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Post by agedhippie on Jun 13, 2020 13:55:33 GMT -5
The HbA1c was a secondary result in a failed study without a comparator arm so that study goes nowhere. To put it in context Dexcom did a study using CGMs with Type 2s and got exactly the same reduction just by using a CGM. Dexcom are going to look at this study and say that on those grounds Afrezza made zero contribution to the HbA1c reduction. ... With CGMs there is no need for an additional comparator arm. The comparator arm are the same PWDs. With CGMs you know exactly how they were performing prior to the introduction of the changed medication - in this case afrezza. In this study - prior to afrezza you had these PWDs on the CGM and RAA. In this study they took 25 people, measured their baseline with the RAA and CGM and then switched them to afrezza. If the previous Dexcom studies are correct these PWDs should have already seen some A1c benefit prior to afrezza since they were already using the CGM with the RAA. ... Using a CGM before the trial is not a selection criteria, and since they are Type 2 diabetics who have difficultly getting cover for CGMs it's unlikely were already using a Dexcom. Especially since the protocol requires the collection of the CGMs at the end of the trial. The Diamond study on Type 2 diabetics showed a 0.8 reduction in HbA1c from adding a Dexcom to standard RAA vs. a 0.76 reduction in a Dexcom plus Afrezza in this study. This is why a control arm is a good idea because the only way to disprove that is to be able to point at the control arm for comparison. Absent a control arm then the outcome will get compared to Diamond.
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Post by agedhippie on Jun 13, 2020 14:04:03 GMT -5
The HbA1c was a secondary result in a failed study without a comparator arm so that study goes nowhere. To put it in context Dexcom did a study using CGMs with Type 2s and got exactly the same reduction just by using a CGM. Dexcom are going to look at this study and say that on those grounds Afrezza made zero contribution to the HbA1c reduction. This is the bit Shawn and I kept hammering but people don't seem to want to hear. The second dose is a big deal because it doubles the number of times you have to think about and deal with your diabetes. That seriously matters. “It doubles the amount of times you have to think about and deal with your diabetes” Haha,,, thats funny!! People with diabetes are NEVER not thinking about and dealing with their diabetes. And my wife has a 5.6 A1c with incredible TiR, and is living like a non diabetic. When is someone other than her going to figure out how to use this miracle drug!?!?!. I am painfully aware of the realities of having Type 1, that moment when you feel slightly strange and you wonder if it's your levels or normal. Wondering if you CGM is accurate at the moment. Compression lows waking you up in the night. There are a ton of things. That's why adding more is a lousy option. I am glad that it works so well for your wife. However, that doesn't mean it will work equally well for all diabetics (or the outcomes from the trials would be far better) which is why Type 1 diabetics seldom criticize other peoples treatment choices. They are well aware that one size does not fit all despite what the medical world thinks (another sore point).
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Post by longliner on Jun 13, 2020 15:20:52 GMT -5
Why would ANYONE spend so much effort on the stock board of a Company that they have no investment in? Each post a negative bent on all news related to the product and Company? Go long!
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Post by nylefty on Jun 13, 2020 16:15:48 GMT -5
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Post by cretin11 on Jun 13, 2020 18:36:01 GMT -5
Why would ANYONE spend so much effort on the stock board of a Company that they have no investment in? Each post a negative bent on all news related to the product and Company? Go long! Good question longliner. That’s Aged’s business, but it would be nice if one day he saw fit to go long. I think he would tell us and that it would be a well reasoned decision.
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Post by longliner on Jun 13, 2020 20:22:32 GMT -5
Why would ANYONE spend so much effort on the stock board of a Company that they have no investment in? Each post a negative bent on all news related to the product and Company? Go long! Good question longliner. That’s Aged’s business, but it would be nice if one day he saw fit to go long. I think he would tell us and that it would be a well reasoned decision. He's a smart poster, with much information to share, actually, he's one of my favorite. If I was to say negative things about the product and company I had invested in, I would short it prior to maligning it. There are many negative points about each of my investments, but as a long investor on a public message board to add to the negative noise makes no sense? Only shorts, paid basher's and accumulators would spend their time in this action as it might prove of value to them. At five, he's with us!
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Post by sportsrancho on Jun 13, 2020 21:48:31 GMT -5
The stock and the company are not out of the woods yet that’s why he isn’t long. It’s OK to take a risk, it’s also ok not to.
Opposing opinions are what stock boards are for. I used to think anybody that talked negatively didn’t have any respect for my money. But I think we’ve come along way since then, and evolved to the point where people can give their opinions good or bad ...that’s how you come up with solutions.
