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Post by mnkdfann on Jun 10, 2019 14:38:05 GMT -5
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Post by sr71 on Jun 10, 2019 16:19:49 GMT -5
From the link (bold emphasis added):
"Program Overview
This webinar is sponsored by MannKind Corporation.
Mealtime glucose control isn’t always easy for today’s patients. AFREZZA, the only inhaled insulin on the market with an ultra-rapid absorption feature, delivers mealtime glucose control in a unique way."
Hmmm (:>
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Post by golfeveryday on Jun 10, 2019 16:30:57 GMT -5
From the link (bold emphasis added): "Program Overview This webinar is sponsored by MannKind Corporation. Mealtime glucose control isn’t always easy for today’s patients. AFREZZA, the only inhaled insulin on the market with an ultra-rapid absorption feature, delivers mealtime glucose control in a unique way." Hmmm (:> that’s interesting...didn’t think they could use that...maybe they submitted a label change many months ago and expect a response by the FDA prior to the 20th? Hmm... |
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Post by sayhey24 on Jun 10, 2019 17:28:06 GMT -5
They now have a patent which is for ultra rapid.
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Post by golfeveryday on Jun 10, 2019 17:36:31 GMT -5
They now have a patent which is for ultra rapid. . But they can’t claim it until approved by FDA. |
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Post by cjm18 on Jun 10, 2019 18:00:36 GMT -5
From the link (bold emphasis added): "Program Overview This webinar is sponsored by MannKind Corporation. Mealtime glucose control isn’t always easy for today’s patients. AFREZZA, the only inhaled insulin on the market with an ultra-rapid absorption feature, delivers mealtime glucose control in a unique way." Hmmm (:> that’s interesting...didn’t think they could use that...maybe they submitted a label change many months ago and expect a response by the FDA prior to the 20th? Hmm... |
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Post by golfeveryday on Jun 10, 2019 18:17:29 GMT -5
that’s interesting...didn’t think they could use that...maybe they submitted a label change many months ago and expect a response by the FDA prior to the 20th? Hmm... regardless, they can’t say it unless approved. |
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Post by boytroy88 on Jun 10, 2019 19:00:32 GMT -5
regardless, they can’t say it unless approved. So does that mean it's been approved but they forgot to announced it!? |
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Post by theshiv on Jun 10, 2019 19:30:52 GMT -5
regardless, they can’t say it unless approved. So does that mean it's been approved but they forgot to announced it!? This would be important news. I would think an announcement would be coming. Hopefully this is not a gross oversight in either direction. |
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Post by peppy on Jun 10, 2019 19:46:39 GMT -5
I see the distinction. the only inhaled insulin on the market with an ultra-rapid absorption feature, delivers mealtime glucose control in a unique way. |
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Post by letitride on Jun 10, 2019 19:47:11 GMT -5
They now have a patent which is for ultra rapid. . But they can’t claim it until approved by FDA. I believe they just did, maybe there going to make the FDA prove otherwise. |
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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 golfeveryday on Jun 10, 2019 21:12:48 GMT -5
Could it be that an instructional webinar is simply not subject to the same FDA rules as an advertisement? definitely not |
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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 golfeveryday on Jun 10, 2019 21:50:11 GMT -5
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. if they are sponsoring it they can only say what is in the currently approved label. |
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