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Post by dreamboatcruise on Mar 14, 2017 15:26:43 GMT -5
Here's your solution, advertise the crap out of this. No Needles and better A1C's. Use the company's Website as an informational piece that includes interactive dosing instructions, testimonials, a forum, and links to news clips. Rappers in the past who couldn't get record deals, sold their cassettes right out of the trunks of their cars and once people got their ears on their music, they demanded it.....and the big record labels had no other choice but to come running. MNKD, sale Afrezza to the people and not to the doctors! How many times do people here need to say that most of this IS NOT ALLOWED by the FDA. No a1c, no dosing instructions beyond what is approved by FDA, no anecdotal testimonials, no links to news clips that contain material that wouldn't be allowed as marketing material. There is a good reason that pharmaceuticals are not the wild West of supplements and diet pills.
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Post by n8 on Mar 14, 2017 15:45:05 GMT -5
Hell, here is and idea, get in contact with the Columbia drug cartel and see if they will help distribute. Seems like they have ways around the fed, and make a ton by getting the product to those who dont even need it.
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Post by kball on Mar 14, 2017 16:49:41 GMT -5
Here's your solution, advertise the crap out of this. No Needles and better A1C's. Use the company's Website as an informational piece that includes interactive dosing instructions, testimonials, a forum, and links to news clips. Rappers in the past who couldn't get record deals, sold their cassettes right out of the trunks of their cars and once people got their ears on their music, they demanded it.....and the big record labels had no other choice but to come running. MNKD, sale Afrezza to the people and not to the doctors! Also Phil Knight (started Nike) did this same thing. And he did ok too
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Post by kball on Mar 14, 2017 16:52:40 GMT -5
Here's your solution, advertise the crap out of this. No Needles and better A1C's. Use the company's Website as an informational piece that includes interactive dosing instructions, testimonials, a forum, and links to news clips. Rappers in the past who couldn't get record deals, sold their cassettes right out of the trunks of their cars and once people got their ears on their music, they demanded it.....and the big record labels had no other choice but to come running. MNKD, sale Afrezza to the people and not to the doctors! How many times do people here need to say that most of this IS NOT ALLOWED by the FDA. No a1c, no dosing instructions beyond what is approved by FDA, no anecdotal testimonials, no links to news clips that contain material that wouldn't be allowed as marketing material. There is a good reason that pharmaceuticals are not the wild West of supplements and diet pills.Is it too late to change tactics and market Afrezza as a supplement? Someone want to chime in on legal?
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Post by dreamboatcruise on Mar 14, 2017 17:04:28 GMT -5
How many times do people here need to say that most of this IS NOT ALLOWED by the FDA. No a1c, no dosing instructions beyond what is approved by FDA, no anecdotal testimonials, no links to news clips that contain material that wouldn't be allowed as marketing material. There is a good reason that pharmaceuticals are not the wild West of supplements and diet pills.Is it too late to change tactics and market Afrezza as a supplement? Someone want to chime in on legal? Put pure FDKP in a cartridge and sell it as either a weight loss solution or to "enhance male performance"... possibly both. Then we could have ads with anecdotal results. I'd be willing to put on 20 lbs so I could lose it again and have a before and after pic. That would be pretty easy for me. And of course for "male performance" you just need to find a guy willing to brag about his "performance"... of course we know that's hard to find
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Post by lojothehus on Mar 15, 2017 8:55:08 GMT -5
Here's your solution, advertise the crap out of this. No Needles and better A1C's. Use the company's Website as an informational piece that includes interactive dosing instructions, testimonials, a forum, and links to news clips. Rappers in the past who couldn't get record deals, sold their cassettes right out of the trunks of their cars and once people got their ears on their music, they demanded it.....and the big record labels had no other choice but to come running. MNKD, sale Afrezza to the people and not to the doctors! How many times do people here need to say that most of this IS NOT ALLOWED by the FDA. No a1c, no dosing instructions beyond what is approved by FDA, no anecdotal testimonials, no links to news clips that contain material that wouldn't be allowed as marketing material. There is a good reason that pharmaceuticals are not the wild West of supplements and diet pills. Are you 100% sure about what is allowed by the FDA? Anecdotal testimonies are simply people's experiences in their words; dosing instructions are already approved by the FDA; and news clips are news clips. This is NOT "marketing material," it's real life experiences captured on a website. FDA wouldn't be able to touch this.