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Post by cretin11 on Jun 13, 2020 21:51:24 GMT -5
Good question longliner. That’s Aged’s business, but it would be nice if one day he saw fit to go long. I think he would tell us and that it would be a well reasoned decision. He's a smart poster, with much information to share, actually, he's one of my favorite. If I was to say negative things about the product and company I had invested in, I would short it prior to maligning it. There are many negative points about each of my investments, but as a long investor on a public message board to add to the negative noise makes no sense? Only shorts, paid basher's and accumulators would spend their time in this action as it might prove of value to them. At five, he's with us! My counter is that our posts on this message board have absolutely zero effect on the share price movement. I’m long MNKD and have no problem pointing out negative issues with the company’s execution when I believe it to be so. First of all, I have no intention or reason to “spin” anything. Secondly, even if I did try to manipulate the share price with my posts it would be folly, because nobody is making investment decisions based on my posts or anyone else’s posts here. Nor should they. This is supposed to be an open forum for honest opinions; good, bad, informed or even just wishful thinking.
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Post by longliner on Jun 13, 2020 21:59:28 GMT -5
He's a smart poster, with much information to share, actually, he's one of my favorite. If I was to say negative things about the product and company I had invested in, I would short it prior to maligning it. There are many negative points about each of my investments, but as a long investor on a public message board to add to the negative noise makes no sense? Only shorts, paid basher's and accumulators would spend their time in this action as it might prove of value to them. At five, he's with us! My counter is that our posts on this message board have absolutely zero effect on the share price movement. I’m long MNKD and have no problem pointing out negative issues with the company’s execution when I believe it to be so. First of all, I have no intention or reason to “spin” anything. Secondly, even if I did try to manipulate the share price with my posts it would be folly, because nobody is making investment decisions based on my posts or anyone else’s posts here. Nor should they. This is supposed to be an open forum for honest opinions; good, bad, informed or even just wishful thinking. Did you really say zero?? Always and never tend to make for suspect tales.🤣
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Post by longliner on Jun 13, 2020 22:10:59 GMT -5
The stock and the company are not out of the woods yet that’s why he isn’t long. It’s OK to take a risk, it’s also ok not to. Opposing opinions are what stock boards are for. I used to think anybody that talked negatively didn’t have any respect for my money. But I think we’ve come along way since then, and evolved to the point where people can give their opinions good or bad ...that’s how you come up with solutions. Yeah, he's 4000 + posts into not long. That would make Sach's proud.😎 Or, in your case give you solutions.
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Post by cretin11 on Jun 14, 2020 3:11:48 GMT -5
My counter is that our posts on this message board have absolutely zero effect on the share price movement. I’m long MNKD and have no problem pointing out negative issues with the company’s execution when I believe it to be so. First of all, I have no intention or reason to “spin” anything. Secondly, even if I did try to manipulate the share price with my posts it would be folly, because nobody is making investment decisions based on my posts or anyone else’s posts here. Nor should they. This is supposed to be an open forum for honest opinions; good, bad, informed or even just wishful thinking. Did you really say zero?? Always and never tend to make for suspect tales.🤣 Agree with you about using the words “always” and “never”. But I am confident in my statement above, that none of your posts or my posts on this message board have moved this stock’s share price. If your and my posts were deleted off this board and had never occurred, the share price would be exactly where it is today. Same for aged’s posts. Obviously it can’t be proved or disproved. If we held some position with the company I wouldn’t say that. For example, when MC used to post, then he certainly had the ability to alter the price potentially with a post. Another example is when years ago somebody made an honest mistake and mistyped the script report numbers on a Friday morning. The share price had a big bounce up at open (I fell for it and bought shares too). Direct effect from a post, though a mistake. And once it was cleared up, price came back down and didn’t take long to settle back (down to what would be a split adjusted share price of around 7 or 8 dollars, IIRC). But in general, posts by “regular folks” here don’t move the share price IMO.
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Post by slugworth008 on Jun 14, 2020 5:59:37 GMT -5
DXCM cares if it will add sales of their devices. You might have a person using Afrezza and not using a CGM. A partnership will enhance both parties. The other issue - CGM users will realize how slow their RAAs work and when they learn about how fast Afrezza works.....it will be a no brainer! The speed of action is just one parameter. That is offset by the need to dose twice as often. You have to look at the whole picture. Few people will move for speed of action alone, what matters is a material improvement with no extra work. So you're saying that inhaling twice is going to put people off?
