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Post by mnkdfann on Nov 5, 2018 23:08:26 GMT -5
This seems like a pretty pointless discussion. The FDA required the study of a "5-year, randomized, controlled trial in 8,000-10,000 patients with type 2 diabetes to assess the serious potential risk of pulmonary malignancy with Afrezza use." Unless and until the FDA cancels this requirement, how can anyone say that less evidence is demonstrably enough to satisfy the FDA on this point?
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Post by longliner on Nov 6, 2018 0:17:24 GMT -5
Wonderful to hear your insight into what FDA requires as well as your support for "Aged Hippie"! Whatever happened to reverselo? The two of you were so close.
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Post by mango on Nov 6, 2018 0:27:06 GMT -5
This seems like a pretty pointless discussion. The FDA required the study of a "5-year, randomized, controlled trial in 8,000-10,000 patients with type 2 diabetes to assess the serious potential risk of pulmonary malignancy with Afrezza use." Unless and until the FDA cancels this requirement, how can anyone say that less evidence is demonstrably enough to satisfy the FDA on this point? Afrezza does not cause pulmonary malignancies and that is a scientific fact. That is consistent with our objective reality, and has been repeatably verified and proven with scientific evidence. Why must we ignore scientific facts? These shenanigans are literally hindering peoples' access to this insulin and there's like a billion people on this planet with diabetes.
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Post by longliner on Nov 6, 2018 0:58:38 GMT -5
I'm just curious, between mnkdfann and aged hippie there are over 5000 posts on proboards alone, do either of you invest in or use Mannkind products? Will positive FDA approvals for Mannkind products adversely affect your employer's financial or your personal financial position (as this is about FDA approvals). I invest in, but do not use the products. I realize the moderators would prefer to keep the conversation cerebral, but quite honestly I find the continued negative drumbeat offensive as a long term investor. The "thing" on Yahoo MSG Board seems to capture enough of this vibe for all platforms.
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Post by compound26 on Nov 6, 2018 1:53:20 GMT -5
I'm just curious, between mnkdfann and aged hippie there are over 5000 posts on proboards alone, do either of you invest in or use Mannkind products? Will positive FDA approvals for Mannkind products adversely affect your employer's financial or your personal financial position (as this is about FDA approvals). I invest in, but do not use the products. I realize the moderators would prefer to keep the conversation cerebral, but quite honestly I find the continued negative drumbeat offensive as a long term investor. The "thing" on Yahoo MSG Board seems to capture enough of this vibe for all platforms. Can't agree more on this.
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Post by myocat on Nov 6, 2018 8:05:22 GMT -5
My daughter age 16 and a monogenic diabetic had stopped using Lantus this week. She is still using humalog at meal time, however. We asked her endo to write off label Afreza. We got it but I hesitated and I have not filled the Rx. You see, that lung cancer cloud is hanging over my head and we'll wait for a few more years.
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Post by beefmafioso on Nov 6, 2018 8:28:51 GMT -5
So I research diabetes and treatment for diabetes. ... he should be more concerned about the Frankenstein GMO insulins most PWDs are currently taking. ... insulin - afrezza versus taking an engineered analog like Novolog
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Post by mnkdfann on Nov 6, 2018 8:31:29 GMT -5
Wonderful to hear your insight into what FDA requires as well as your support for "Aged Hippie"! Whatever happened to reverselo? The two of you were so close. I guess you were too obtuse to recognize that my 'insight' into what the FDA requires was cut and pasted direct from the FDA site itself (and had nothing to do with Aged Hippie). If the FDA material upset you, take that up with it.
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Post by beefmafioso on Nov 6, 2018 8:37:18 GMT -5
Dr. Edelman call Nordisk's AspB10 Frankenstein insulin. Dr.Kendall Calls Needles Barbaric. Halloween is over & technology is here now. Big Pharma doesn't care bought your teen. They are in it to make $.
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Post by mnkdfann on Nov 6, 2018 8:40:43 GMT -5
This seems like a pretty pointless discussion. The FDA required the study of a "5-year, randomized, controlled trial in 8,000-10,000 patients with type 2 diabetes to assess the serious potential risk of pulmonary malignancy with Afrezza use." Unless and until the FDA cancels this requirement, how can anyone say that less evidence is demonstrably enough to satisfy the FDA on this point? Afrezza does not cause pulmonary malignancies and that is a scientific fact. That is consistent with our objective reality, and has been repeatably verified and proven with scientific evidence. Why must we ignore scientific facts? These shenanigans are literally hindering peoples' access to this insulin and there's like a billion people on this planet with diabetes. In case you missed it, I was also quoting from the FDA site and not giving an opinion about evidence. You may well be correct about many things but AFAIK the FDA has not changed its mind on requiring the pulmonary malignancy trial.
