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Post by mnkdfann on Jun 11, 2019 10:39:18 GMT -5
Yes, at a minimum why isn't the ADA doing a study to validate Afrezza instead of starting research from scratch on another drug. that's the key question. Followed by when is Kendall going to get in their face about it. They do have eyes don't they. They can see the science of replicating what the body does using Afrezza. Agedhippie answered this on the first page of this thread: "It's all about the artificial pancreas. URLi and FIASP have less than ideal profiles for a rapid in/rapid out insulin, and Afrezza is a non-starter because you cannot automatically dispense it, so the ADA is funding research into a rapid in/rapid out pumpable insulin." His answer made sense, I thought. |
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Post by mnkdfann on Jun 10, 2019 21:47:11 GMT -5
Could it be that an instructional webinar is simply not subject to the same FDA rules as an advertisement? definitely not I respect your opinion, but it would be nice to hear why you say that. The FDA regulates ads. The webinar (as I see it) is not an ad. It seems the phrase ultra-rapid has certainly been applied to Afrezza in the past. E.g. see the last paragraph in this: diatribe.org/fda-approves-faster-acting-mealtime-insulinOf course, Mannkind did not write that article. While Mannkind is sponsoring the webinar, it is offered by the AADE, not targetted to consumers, and maybe it is arms length enough from Mannkind that the language can be looser. Of course, and I hope, someone with more energy than I should feel free to email IR at Mannkind and see what they have to say about it. |
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Post by mnkdfann on Jun 10, 2019 19:54:44 GMT -5
Could it be that an instructional webinar is simply not subject to the same FDA rules as an advertisement?
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Post by mnkdfann on Jun 10, 2019 14:38:27 GMT -5
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Post by mnkdfann on Jun 10, 2019 14:38:05 GMT -5
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Post by mnkdfann on Jun 9, 2019 22:27:53 GMT -5
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Post by mnkdfann on Jun 8, 2019 15:12:44 GMT -5
sdrc.stanford.edu/eric-appel"The Appel lab at Stanford integrates concepts and approaches from supramolecular chemistry and natural/synthetic materials to tackle healthcare challenges of critical importance to society, including diabetes mellitus. They have developed a platform of materials with unique, tunable, and stimuli-responsive properties that they are exploiting as the basis for novel treatment strategies for a range of disease targets. Relevant to diabetes, Appel’s group has developed “smart” excipient technology affording unprecedented stabilization of monomeric insulin, a strategy that forms the basis of novel ultra-fast-acting insulin formulations for treatment of diabetes. They have several on-going collaborations with multiple members of the Stanford DRC that focus on the translation of their new material technologies."
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Post by mnkdfann on Jun 8, 2019 15:09:55 GMT -5
So on April 1st Appel said "I found the solution ... it is called Afrezza." And pockets the $$$. Obviously, the ADA was P'Oed that Dr. Kendall left and went to Mannkind. Well, if only. More like, Kendall left the ADA, and no one else left there knows much or cares much about Afrezza. |
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Post by mnkdfann on Jun 8, 2019 14:05:04 GMT -5
As an aside, One would think that Rose would have vetted any comments with upper management before sharing them on any platform. YMMV, but I think it is clear by now that they do not run that tight a ship. |
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Post by mnkdfann on Jun 8, 2019 8:25:58 GMT -5
ST...$MNKD from Rose...."Thank you for your inquiry. You are correct. In Brazil, Afrezza is designated as an ultra rapid-acting mealtime insulin. In the US, Afrezza is designated as a rapid-acting inhaled insulin. We continue to pursue reclassification or creation of a new category with scientific data from trials." That is great news. This puts it in another category in Brazil. I would assume that will help with pricing since Afrezza will not be compared to the already crowded field of rapid-acting insulin. We will see. I'm just wondering, if Afrezza could get a better designation in Brazil than it did in the U.S., have none of its competitors done the same? |
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Post by mnkdfann on Jun 8, 2019 8:22:33 GMT -5
Y'all will love this story, I just know it. (In case it is not obvious to some, the above is sarcasm. In truth, I suspect many people will be upset / frustrated with what the article reports.) www.diabetesforecast.org/2019/02-mar-apr/ultra-rapid-acting-insulin.htmlYet even though drug manufacturers have been making various insulin formulations for more than a century, science still hasn’t found a way to produce formulas that supply insulin to the body in a way that matches—or at least very closely mimics—what happens in the healthy human body. That’s why the American Diabetes Association has given Appel a grant to help him engineer an ultra-rapid-acting insulin that starts working faster and, as a result, disappears from the bloodstream faster, too—all while remaining even more stable preinjection than state-of-the-art insulins on the market today. “If you were to have an insulin with faster onset as well as a much shorter [duration], it could be really beneficial,” says Appel. [Apologies if someone posted this previously; if so, I think I missed it.] |
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Post by mnkdfann on Jun 8, 2019 8:16:31 GMT -5
The protocol is now set for the India study and as we have been talking about for years on this board, CGMs don't lie. The medical community can no longer hide behind the A1c 3 month average and say its good enough. Is it now set? I thought it was still (as of about a month ago) being decided. Where can we find this protocol? |
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Post by mnkdfann on Jun 7, 2019 9:32:37 GMT -5
According to what I see on the web, Brandicourt is 63, fabulously well paid, French, lives in Paris.
Do you think MK is suggesting that he might move to Mannkind? Or else what? That new guy Hudson wants to buy / partner Mannkind?
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Post by mnkdfann on Jun 7, 2019 8:50:04 GMT -5
Portuguese is the official language of Brazil and the primary language used in most schools and media. It is also used for all business and administrative purposes. Brazil is the only Portuguese-speaking nation in the Americas, giving it a national culture sharply distinct from its Spanish-speaking neighbours. Brazilian Portuguese has had its own development, influenced by the other European languages such as Italian and German in the South and Southeast, and several indigenous languages all across the country. For this reason, Brazilian Portuguese differs significantly from European Portuguese and other dialects of Portuguese-speaking countries, even though they are all mutually intelligible. Such differences occur in phonetics and lexicon and have been compared to the differences between British English and American English.
en.wikipedia.org/wiki/Languages_of_Brazil . I know when I consulted at one of the major credit card companies back in the day I was surprised to learn that they translated ALL of the documents to Portuguese first and was told that was why. I think whoever told you that was mistaken, or there was some qualifier they left out. Like, maybe, the most spoken language in some limited region they serviced or something. According to links below, it IS the most spoken language in the Southern Hemisphere, and in South America. But certainly not world wide. www.fluentin3months.com/most-spoken-languages/en.wikipedia.org/wiki/Portuguese_language |
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Post by mnkdfann on Jun 6, 2019 13:12:21 GMT -5
"...and a 76% increase in time-in-range on CGMS, with no significant increase in hypoglycemia (Time<70 mg/dL)." 76% !!! I’d like to see that stated as total TIR since someone with uncontrolled bg probably doesn’t spend a lot of time in range to begin with. Increasing it by 100% may not yield a high total depending on the starting point. Kind of like increasing sales by 100% by selling two units versus one. From the table, it went from 37% TIR to 65%. A 76% increase. |
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