release".
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Post by chyaboi on Sept 27, 2017 18:21:44 GMT -5
careful2invest ... yes, yes, yeda, yada. I've posted many of my purchases when I made them. I'm willing to pick a neutral party such as one of our mods. I'll send my brokerage statements and you can send yours. We can wee who is longer... and has been longer for longer. By the way, please explain how telling Mango that MNKD has indeed used "ultra-rapid" in the past is soft bashing? That's bizarro to me. It's a fact, plain and simple. Is Mango somehow your ultimate long that no one can question... eyes rolling. Perhaps you should have a new proboard forum for the Mango fan club. That board could be a no fact zone, where people only post opinion and wishes and Mango is the arbiter of which opinion is considered gospel. Mango did actually provide the facts. Your claim wasn't correct with the inaccurate back-up. Mango and a few others frequently provide back-up with their claims and opinions.You on the other hand don't usually and always have a negative spin. Keep crying why don't you and start a MNKD con-board.
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Post by dreamboatcruise on Sept 27, 2017 18:31:05 GMT -5
sayhey24... It isn't currently labeled as an RAA ("AFREZZA® is a rapid acting inhaled insulin" per insert) so don't think you need to worry about that. I won betting on the time it actually got approved, but lost on prior attempts. Of course what I won betting on approval, has now been lost and more as I averaged down from our post approval high. I'll stick with not taking a position on Fiasp label approval. Have you found anyone to take you and Mango up on the opposite side of that prediction? I also would not be very surprised at delay for Afrezza new designation. Though I'm hopeful that Mike's seeming confidence in a decision now means something. We shall see... and that will begin to inform me how much credibility to put into Mike's hints.
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Post by dreamboatcruise on Sept 27, 2017 18:40:20 GMT -5
chyaboi... please be specific what you are talking about. This thread started with me pointing out not to read too much into use of "ultra rapid" in describing one of our new studies because the FDA doesn't regulate that. Are you stating that you think they would not be allowed to say ultra-rapid in the trial description without approval, or are you merely trying to be combative? Please explain why you believe that my position about the meaning of this use of "ultra-rapid" is wrong. I'm all ears. If you have a genuine belief that I'm wrong about that I'll try to address our disagreement in a civil discussion of the facts... but not if you're just acting like this is jr high debate club. Inaccurate backup... good lord, I just strained my optic nerve my eyes rolled back so far. If that paper is inaccurate write to the authors, don't complain to me. If you mean something else, learn to express yourself.
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Post by chyaboi on Sept 27, 2017 23:40:58 GMT -5
chyaboi... please be specific what you are talking about. This thread started with me pointing out not to read too much into use of "ultra rapid" in describing one of our new studies because the FDA doesn't regulate that. Are you stating that you think they would not be allowed to say ultra-rapid in the trial description without approval, or are you merely trying to be combative? Please explain why you believe that my position about the meaning of this use of "ultra-rapid" is wrong. I'm all ears. If you have a genuine belief that I'm wrong about that I'll try to address our disagreement in a civil discussion of the facts... but not if you're just acting like this is jr high debate club. Inaccurate backup... good lord, I just strained my optic nerve my eyes rolled back so far. If that paper is inaccurate write to the authors, don't complain to me. If you mean something else, learn to express yourself. The paper you found from 2012 that states "ultra rapid" is a paper. There is nothing wrong with the paper. The area where you may be mistaken and has been pointed out to you, is that the STAT Study that is going to begin clinical trials uses "ultra rapid" to describe Afrezza. The thread has commented that we haven't seen a trial stating afrezza is "ultra rapid". You claimed you did, but the paper you pointed out is not a trial. Do you need me to break this down anymore? Hope your eyes are okay....
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Post by digger on Sept 27, 2017 23:41:09 GMT -5
mango ... I've never weighed in one way or the other whether I think the FDA will approve that for Fiasp. I continue to be amused at how you make up things to attack. As far as I know you are the only person here on the board that is claiming to know which way the FDA would go with that. I don't have that level of hubris to claim I can predict FDA decisions. Obviously if any of us really could predict FDA decisions consistently we'd be filthy rich already and cruising on our yacht. I have posted talking about the effect I think an FDA decision on Fiasp might have on Afrezza, but I clearly posed both sides of that coin, approved and not approved. If the FDA gives afrezza the ultra label first they will be hard pressed to give it to Fiasp simply because there is night and day between the two and if I were Mike I would introduce them to my lawyer before the Fiasp decision was made and force them to prove non-inferiority for time in range and not A1c. Now, I am in the camp the FDA will delay and delay the MNKD decision and approve Fiasp first. Then again we have the Trump-effect so I would hedge that bet AND there are so many injection site issues with Fiasp it really should not be approved at all. With the Adcom I had the hubris to go all in and won the bet against Adam F. If I had to pick a side on this one, I am going with Mango but I really hate "ultra" as afrezza is not an ultra RAA in fact its not an analog at all. It should be labeled NNR "near natural release". The fiasp label doesn't claim to be ultrafast: www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/OurProducts/PDF/fiasp-consumer-information.pdfAll it says is "Fiasp is a fast-acting mealtime insulin aspart formulation used to treat diabetes. Fiasp will start to lower your blood sugar within 20 minutes after starting a meal."
