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Post by peppy on Apr 15, 2017 7:46:59 GMT -5
Is mankind coming out of the dark ages yet? Do you mean mankind or MannKind? No to MannKind. Mankind is more complicated... Our enormous population seems to have resulted in a large number of geniuses, but unfortunately HUGE numbers of knuckle draggers. The situation in the Middle East (and elsewhere) suggests the "dark ages" are live and well... Praying to the gods doesn't seem to help. I'm still kind of hoping for human genetic modification to solve the problem. In other words, become less human...
Some days the zombie apocalypse looks appealing. But I'm rooting for AI overlords.Becareful what you ask for? Chemtrails Analysis: New Discoveries 1/2 www.youtube.com/watch?v=wjzkEiO6AAc
I meant Mankind and dark ages: A play of words on Mannkind. a. Afrezza Dosing was only changed approx. every 6 weeks, and not flexible dosing depending on meal
b. No CGM’s allowed
c. Time in Zone not measured
d. Patient Quality of Life not measured
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Post by radgray68 on Apr 15, 2017 10:32:23 GMT -5
Truthfully, with how bad the trials were set up, its amazing Afrezza got FDA approval at all. It's a testament to how well Afrezza works that it was approved in spite of incredible hurdles set up in the clinical protocols. I just wish Al Mann was still alive to provide the financial assistance needed to get across the finish line. He could see how well Afrezza would work 15 years ago. Imagine having that kind of vision. Imagine how frustrating it must have been for Al Mann to watch the FDA fumble around with Afrezza? I'm thinking it went down kind of like 2001 a space odyssey where the monkeys discovered tools. Only, in the case of Afrezza, the fine people at the FDA couldn't (or deliberately wouldn't) stop throwing feces at one another long enough to PICK UP THE GD STICK! It must have been so maddening. Ever try explaining the features of an iPhone to the elderly? My dad had me screaming inside my own head because he just..didn't get it. Yeah, I'm pretty sure Al must have had his screaming-inside-your-head moments. He took away the 2 biggest complaints/barriers to treatment of diabetes, needles and long tail, and what happens? They don't like it because it's different? With these kinds of barriers to advancement in medicine, no wonder so many believe mankind is doomed. The FDA might as well have beat Al to death with a stick like a bunch of monkeys. JMHO, of course.
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Post by centralcoastinvestor on Apr 15, 2017 10:48:23 GMT -5
Truthfully, with how bad the trials were set up, its amazing Afrezza got FDA approval at all. It's a testament to how well Afrezza works that it was approved in spite of incredible hurdles set up in the clinical protocols. I just wish Al Mann was still alive to provide the financial assistance needed to get across the finish line. He could see how well Afrezza would work 15 years ago. Imagine having that kind of vision. Imagine how frustrating it must have been for Al Mann to watch the FDA fumble around with Afrezza? I'm thinking it went down kind of like 2001 a space odyssey where the monkeys discovered tools. Only, in the case of Afrezza, the fine people at the FDA couldn't (or deliberately wouldn't) stop throwing feces at one another long enough to PICK UP THE GD STICK! It must have been so maddening. Ever try explaining the features of an iPhone to the elderly? My dad had me screaming inside my own head because he just..didn't get it. Yeah, I'm pretty sure Al must have had his screaming-inside-your-head moments. He took away the 2 biggest complaints/barriers to treatment of diabetes, needles and long tail, and what happens? They don't like it because it's different? With these kinds of barriers to advancement in medicine, no wonder so many believe mankind is doomed. The FDA might as well have beat Al to death with a stick like a bunch of monkeys. JMHO, of course. I was a shareholder during all of that CRL mess. Al's original plan was to target T1s only and start small. If the FDA had approved Afrezza the first time without the CRLs, then MannKind would have had plenty of money to figure out how to market it to PWD and complete all the followup studies. AND Alfred Mann would have been alive to see his dream come to pass. It's infuriating how poorly the FDA treated MannKind and Afrezza.
