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Post by goyocafe on May 3, 2018 12:05:05 GMT -5
OH MY! The Internet has been cleansed of the article. Did The Eli Lily legal team have it pulled? Stay tuned the future will be interesting. Same bat channel same bat time. But his biography is still up on the company‘s website so that’s a great sign. www.mannkindcorp.com/david-kendall/It’s not that easy to cleanse the internet of something. Very interesting. I’m glad I kept a copy of it. I thought it was a good article but there was nothing in it in my opinion that would warrant such a drastic step as to have it completely removed from the internet. Now, by having it removed, it draws much more attention to it. Why was it removed? What was in it that caused Lilly to be so concerned? Was there a clue in it about something bigger that is coming in the future? I’m going back to read it again. I imagine that if any entity had a problem with some part of the interview, it would have been easy enough to have that part edited and/or deleted from the article. Taking strides to completely strike the article from the website implies a more sweeping issue. |
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Post by dreamboatcruise on May 3, 2018 13:08:22 GMT -5
It’s not that easy to cleanse the internet of something. Very interesting. I’m glad I kept a copy of it. I thought it was a good article but there was nothing in it in my opinion that would warrant such a drastic step as to have it completely removed from the internet. Now, by having it removed, it draws much more attention to it. Why was it removed? What was in it that caused Lilly to be so concerned? Was there a clue in it about something bigger that is coming in the future? I’m going back to read it again. I imagine that if any entity had a problem with some part of the interview, it would have been easy enough to have that part edited and/or deleted from the article. Taking strides to completely strike the article from the website implies a more sweeping issue. If you read between the lines it is evident there are aliens from a distant galaxy living among us.  |
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Post by centralcoastinvestor on May 3, 2018 14:10:58 GMT -5
If Lilly were responsible for having the article removed, then I would hazard a guess that they didn’t like the following excerpt from the article:
“I looked at where we were, and when (MannKind) came to me with this opportunity, I first and foremost thought I could come here and contribute to make a real difference in a transformative area of diabetes.
So in other words, you wanted to be on the cutting edge?
The big insulin makers are doing what they are in diabetes drugs and insulin, but the true innovation is coming from the small bio-tech space – from those at Bigfoot Biomedical, having real-time glucose information and innovating in a space that’s been tough to innovate in until recently. Afrezza’s already there, and I want to get us into the boxing ring and get the scientific and clinical chatter out there so people can truly see how this asset works.”
I imagine Lilly would not take it kindly that they were referred to as being “not on the cutting edge.” But that is hardly worth removing the article for. Would something in Dr. Kendall’s previous contract have been violated by making the statement above. I’m not seeing it.
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Post by mango on May 3, 2018 14:14:24 GMT -5
Did Mike Hoskins write the article? I'll ask him what happened to it on Twitter if that's who it was.
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Post by dreamboatcruise on May 3, 2018 14:14:35 GMT -5
If Lilly were responsible for having the article removed, then I would hazard a guess that they didn’t like the following excerpt from the article: “I looked at where we were, and when (MannKind) came to me with this opportunity, I first and foremost thought I could come here and contribute to make a real difference in a transformative area of diabetes. So in other words, you wanted to be on the cutting edge? The big insulin makers are doing what they are in diabetes drugs and insulin, but the true innovation is coming from the small bio-tech space – from those at Bigfoot Biomedical, having real-time glucose information and innovating in a space that’s been tough to innovate in until recently. Afrezza’s already there, and I want to get us into the boxing ring and get the scientific and clinical chatter out there so people can truly see how this asset works.” I imagine Lilly would not take it kindly that they were referred to as being “not on the cutting edge.” But that is hardly worth removing the article for. Would something in Dr. Kendall’s previous contract have been violated by making the statement above. I’m not seeing it. Probably has a non-disparagement clause with Lilly, but wouldn't think an implied "not on the cutting edge" would be actionable disparagement. |
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Post by centralcoastinvestor on Jun 23, 2018 10:45:23 GMT -5
Dr. Kendall has been an amazing addition to MannKind. After reading the press release today, I was impressed with how Dr. Kendall looks at existing data. The original FDA trials to get Afrezza approved showed non-inferiority with existing rapid acting analogs. Most of us at the time were bummed out because we knew Afrezza was superior but the results didn’t show it. Dr. Kendall looks at the same data and says: wait a minute, Afrezza is superior because Afrezza showed that while it is non-inferior to RAAs in controlling glucose levels it does so with 31% less hypoglycemic events. The FDA trials did in fact show superiority. With Dr. Kendall, MannKind has released the Kraken!