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Post by dreamboatcruise on Sept 28, 2017 1:26:18 GMT -5
chyaboi ... please be specific what you are talking about. This thread started with me pointing out not to read too much into use of "ultra rapid" in describing one of our new studies because the FDA doesn't regulate that. Are you stating that you think they would not be allowed to say ultra-rapid in the trial description without approval, or are you merely trying to be combative? Please explain why you believe that my position about the meaning of this use of "ultra-rapid" is wrong. I'm all ears. If you have a genuine belief that I'm wrong about that I'll try to address our disagreement in a civil discussion of the facts... but not if you're just acting like this is jr high debate club. Inaccurate backup... good lord, I just strained my optic nerve my eyes rolled back so far. If that paper is inaccurate write to the authors, don't complain to me. If you mean something else, learn to express yourself. The paper you found from 2012 that states "ultra rapid" is a paper. There is nothing wrong with the paper. The area where you may be mistaken and has been pointed out to you, is that the STAT Study that is going to begin clinical trials uses "ultra rapid" to describe Afrezza. The thread has commented that we haven't seen a trial stating afrezza is "ultra rapid". You claimed you did, but the paper you pointed out is not a trial. Do you need me to break this down anymore? Hope your eyes are okay.... I claimed what? I presented something. Show me where I claimed anything beyond what I showed. Guess I need frown face for someone making up BS. If you want to dispute the original point I made... that the description written by a university researcher does not have some indication about the pending FDA decision on labeling, ok... but do that... don't be a weasel troll. Sorry dude.
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Post by chyaboi on Sept 28, 2017 8:29:42 GMT -5
The paper you found from 2012 that states "ultra rapid" is a paper. There is nothing wrong with the paper. The area where you may be mistaken and has been pointed out to you, is that the STAT Study that is going to begin clinical trials uses "ultra rapid" to describe Afrezza. The thread has commented that we haven't seen a trial stating afrezza is "ultra rapid". You claimed you did, but the paper you pointed out is not a trial. Do you need me to break this down anymore? Hope your eyes are okay.... I claimed what? I presented something. Show me where I claimed anything beyond what I showed. Guess I need frown face for someone making up BS. If you want to dispute the original point I made... that the description written by a university researcher does not have some indication about the pending FDA decision on labeling, ok... but do that... don't be a weasel troll. Sorry dude. Not weaseling at all or making stuff up, being quite direct actually. It's a bit difficult to have a debate, like a jr high debate as you say, with someone who disregards the point trying to be made and argues another point to avoid from the other one. The frown face was suppose to be 3 question marks, but it changed into a frown face by the way. Good luck to you and your investment (if you still have one) in MNKD. Next week and the next few months should be interesting as they all are.
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Post by mnkdfann on Sept 28, 2017 8:38:44 GMT -5
If the FDA gives afrezza the ultra label first they will be hard pressed to give it to Fiasp simply because there is night and day between the two and if I were Mike I would introduce them to my lawyer before the Fiasp decision was made and force them to prove non-inferiority for time in range and not A1c. Now, I am in the camp the FDA will delay and delay the MNKD decision and approve Fiasp first. Then again we have the Trump-effect so I would hedge that bet AND there are so many injection site issues with Fiasp it really should not be approved at all. With the Adcom I had the hubris to go all in and won the bet against Adam F. If I had to pick a side on this one, I am going with Mango but I really hate "ultra" as afrezza is not an ultra RAA in fact its not an analog at all. It should be labeled NNR "near natural release". The fiasp label doesn't claim to be ultrafast: www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/OurProducts/PDF/fiasp-consumer-information.pdfAll it says is "Fiasp is a fast-acting mealtime insulin aspart formulation used to treat diabetes. Fiasp will start to lower your blood sugar within 20 minutes after starting a meal." FWIW, that (Canadian market?) leaflet you linked to (not sure that is the same thing as the 'label' itself) says more than that. For instance, it also says "The onset of effect for Fiasp® is twice as fast when compared to NovoRapid®." and "Due to the faster onset of action, Fiasp® should be injected up to 2 minutes before the start of a meal." So it is certainly saying Fiasp is FASTER than alternatives. Agreed, though, it does not use the specific word 'ultrafast'.
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