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Post by agedhippie on Nov 6, 2018 8:41:32 GMT -5
Agedhippie-. You work hard here on this message board and quite honestly, I'm not convinced you are a Type 2. I am convinced however that you are here for FUDster extraordinairre (sP?). Please respond to Mango. TYIA. You would be quite right not to be convinced that I am not a Type 2, I am a Type 1. Response to Mango below...
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Post by agedhippie on Nov 6, 2018 8:46:45 GMT -5
This seems like a pretty pointless discussion. The FDA required the study of a "5-year, randomized, controlled trial in 8,000-10,000 patients with type 2 diabetes to assess the serious potential risk of pulmonary malignancy with Afrezza use." Unless and until the FDA cancels this requirement, how can anyone say that less evidence is demonstrably enough to satisfy the FDA on this point? Afrezza does not cause pulmonary malignancies and that is a scientific fact. That is consistent with our objective reality, and has been repeatably verified and proven with scientific evidence. Why must we ignore scientific facts? These shenanigans are literally hindering peoples' access to this insulin and there's like a billion people on this planet with diabetes. I would agree (as does my endo) that it is very unlikely that Afrezza causes lung cancer. However the FDA has been burnt by problems with diabetes drugs (hence the CVOT trials) and is saying it's unlikely but prove it with a trial of people with a disposition towards lung cancer. Since the FDA is the judge and jury in this matter it has to be done as they wish.
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Post by agedhippie on Nov 6, 2018 8:55:17 GMT -5
I'm just curious, between mnkdfann and aged hippie there are over 5000 posts on proboards alone, do either of you invest in or use Mannkind products? Will positive FDA approvals for Mannkind products adversely affect your employer's financial or your personal financial position (as this is about FDA approvals). I invest in, but do not use the products. I realize the moderators would prefer to keep the conversation cerebral, but quite honestly I find the continued negative drumbeat offensive as a long term investor. The "thing" on Yahoo MSG Board seems to capture enough of this vibe for all platforms. I do not, nor have I ever, worked for anyone with a financial interest in the success or failure of Afrezza. In the past I have invested in Mannkind, but sold once the reverse split was announced, and since then I have from time to time bought Calls. As far as I am aware I have posted in this forum every time I bought or sold them. You didn't ask, but for the record I have never posted on Mannkind or Afrezza anywhere other than this forum.
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Post by mango on Nov 6, 2018 9:34:23 GMT -5
Afrezza does not cause pulmonary malignancies and that is a scientific fact. That is consistent with our objective reality, and has been repeatably verified and proven with scientific evidence. Why must we ignore scientific facts? These shenanigans are literally hindering peoples' access to this insulin and there's like a billion people on this planet with diabetes. I would agree (as does my endo) that it is very unlikely that Afrezza causes lung cancer. However the FDA has been burnt by problems with diabetes drugs (hence the CVOT trials) and is saying it's unlikely but prove it with a trial of people with a disposition towards lung cancer. Since the FDA is the judge and jury in this matter it has to be done as they wish. We've already proven it, how many times does something need to be proven in order for someone to believe? Anyways, I would argue that FDA is not going to require it based on already established scientific facts and ongoing verified evidence from post-approval clinical trials and real-world evidence and data. You can also bet your butt that FDA takes seriously any reported adverse events and also social media reports, both positive and negative user reports and reviews, they use a software protocol that monitors social media sites for mining key words. How do I know that? Because I read it straight off FDA website on a slide they made and presented during a post-approval surveillence committee review meeting something-another. I've had a dialogue with an CDER pharmacist about insulins, and I am pretty confident that FDA is aware of what is going on, and even I have a hard time believing that. Maybe so, maybe not, but in the meantime we'll keep prescribing Afrezza, educating the medical and scientific communities and saving lives.
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Post by dh4mizzou on Nov 6, 2018 9:36:06 GMT -5
My daughter age 16 and a monogenic diabetic had stopped using Lantus this week. She is still using humalog at meal time, however. We asked her endo to write off label Afreza. We got it but I hesitated and I have not filled the Rx. You see, that lung cancer cloud is hanging over my head and we'll wait for a few more years. Not to be a azz but you might not want your daughter to leave the house. She could be bullied, or hit by a car, or kidnapped, or ......... well I think you get the picture.
One could argue that there is a greater chance that one of the things I mentioned happening are greater than her getting lung cancer. Of course that is unless she smokes.
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