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Post by sayhey24 on Nov 7, 2016 19:42:03 GMT -5
Dexcom is running a commercial on TV with Dr. Steve Edelman. It would have been nice if they partnered with afrezza and showed the CGM detecting the high and how afrezza can quickly lower it.
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Deleted
Deleted Member
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Post by Deleted on Nov 7, 2016 19:51:47 GMT -5
Your imagination is not seeing an AD run by onDuo with Afrezza? stay tuned.
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Post by sayhey24 on Nov 7, 2016 19:57:25 GMT -5
Your imagination is not seeing an AD run by onDuo with Afrezza? stay tuned. How awesome would that be! I would say almost as awesome as Israel placing the $200M order. |
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Post by mannmade on Nov 7, 2016 20:24:23 GMT -5
Dexcom is running a commercial on TV with Dr. Steve Edelman. It would have been nice if they partnered with afrezza and showed the CGM detecting the high and how afrezza can quickly lower it. FDA would never allow. |
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Post by sayhey24 on Nov 7, 2016 20:35:06 GMT -5
Dexcom is running a commercial on TV with Dr. Steve Edelman. It would have been nice if they partnered with afrezza and showed the CGM detecting the high and how afrezza can quickly lower it. FDA would never allow. Why? |
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Post by agedhippie on Nov 7, 2016 21:30:37 GMT -5
Because the trial data and label do not support the display and so the result would be anecdotal hence you cannot use it. |
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Post by sayhey24 on Nov 8, 2016 6:31:59 GMT -5
Because the trial data and label do not support the display and so the result would be anecdotal hence you cannot use it. Since what you are showing is how the CGM shows and registers the results at various times I think with a small disclaimer it would be approved. Showing 2 products in one commercial would be a different ask for the FDA. |
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Post by agedhippie on Nov 8, 2016 8:20:27 GMT -5
Because the trial data and label do not support the display and so the result would be anecdotal hence you cannot use it. Since what you are showing is how the CGM shows and registers the results at various times I think with a small disclaimer it would be approved. Showing 2 products in one commercial would be a different ask for the FDA. What you show has to be consistent with the trial results. If we could prove the results we see from the early adopters we wouldn't be where we are now. Of course there is also the obvious question of why would Dexcom want to Afrezza - Dexcom wants to show the device tracking levels, what those levels are doesn't matter. Besides that if the graph is flat people might ask why they should bother buying a Dexcom since there appears to be no need to track. |
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Post by rockstarrick on Nov 8, 2016 8:42:41 GMT -5
Since what you are showing is how the CGM shows and registers the results at various times I think with a small disclaimer it would be approved. Showing 2 products in one commercial would be a different ask for the FDA. What you show has to be consistent with the trial results. If we could prove the results we see from the early adopters we wouldn't be where we are now. Of course there is also the obvious question of why would Dexcom want to Afrezza - Dexcom wants to show the device tracking levels, what those levels are doesn't matter. Besides that if the graph is flat people might ask why they should bother buying a Dexcom since there appears to be no need to track. The more obvious reason to me would be the fact that the Trends on the CGM's are representing the combination of both prandial Insulin, (Afrezza for example), and basal Insulin, at least in most cases. So you would almost have to do a "before afrezza, after afrezza" scenario , to show the improvement after afrezza entered the market. I do believe this before and after scenario is a possibility, especially if the Dexcom CGM's are a requirement in the Pediatric trials as they were with the trial Sanofi started. I also believe the possibility of less frequent monitoring is a real consideration for Dexcom if afrezza becomes a popular choice for mealtime Insulin. |
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Post by mnholdem on Nov 8, 2016 10:40:00 GMT -5
It would be interesting if MannKind could get Dexcom to front some $ to use the G5 Mobile CGM in an Afrezza commercial. Swinging this kind of deal would be similar to how a beverage companies pay movie studios to use their soda in a movie.
Naturally, this whole thought process is based on the presumption that MannKind will definitely be airing Afrezza commercials some day...
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Post by gtay87 on Nov 8, 2016 13:05:36 GMT -5
Didn't Edelman used to do presentations about afrezza? I haven't seen any news about his involvement recently; were those discontinued?
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Post by sayhey24 on Nov 8, 2016 20:52:11 GMT -5
Didn't Edelman used to do presentations about afrezza? I haven't seen any news about his involvement recently; were those discontinued? I think Edelman has been busy behind the scenes. I was really surprised to see him in the Dexcom commercial. We know he has been helping to define the Onduo protocol. We also know Edelman is himself, an afrezza user. "According to Dr. Edelman, who has type 1 diabetes himself, “I have used Afrezza many times myself, and the rapid off is really impressive.” Dr. Edelman also pointed out that in clinical trials, Afrezza led to reductions in hypoglycemia, though those results are not on label. - See more at: diatribe.org/companiesorganization/tcoyd |
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Post by peppy on Nov 8, 2016 21:51:20 GMT -5
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