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Post by gareaudan on Jun 23, 2018 11:02:23 GMT -5
Dr. Kendall has been an amazing addition to MannKind. After reading the press release today, I was impressed with how Dr. Kendall looks at existing data. The original FDA trials to get Afrezza approved showed non-inferiority with existing rapid acting analogs. Most of us at the time were bummed out because we knew Afrezza was superior but the results didn’t show it. Dr. Kendall looks at the same data and says: wait a minute, Afrezza is superior because Afrezza showed that while it is non-inferior to RAAs in controlling glucose levels it does so with 31% less hypoglycemic events. The FDA trials did in fact show superiority. With Dr. Kendall, MannKind has released the Kraken! exactly ! Now Let's see what the doctors and the big investors have to say...game on. |
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Post by tomtabb on Jun 23, 2018 11:20:36 GMT -5
Dr. Kendall has been an amazing addition to MannKind. After reading the press release today, I was impressed with how Dr. Kendall looks at existing data. The original FDA trials to get Afrezza approved showed non-inferiority with existing rapid acting analogs. Most of us at the time were bummed out because we knew Afrezza was superior but the results didn’t show it. Dr. Kendall looks at the same data and says: wait a minute, Afrezza is superior because Afrezza showed that while it is non-inferior to RAAs in controlling glucose levels it does so with 31% less hypoglycemic events. The FDA trials did in fact show superiority. With Dr. Kendall, MannKind has released the Kraken! How did he look at the data differently? |
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Post by agedhippie on Jun 23, 2018 13:52:09 GMT -5
Dr. Kendall has been an amazing addition to MannKind. After reading the press release today, I was impressed with how Dr. Kendall looks at existing data. The original FDA trials to get Afrezza approved showed non-inferiority with existing rapid acting analogs. Most of us at the time were bummed out because we knew Afrezza was superior but the results didn’t show it. Dr. Kendall looks at the same data and says: wait a minute, Afrezza is superior because Afrezza showed that while it is non-inferior to RAAs in controlling glucose levels it does so with 31% less hypoglycemic events. The FDA trials did in fact show superiority. With Dr. Kendall, MannKind has released the Kraken! What Dr Kendall actually did was play with the wording. Back when the trial results were originally publish Mannkind said that Afrezza gave a significantly significant reduction in hypos, and then had to correct that and say that the results did not show a statistically significant reduction. What Dr Kendall did was change the wording to say Afrezza might reduce hypos, and not that it would. He is rely on people not parsing his words which is fair since his job is to put the best spin on things. |
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Post by akemp3000 on Jun 23, 2018 14:00:14 GMT -5
It appears the focus is no longer on fast in, fast out and no needles but on "shorter duration action profile" which has significantly less hypos. This mimics a healthy pancreas. No RAA compares. Dr. Kendall has just changed the game and will be leveraging the new Scientific Advisory Board for guidance and to help spread the word.
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Post by pguererro on Jun 23, 2018 14:03:35 GMT -5
Honestly, some of the spin I’m hearing is embarrassing. Half the A1C drop yet 31% less hypo is “a great way to relook at the data”. They’re directly correlated. I’m looking forward to reading entire STAT. Hopefully some great pearls to share. Also...Dr Kendall has been meeting with top Endos nationally for 3 mos now.