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Post by sayhey24 on Jun 14, 2020 7:50:18 GMT -5
Aged - what do you think? They spun the press release and do not talk about it as a "failed" study. Instead they BOLD A1c reduction. They made it sound like a huge success. This statement from Kipnes also seems to contradict your argument about 2nd dosing being a burden "improved clinical outcomes were possible, and patients reported less burden from their diabetes treatment". I am not sure the relationship between Kipnes and Ralph DeFronzo except they are from the same town. I do remember Al getting into it with Ralph over afrezza and the use of afrezza as a frontline T2 treatment. I also remember Ralph finally admitting the biggest waste of time in T2 treatment was the use of metformin. It would be nice but not likely Ralph finally realizes Al was right. www.globenewswire.com/news-release/2020/06/13/2047727/0/en/Investigator-Initiated-Study-Shows-Switching-to-Afrezza-Improves-Glucose-Control-with-No-Additional-Hypoglycemia-in-T2DM.htmlThe lead author, Mark Kipnes, MD (Diabetes and Glandular Disease Clinic, San Antonio, Texas) presented clinical data from an investigator-initiated observational “switch” study that evaluated quality of life and glucose control in patients with type 2 diabetes previously treated with injected mealtime insulin. Following conversion to Afrezza, patients were followed for 14 weeks, and glucose control (measured by both A1C and glucose time in range), rates of hypoglycemia and quality of life were assessed. Study subjects experienced a significant (0.8%) reduction in A1C levels at the end of the 14-week treatment period after switching from their injected mealtime insulin to Afrezza. Subjects maintained 66-69% “time in range” (time with glucose values in the range of 70-180 mg/dL) and reduced the time spent with glucose <90 mg/dL. Afrezza therapy resulted in a significant improvement in diabetes quality of life scores. “This study shows that Afrezza treatment—combined with the use of continuous glucose monitoring—can improve overall glucose control while maintaining time in range. Importantly, the study also demonstrates a reduction in blood glucose levels without additional hypoglycemia,” stated Dr. Kipnes. “In addition, after switching to Afrezza, these individuals reported an improvement in quality of life measures. This study demonstrates that by rapidly adjusting Afrezza doses, improved clinical outcomes were possible, and patients reported less burden from their diabetes treatment.”
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Post by agedhippie on Jun 14, 2020 8:54:32 GMT -5
The speed of action is just one parameter. That is offset by the need to dose twice as often. You have to look at the whole picture. Few people will move for speed of action alone, what matters is a material improvement with no extra work. So you're saying that inhaling twice is going to put people off? Yes. Both Shawn and I have said this in the past.
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Post by agedhippie on Jun 14, 2020 9:06:30 GMT -5
Aged - what do you think? They spun the press release and do not talk about it as a "failed" study. Instead they BOLD A1c reduction. They made it sound like a huge success. This statement from Kipnes also seems to contradict your argument about 2nd dosing being a burden "improved clinical outcomes were possible, and patients reported less burden from their diabetes treatment". I am not sure the relationship between Kipnes and Ralph DeFronzo except they are from the same town. I do remember Al getting into it with Ralph over afrezza and the use of afrezza as a frontline T2 treatment. I also remember Ralph finally admitting the biggest waste of time in T2 treatment was the use of metformin. It would be nice but not likely Ralph finally realizes Al was right. www.globenewswire.com/news-release/2020/06/13/2047727/0/en/Investigator-Initiated-Study-Shows-Switching-to-Afrezza-Improves-Glucose-Control-with-No-Additional-Hypoglycemia-in-T2DM.htmlThe lead author, Mark Kipnes, MD (Diabetes and Glandular Disease Clinic, San Antonio, Texas) presented clinical data from an investigator-initiated observational “switch” study that evaluated quality of life and glucose control in patients with type 2 diabetes previously treated with injected mealtime insulin. Following conversion to Afrezza, patients were followed for 14 weeks, and glucose control (measured by both A1C and glucose time in range), rates of hypoglycemia and quality of life were assessed. Study subjects experienced a significant (0.8%) reduction in A1C levels at the end of the 14-week treatment period after switching from their injected mealtime insulin to Afrezza. Subjects maintained 66-69% “time in range” (time with glucose values in the range of 70-180 mg/dL) and reduced the time spent with glucose <90 mg/dL. Afrezza therapy resulted in a significant improvement in diabetes quality of life scores. “This study shows that Afrezza treatment—combined with the use of continuous glucose monitoring—can improve overall glucose control while maintaining time in range. Importantly, the study also demonstrates a reduction in blood glucose levels without additional hypoglycemia,” stated Dr. Kipnes. “In addition, after switching to Afrezza, these individuals reported an improvement in quality of life measures. This study demonstrates that by rapidly adjusting Afrezza doses, improved clinical outcomes were possible, and patients reported less burden from their diabetes treatment.” ... and they failed to hit the primary target which was better TIR. Then they got a worse reduction adding Afrezza and a Dexcom than Dexcom did in a far bigger study (Diamond) where they added just a CGM. Did they drop in A1c relate to the CGM, or the CGM and Afrezza? You cannot say with a control which wasn't there because A1c reduction was not the purpose of the trial. So yes, that press release is spin (which is after all almost the definition of a press release!) The study is a washout. I don't fault them for this as you have to work with what you have, but don't expect any change from this. The QoL improvement is good, but that would need to be expanded to a larger group and a longer timeline before it is clear whether that is an actual improvement or just the novelty. Then of course there is the fact that they lost 4 out of 25 participants - that's not good. For adoption the second study on dosing is far more important since it is the start of the work to get the dosing on the label adjusted which is critical if you want to improve retention.
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