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Post by centralcoastinvestor on Apr 15, 2017 10:52:28 GMT -5
After the 2nd CRL MNKD management had to play nice with the FDA to get the 171/175 trial protocols approved rapidly...what other choice did they have but to accept the hand they were dealt which was to have them dose like RAA (way too early) 15 minutes or whatever it was before the meal. Even with the poor dose timing Afrezza proved non-inferior to RAA and the stooges at the FDA couldn't wiggle out of that. During the AdComm one of the the FDA scientists tried to make the case that the lack of long tail of Afrezza versus RAA was an indication of inferiority. Go figure. MNKD has had so much sand kicked in its face over so many years it's no wonder it is where it is today. Well stated. I agree with everything you say here.
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Post by bioexec25 on Apr 15, 2017 11:16:19 GMT -5
Agree with most as well CCI with one exception. Beyond R&D it takes big Clinical & Regulatory chops to get trials structured properly for desired outcomes. Best way to predict the future is to help create it. Either the proper protocol & setup structure wasn't known or they just didn't have the experience & FDA relationships to get it done. I'm long long but I don't know why this never got setup for more immediate commercial success from dosing to classification. Unfortunately as we are witnessing it is resulting in catastrophic commercial failure (so far).
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Post by lakers on Apr 15, 2017 11:31:00 GMT -5
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Post by cjm18 on Apr 15, 2017 11:49:39 GMT -5
Expensive the trials are Al said. Hopefully the planned studies are included in the 10m burn rate. Where is mannkind going to get the money without giving away some of the company for pennies?
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Post by compound26 on Apr 16, 2017 22:01:04 GMT -5
I have not been to any JDRF and TCOYD events that Mannkind participated. So have no idea on how such event actually goes.
How about Mannkind doing something different to attract more attention and participation? I recall someone on this board has mentioned the idea of flying Matt B. (who, by the way is in Australia) out to do the coke challenge live.
Is it possible that on such an event, Mannkind doing a live coke challenge, whereby, one or more Afrezza users will drink a cup of coke and shows his/her CGM lines every 5/10 minutes. Mannkind can invite others, whether diabetic or not, to participate in the challenge and drink a cup of coke at the same time with the afrezza users and monitor and show his/her BG levels every 5/10 minutes.
Whoever has the best BG level at 30/60 minutes will receive a nominal prize, say a $100 gift card or a similar amount donation in his/her name to JDRF/TCOYD and a small afrezza coke challenge trophy (and a cute aferzza dreamboat as a souvenir, with an outsulin mascot toy for the kids if applicable)!
Kids will love to see that!
Mannkind can repeat such challenge in every two/three hours in each such event. I would image this will be crowd gathering.
Also, in such a challenge, it will not be important whether the afrezza user(s) in such a case actually have the lowest BG levels or win the challenge. As long as this help PWDs to see aferzza's impressive ability to stop BG from rising after a cup of afrezza, this will serve the purpose of getting the word out. So it is not important who the winner is.
What do you guys think?
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Post by dreamboatcruise on Apr 17, 2017 4:05:10 GMT -5
I have not been to any JDRF and TCOYD events that Mannkind participated. So have no idea on how such event actually goes. How about Mannkind doing something different to attract more attention and participation? I recall someone on this board has mentioned the idea of flying Matt B. (who, by the way is in Australia) out to do the coke challenge live. Is it possible that on such an event, Mannkind doing a live coke challenge, whereby, one or more Afrezza users will drink a cup of coke and shows his/her CGM lines every 5/10 minutes. Mannkind can invite others, whether diabetic or not, to participate in the challenge and drink a cup of coke at the same time with the afrezza users and monitor and show his/her BG levels every 5/10 minutes. Whoever has the best BG level at 30/60 minutes will receive a nominal prize, say a $100 gift card or a similar amount donation in his/her name to JDRF/TCOYD and a small afrezza coke challenge trophy (and a cute aferzza dreamboat as a souvenir, with an outsulin mascot toy for the kids if applicable)! Kids will love to see that! Mannkind can repeat such challenge in every two/three hours in each such event. I would image this will be crowd gathering. Also, in such a challenge, it will not be important whether the afrezza user(s) in such a case actually have the lowest BG levels or win the challenge. As long as this help PWDs to see aferzza's impressive ability to stop BG from rising after a cup of afrezza, this will serve the purpose of getting the word out. So it is not important who the winner is. What do you guys think? I am not diabetic. But at my age, I know I could easily be beat by someone with Afrezza. No questions asked, I'd bet against myself if faced with a seasoned Afrezza user with a CGM or Libre. Sadly, as an investor, they aren't allowed to do that.
