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Post by sayhey24 on Jun 5, 2022 18:41:56 GMT -5
I can’t find anything, would be nice if somebody could:-) Sports - thanks for looking. Everything at the conference is copyrighted but I thought maybe someone might have videoed something. If the show was really good I had hoped "Buzz" Harris would have held a press conference before/after the show and would have provided a preview/recap of the show and that could have been "officially" recorded and releasable. |
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Post by phdedieu12 on Jun 5, 2022 20:00:34 GMT -5
Just asked Mike if there is something anywhere, will post if anything is available
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Post by phdedieu12 on Jun 5, 2022 21:03:02 GMT -5
The session was recorded but as Sayhey mentioned it's copyrighted and not available to the public
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Post by akemp3000 on Jun 5, 2022 21:39:52 GMT -5
If it got really good attention, it would great to see a small market reaction tomorrow.
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Post by veritasfiliatemporis on Jun 6, 2022 14:47:58 GMT -5
At 10 still sleeping, at 12 waiting the lunch, 14 digesting, 16 thinking about the happy hour event but at 1630 all present at Mannkind presentation before the happy hour that starts at 1730.. Any news regarding the presentation before the Happy Hour... |
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Post by agedhippie on Jun 6, 2022 15:04:19 GMT -5
Aged - I think you mean ADA class but until the ADA defines the class its more of a marketing thing. ... No, I mean FDA  This is their leaflet and it even mentions Afrezza! ( www.fda.gov/media/119149/download) The FDA insulin classes are: Rapid Acting, Short Acting, Intermediate Acting, Long acting, and (spit) pre-mixed. Afrezza is classed as Rapid Acting. |
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Post by sayhey24 on Jun 6, 2022 15:21:26 GMT -5
Aged - I think you mean ADA class but until the ADA defines the class its more of a marketing thing. ... No, I mean FDA  This is their leaflet and it even mentions Afrezza! ( www.fda.gov/media/119149/download) The FDA insulin classes are: Rapid Acting, Short Acting, Intermediate Acting, Long acting, and (spit) pre-mixed. Afrezza is classed as Rapid Acting. Hmmm - I am going to have to look into this a little more. While this is clearly an FDA booklet its an "informational booklet" and I think they are using the ADA classifications in the booklet from the ADA SoC. I think the only classification the FDA has for insulin is as a biologic. But I could be wrong, it happens. www.diabetes.org/blog/insulin-now-biologic-what-does-mean |
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Post by mango on Jun 6, 2022 17:30:26 GMT -5
I think it’s a bit of a grey area. On one hand ADA regulates the SoC and thus insulin speed classifications. FDA has nothing to do with giving out guidance on diabetes management algorithms or diabetes medical decision making. But on the other hand, FDA regulates marketing and the language companies use in their ads, websites, etc.
It would appear FDA does not disagree that Afrezza is the world’s only ultra rapid acting inhaled insulin or else we would have had that ripped off the websites long ago.
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Post by sayhey24 on Jun 6, 2022 18:21:44 GMT -5
Mango - after some further research it seems these classifications are from the ADA and the FDA's reproduction of the ADA's copyrighted material for governmental educational use would be covered under section 107 of the Copyright Act of 1976, or so it appears. I have a question out to the FDA to confirm.
I would not go as far as to say the FDA does not disagree that afrezza is ultra rapid acting. I think no one has yet challenged MNKD's use of "ultra" with the FDA. Its not currently an ADA category. MNKD just made it up and if I remember correctly we discussed this several years ago that MNKD should start calling it 'ULTRA" until this was challenged. The thing is who would be dumb enough to challenge it? Who knows maybe Mike got the idea from Proboards. Stranger things have happened.
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