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Post by gareaudan on Jun 23, 2018 14:05:30 GMT -5
Dr. Kendall has been an amazing addition to MannKind. After reading the press release today, I was impressed with how Dr. Kendall looks at existing data. The original FDA trials to get Afrezza approved showed non-inferiority with existing rapid acting analogs. Most of us at the time were bummed out because we knew Afrezza was superior but the results didn’t show it. Dr. Kendall looks at the same data and says: wait a minute, Afrezza is superior because Afrezza showed that while it is non-inferior to RAAs in controlling glucose levels it does so with 31% less hypoglycemic events. The FDA trials did in fact show superiority. With Dr. Kendall, MannKind has released the Kraken! What Dr Kendall actually did was play with the wording. Back when the trial results were originally publish Mannkind said that Afrezza gave a significantly significant reduction in hypos, and then had to correct that and say that the results did not show a statistically significant reduction. What Dr Kendall did was change the wording to say Afrezza might reduce hypos, and not that it would. He is rely on people not parsing his words which is fair since his job is to put the best spin on things. of course he said might and not would. Their is not one pills or treatment that has 100% chance of doing what it is suppose to do. Their is always some peoples that will react badly to the treatment no matter how good it is. It is not a matter of words but a matter of numbers and the numbers are there. You are trying too hard to find a bad turn to this. |
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Post by mytakeonit on Jun 23, 2018 14:46:42 GMT -5
You all are saying 31% reduced hypoglycemic events .. didn't the report say 41% ??
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Post by peppy on Jun 23, 2018 14:54:51 GMT -5
Honestly, some of the spin I’m hearing is embarrassing. Half the A1C drop yet 31% less hypo is “a great way to relook at the data”. They’re directly correlated. I’m looking forward to reading entire STAT. Hopefully some great pearls to share. Also...Dr Kendall has been meeting with top Endos nationally for 3 mos now. Where are you seeing half the HbA1c drop? Half the A1C drop yet 31% less hypo is “a great way to relook at the data”. added; Title: Total and Severe Hypoglycemia is Reduced With Use of Inhaled Technosphere® Insulin (AFREZZA®) Relative to Insulin Aspart in Type 1 Diabetes Presenter: Lawrence Blonde Highlights: Compared to insulin aspart: Use of Afrezza significantly lowers the rate of hypoglycemia in Type 1 diabetes while providing similar or better glycemic control (54.1 events per subject vs. 78.2 events per subject, a reduction of 31%) On average, 26% lower rates of hypoglycemia were observed with Afrezza across the range of HbA1c levels, allowing the same degree of glycemic control with less hypoglycemia than insulin aspart. For example,
a patient with an HbA1c of 8.0% on insulin aspart would experience the same rate of hypoglycemia (12.2 events per month) as a patient on Afrezza with an HbA1c of 6.8% (ΔHbA1c = -1.2%)
Alternatively, patients with HbA1c of 6.8% on Afrezza would be estimated to experience 4 fewer hypoglycemic events per month than a similar patient on insulin aspart Conclusion: Use of Afrezza in a multi-dose insulin regimen may permit treatment intensification to be achieved with less hypoglycemia. Switching to Afrezza may also benefit patients already at goal by reducing the frequency of hypoglycemia events. See it; (ΔHbA1c = -1.2%) read change in HbA1c - 1.2% |
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Post by agedhippie on Jun 23, 2018 15:51:06 GMT -5
What Dr Kendall actually did was play with the wording. Back when the trial results were originally publish Mannkind said that Afrezza gave a significantly significant reduction in hypos, and then had to correct that and say that the results did not show a statistically significant reduction. What Dr Kendall did was change the wording to say Afrezza might reduce hypos, and not that it would. He is rely on people not parsing his words which is fair since his job is to put the best spin on things. of course he said might and not would. Their is not one pills or treatment that has 100% chance of doing what it is suppose to do. Their is always some peoples that will react badly to the treatment no matter how good it is. It is not a matter of words but a matter of numbers and the numbers are there. You are trying too hard to find a bad turn to this. No, the numbers are not there or the results would be statistical significant. This is science and either the data is there to support the statement or it isn't. Lets read what Mannkind themselves said - focus on the last sentence: Significantly less total hypoglycemia was observed in the AFREZZA-Gen2 group (9.80 events per subject-month) compared to the insulin aspart group (13.97 events per subject-month; p<0.0001). The event rate of severe hypoglycemia was also lower in the AFREZZA-Gen2 group (8.05 events per 100 subject-months) than in the insulin aspart group (14.45 events per 100 subject-months); however, this difference was not statistically significant (p=0.1022).
What that says is that if you reran the test the results could be reversed. That is why he says it MAY reduce hypos, equally it MAY increase them. Either way we will see in the next couple of weeks as the NRx numbers will show how the doctors read it which is what matters. |
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