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Post by peppy on Apr 17, 2017 10:42:49 GMT -5
I have not been to any JDRF and TCOYD events that Mannkind participated. So have no idea on how such event actually goes. How about Mannkind doing something different to attract more attention and participation? I recall someone on this board has mentioned the idea of flying Matt B. (who, by the way is in Australia) out to do the coke challenge live. Is it possible that on such an event, Mannkind doing a live coke challenge, whereby, one or more Afrezza users will drink a cup of coke and shows his/her CGM lines every 5/10 minutes. Mannkind can invite others, whether diabetic or not, to participate in the challenge and drink a cup of coke at the same time with the afrezza users and monitor and show his/her BG levels every 5/10 minutes. Whoever has the best BG level at 30/60 minutes will receive a nominal prize, say a $100 gift card or a similar amount donation in his/her name to JDRF/TCOYD and a small afrezza coke challenge trophy (and a cute aferzza dreamboat as a souvenir, with an outsulin mascot toy for the kids if applicable)! Kids will love to see that! Mannkind can repeat such challenge in every two/three hours in each such event. I would image this will be crowd gathering. Also, in such a challenge, it will not be important whether the afrezza user(s) in such a case actually have the lowest BG levels or win the challenge. As long as this help PWDs to see aferzza's impressive ability to stop BG from rising after a cup of afrezza, this will serve the purpose of getting the word out. So it is not important who the winner is. What do you guys think? I love it. Show them. We are not blind, we can see. I love it.
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Post by compound26 on Apr 17, 2017 10:49:18 GMT -5
Afrezza User Survey.
Another thing that I think one of the Afrezza users can do is to do an Afrezza user survey. Per my personal count, as of today, I can identify about 70 people (instead of the often quoted a dozen or so active Afrezza users that various people often claiming) who have shared in social media their (or their family member’s) experience on afrezza. If I dig a little bit deeper, it is likely that I may be able to identify around 100 of those users who have shared in social media their (or their family member’s) experience on afrezza.
In view of this, can we do a survey of these users, asking them to provide the following information:
a. Is he/she still on afrezza;
b. If not, what is the main reason for he/she to drop afrezza (e.g., titration issues, dosage issues, insurance coverage issues, doctors’ noncooperation, side effects, etc., this could help Mannkind’s marketing decisions and efforts);
c. If yes, how long he/she has stayed on afrezza;
d. His/her A1Cs before he/she started using afrezza;
e. His/her A1Cs after he/she started using afrezza;
f. How much units of Afrezza he/she uses per day/week/month;
g. Typical dosage for a breakfast/lunch/dinner;
h. Typical dosing time for a breakfast/lunch/dinner;
i. How he/she dose for fatty food like a pizza;
j. What he/she likes afrezza the best;
k. What is the main challenge in using afrezza;
l. Has he/she felt life quality improved since suing afrezza and if so, in what aspects;
m. Has he/she experienced any discomfort or side effects;
n. What is he/her cost per month on Afrezza (and on RAA if he/she used RAA before adopting afrezza);
o. What suggestion of improvement he/she has towards Mannkind regarding afrezza.
In effect, this will be a survey like what AfrezzaUser (Sam Finta) has done with respect to the pioneer group of afrezza users, but with a relatively larger sample size, probably with a sample group of around 50-100 people. This definitely will not count as serious medical report or journal work, however, it will definitely provide some insight to Mannkind and prospective afrezza users and garner some attention among the PWDs.
This will be a good project for someone like Dr. Steven Adelman, Amy Tenderich, Mike Hoskins, Daniele Hargenrader, Sam Finta and Robin Jarrell, if any of them will be interested in taking up such a project. Alternatively, I would imagine someone like liane, who I recall is a registered nurse, will also be a good candidate to take up such a project?
To make the survey easier to complete, perhaps we can devise a web form and send the survey target a link to the web form, where they can just type their answers and click submit.
