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Post by sccrbrg on Sept 28, 2016 1:38:42 GMT -5
Just curious. Can MNKD apply for a label change and issue an news release to say "We have applied for a label change to label Afrezza as Ultra Rapid Insulin. Afrezza is an insulin with an outsulin component. We have gathered sufficient supporting evidence to show that Afrezza stands tour in its own class, an ultra rapid acting insulin. Please take notice that many of our competitors have wanted to speed up the action time of their insulin. Unfortunately for them and for all diabetes, their efforts had yield very limited success and they are still trying. With the ultra rapid profile of Afrezza, the good news has arrived for diabetes patients that they will now have an alternative to better manage their A1C, all without sticking themselves with a needle. Of course, there is no guarantee but we are confident that FDA will approve it on fast track, given the fact that FDA had delayed Afrezza for so long before its approval and caused so many difficulties for man(n)kind." That probably will move our PPS up. Kind of a fun thought. Just curious like I said. I'm pretty sure that violates multiple fda guidelines. Can't make those kinds of statements without fda approval - even to investors.
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Post by jonny80s on Sept 28, 2016 8:53:24 GMT -5
I'm pretty sure that Matt said, during the rodman & renshaw conference, that they plan on submitting a lable change by the end of the month (September). If someone has access to the transcript and can verify that would be great.
If October comes and goes with no label change submittal.... add it to the list of many unfillfilled timelines/actions that Mannkind management has failed to meet.
MLB postseason starts next week.... looking forward to the advertising they have planned for it.
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Post by straightly on Sept 28, 2016 16:36:47 GMT -5
Just curious. Can MNKD apply for a label change and issue an news release to say "We have applied for a label change to label Afrezza as Ultra Rapid Insulin. Afrezza is an insulin with an outsulin component. We have gathered sufficient supporting evidence to show that Afrezza stands tour in its own class, an ultra rapid acting insulin. Please take notice that many of our competitors have wanted to speed up the action time of their insulin. Unfortunately for them and for all diabetes, their efforts had yield very limited success and they are still trying. With the ultra rapid profile of Afrezza, the good news has arrived for diabetes patients that they will now have an alternative to better manage their A1C, all without sticking themselves with a needle. Of course, there is no guarantee but we are confident that FDA will approve it on fast track, given the fact that FDA had delayed Afrezza for so long before its approval and caused so many difficulties for man(n)kind." That probably will move our PPS up. Kind of a fun thought. Just curious like I said. I'm pretty sure that violates multiple fda guidelines. Can't make those kinds of statements without fda approval - even to investors. Is the application a public event? If so, a 3rd party can report, can'the it? MNKD does not have an obligation to kexpand it a secret, does it?
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Post by mnkdfann on Sept 28, 2016 16:46:11 GMT -5
Just curious. Can MNKD apply for a label change and issue an news release to say "We have applied for a label change to label Afrezza as Ultra Rapid Insulin. Afrezza is an insulin with an outsulin component. We have gathered sufficient supporting evidence to show that Afrezza stands tour in its own class, an ultra rapid acting insulin. Please take notice that many of our competitors have wanted to speed up the action time of their insulin. Unfortunately for them and for all diabetes, their efforts had yield very limited success and they are still trying. With the ultra rapid profile of Afrezza, the good news has arrived for diabetes patients that they will now have an alternative to better manage their A1C, all without sticking themselves with a needle. Of course, there is no guarantee but we are confident that FDA will approve it on fast track, given the fact that FDA had delayed Afrezza for so long before its approval and caused so many difficulties for man(n)kind." Even if everything you wrote is factually true, I can't see how MNKD dissing the FDA (in the last sentence) would motivate the FDA to fast track a new approval.
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Post by op2778 on Sept 28, 2016 16:56:15 GMT -5
Meanwhile FDA approved 1hr ago First Artificial Pancreas for T1: “This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” said the FDA’s Jeffrey Shuren about the approval.
Medtronic reportedly filed for FDA approval of the MiniMed in June and received regulatory clearance rapidly thanks to the company’s cooperation with the agency.
“Given the earlier-than-anticipated approval and the novel nature of the technology, we plan to begin shipping the MiniMed 670G system in spring of 2017,” said Hooman Hakami, executive vice president at Medtronic Diabetes, in a statement. “This timeline ensures market and manufacturing readiness, payer coverage, and appropriate training of our employees, clinicians, educators, and customers on the new system.”
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Post by prvs on Sept 28, 2016 17:37:56 GMT -5
I'm pretty sure that Matt said, during the rodman & renshaw conference, that they plan on submitting a lable change by the end of the month (September). If someone has access to the transcript and can verify that would be great. If October comes and goes with no label change submittal.... add it to the list of many unfillfilled timelines/actions that Mannkind management has failed to meet. MLB postseason starts next week.... looking forward to the advertising they have planned for it.
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Post by mnkdfann on Sept 28, 2016 19:17:43 GMT -5
MLB postseason starts next week.... looking forward to the advertising they have planned for it. They'd better knock this one out of the park, or there may be a multitude of Bronx cheers from investors. ![:)](//storage.proboards.com/forum/images/smiley/smiley.png)
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Post by mannmade on Sept 28, 2016 19:43:29 GMT -5
Meanwhile FDA approved 1hr ago First Artificial Pancreas for T1: “This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” said the FDA’s Jeffrey Shuren about the approval. Medtronic reportedly filed for FDA approval of the MiniMed in June and received regulatory clearance rapidly thanks to the company’s cooperation with the agency. “Given the earlier-than-anticipated approval and the novel nature of the technology, we plan to begin shipping the MiniMed 670G system in spring of 2017,” said Hooman Hakami, executive vice president at Medtronic Diabetes, in a statement. “This timeline ensures market and manufacturing readiness, payer coverage, and appropriate training of our employees, clinicians, educators, and customers on the new system.” So will T1's start to use AFREZZA with AP? As they did with trials in Santa Barbara? Hmmm....
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Post by agedhippie on Sept 28, 2016 20:02:38 GMT -5
Meanwhile FDA approved 1hr ago First Artificial Pancreas for T1: “This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” said the FDA’s Jeffrey Shuren about the approval. Medtronic reportedly filed for FDA approval of the MiniMed in June and received regulatory clearance rapidly thanks to the company’s cooperation with the agency. “Given the earlier-than-anticipated approval and the novel nature of the technology, we plan to begin shipping the MiniMed 670G system in spring of 2017,” said Hooman Hakami, executive vice president at Medtronic Diabetes, in a statement. “This timeline ensures market and manufacturing readiness, payer coverage, and appropriate training of our employees, clinicians, educators, and customers on the new system.” So will T1's start to use AFREZZA with AP? As they did with trials in Santa Barbara? Hmmm.... They could but probably won't. If you are on Afrezza an ordinary pump is likely just as good. The 670G is a hybrid so it still requires data from the user - food, exercise, and probably health.
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Post by mannmade on Sept 28, 2016 20:07:54 GMT -5
Exactly my point... Why count carbs, why take a prandial or bolus at meal time? Why bother replacing a pump with another pump? Why not just use a cgm + basal + AFREZZA to get similar results? For C sake, they used AFREZZA in the trials...
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