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Post by compound26 on Apr 17, 2017 15:51:11 GMT -5
I have not been to any JDRF and TCOYD events that Mannkind participated. So have no idea on how such event actually goes. How about Mannkind doing something different to attract more attention and participation? I recall someone on this board has mentioned the idea of flying Matt B. (who, by the way is in Australia) out to do the coke challenge live. Is it possible that on such an event, Mannkind doing a live coke challenge, whereby, one or more Afrezza users will drink a cup of coke and shows his/her CGM lines every 5/10 minutes. Mannkind can invite others, whether diabetic or not, to participate in the challenge and drink a cup of coke at the same time with the afrezza users and monitor and show his/her BG levels every 5/10 minutes. Whoever has the best BG level at 30/60 minutes will receive a nominal prize, say a $100 gift card or a similar amount donation in his/her name to JDRF/TCOYD and a small afrezza coke challenge trophy (and a cute aferzza dreamboat as a souvenir, with an outsulin mascot toy for the kids if applicable)! Kids will love to see that! Mannkind can repeat such challenge in every two/three hours in each such event. I would image this will be crowd gathering. Also, in such a challenge, it will not be important whether the afrezza user(s) in such a case actually have the lowest BG levels or win the challenge. As long as this help PWDs to see aferzza's impressive ability to stop BG from rising after a cup of afrezza, this will serve the purpose of getting the word out. So it is not important who the winner is. What do you guys think? I am not diabetic. But at my age, I know I could easily be beat by someone with Afrezza. No questions asked, I'd bet against myself if faced with a seasoned Afrezza user with a CGM or Libre. Sadly, as an investor, they aren't allowed to do that. dreamboatcruise Can you elaborate on why Mannkind can not do something like this, if they do not make any claim that is not supported by the label?
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Post by compound26 on Apr 17, 2017 16:16:39 GMT -5
What a new study/label change can mean to Afrezza?Let’s take a look at Minimed’s history and see if we can learn from there. Pursuant to this article (published in 1995), MiniMed, which has been selling the insulin pump since 1985, has long had trouble making money, in part due to large amounts spent on research into new systems of diabetes treatment. Granted, MiniMed's annual sales have almost tripled to $36.3 million in 1994 from $12.5 million in 1990, but in 1994, MiniMed lost $900,000, compared to a loss of $1.6 million in 1993. However, in the second quarter ending June 30 of this year, the company reported a profit of $101,000. ......... “ But a National Institutes of Health study published in September, 1993, in the New England Journal of Medicine found that tight control of blood sugars such as that achieved by very frequent injections of insulin--say four times a day--or infusion pumps can delay and slow progression of several of the most serious long-term complications of diabetes, such as blindness. This was a watershed finding for the treatment of diabetes and for MiniMed, which provided the pumps used in the study. "It was a landmark study," said Dr. David Kayne, insulin pump director at the diabetes care center at Encino/Tarzana Regional Medical Center. Physicians had long speculated that a continuous flow of the hormone insulin is healthier than injections of longer-acting insulin.”
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Post by dreamboatcruise on Apr 17, 2017 16:20:50 GMT -5
I am not diabetic. But at my age, I know I could easily be beat by someone with Afrezza. No questions asked, I'd bet against myself if faced with a seasoned Afrezza user with a CGM or Libre. Sadly, as an investor, they aren't allowed to do that. dreamboatcruise Can you elaborate on why Mannkind can not do something like this, if they do not make any claim that is not supported by the label? FDA requires that any marketing be balanced and include the adverse effects that occurred in the trials. Small uncontrolled demonstration of use such as what you are suggesting I believe is simply considered incompatible with the requirement to present balanced marketing material... i.e. how do you represent bronchial spasms, hypos, etc. in that sort of setting. I'm sure you've seen many TV ads for other drugs, as it is hard to watch TV without seeing them. The reason they are formatted as they are is because of the requirements of the FDA, not because all the pharma companies hire terrible ad firms. If you pay close attention to the ads you'll see that they don't ever have someone talking about the wonderful results they got. Even when they have an actor play a patient they will have their script say something like "I went to my doctor and my doctor told me xyz MAY help with my... ". It would be great if they could figure out some way of enabling real patient results being shared. Maybe they could organize meetings for people interested in Afrezza and existing Afrezza users. Though if MNKD had any role in organizing such an event, it may still fall afoul of the FDA.
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Post by sportsrancho on Apr 17, 2017 16:24:18 GMT -5
articles.latimes.com/2001/may/31/business/fi-4587Medtronic said it will pay $48 a share for MiniMed, a 9.1% premium over Tuesday's closing stock price, but a near doubling of the $25-per-share price seen in April, before rumors of a MiniMed sale began circulating.
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