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Post by porkini on Mar 15, 2017 9:42:00 GMT -5
Here's your solution, advertise the crap out of this. No Needles and better A1C's. Use the company's Website as an informational piece that includes interactive dosing instructions, testimonials, a forum, and links to news clips. Rappers in the past who couldn't get record deals, sold their cassettes right out of the trunks of their cars and once people got their ears on their music, they demanded it.....and the big record labels had no other choice but to come running. MNKD, sale Afrezza to the people and not to the doctors! How many times do people here need to say that most of this IS NOT ALLOWED by the FDA. No a1c, no dosing instructions beyond what is approved by FDA, no anecdotal testimonials, no links to news clips that contain material that wouldn't be allowed as marketing material. There is a good reason that pharmaceuticals are not the wild West of supplements and diet pills. Just pointing out a current creative ad out for a different product that deals with RA - calls needles on the carpet from the get-go: www.ispot.tv/ad/A4OU/xeljanz-xr-porcupine
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Post by mnholdem on Mar 15, 2017 9:48:50 GMT -5
FDA regulations (I've read them) forbids sales reps from providing trial data and studies as part of the marketing of Afrezza UNLESS the physician requests the literature OR data from a particular study is approved by the FDA and on the label. Seriously!
Most experienced sales reps know ways (symantics are hugely important) to get around this restriction of providing anecdotal/trial data. Much of the latest trial/study data could convince doctors of Afrezza's uniqueness, so it is indeed frustrating for all involved!
Data from some of the studies listed below has led to MannKind submitting the recent request to the FDA that Afrezza be reclassified as an Ultra-Rapid Acting insulin...but sales reps are NOT allowed to discuss the subject until the FDA has made its ruling.
Why is this? Well, to be frank (and as mango has recently posted), physicians are paid $millions by pharmaceutical companies to research and publish drug studies. The huge $$$ involved and potential conflict-of-interest makes it necessary for the FDA to publish rules restricting these studies from being used in marketing.
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FDA restricts sales reps from printing and providing these studies as part of any marketing activity. It sucks but, as noted above, there's a valid reason for the restriction.
You (or any doctor) can review study and trial publications at the MannKind Corporate website: www.mannkindcorp.com/research-development/publications/ 2016
Pharmacokinetic and Pharmacodynamic Properties of a Novel Inhaled Insulin J Diabetes Sci Technolo. 2016 View Publication
The Need for Faster Insulin: Problem Solved? J Diabetes Sci Technolo. 2016 View Publication
PK and PD properties of a Novel Inhaled insulin J Diabetes Sci Technolo. 2016 View Publication
Improving efficacy of inhaled TI (Afrezza) by postmeal dosing: In silico clinical trial with the University of Virginia/Padova Type 1 Diabetes Simulator Diabetes Technol Ther. 2016
Technosphere® Insulin Inhalation Powder (TI) Displays Earlier Onset and Shorter Duration than Insulin Lispro (Lispro) ADA 2016, poster 100-LB
Within-Subject Variability of Insulin Exposure and Metabolic Activity Following Replicate Doses of Technosphere® Insulin Inhalation Powder (TI) in Patients with T1DM ADA 2016, poster 102-LB
Effects of Inhaled Technosphere Insulin (TI) on the Pulmonary Function of Patients with T1D and T2D ADA 2016, poster 937-P
The Impact of Baseline Lung Function on Outcomes With Inhaled Technosphere Insulin ADA 2016, poster 973-P
Technosphere® Inhaled Human Insulin has a More Rapid Onset of Action Than Subcutaneous Insulins – Meta Analysis of Clamp Data From Three Clinical Studies ADA 2016, poster 931-P
A Population PK/PD Model of Technosphere® Insulin Administered to Healthy Subjects ADA 2016, poster 975-P
Impact of symptomatic upper respiratory tract infections on insulin absorption and action of Technosphere® Inhaled Insulin BMJ Open Diabetes Research and Car 2016; 4:e000228
Impact of Upper Respiratory Tract Infection on the Safety of Technosphere® Inhaled Insulin in Patients with Type 1 or Type 2 Diabetes AACE 2016
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Post by peppy on Mar 15, 2017 10:03:18 GMT -5
Mnholdem, remember the physician that used to frequent the board that talked about physicians waiting for the meta analysis?
What was that about? The persons nick on the board was curiousdoc.
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Post by johntherancher on Mar 15, 2017 10:10:58 GMT -5
This "not allowed by the FDA" reminds me of the definition of a Bureaucrat, i.e. Someone who has a reasonable objection to any possible solution. This definition reflects the conservative nature of the Bureaucrat who does not move out of his/her comfort zone easily. IMO, Mankind needs an aggressive approach testing the limits, whether imagined or real. Remember that if the FDA objects to published advertisements, they would "request" its removal. (See the guidelines for advertisements published by the FDA) And we don't have the time.
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Post by matt on Mar 15, 2017 10:32:37 GMT -5
However, FDA restricts sales reps from printing and providing these studies as part of any marketing activity.
All of what you said above is true, but the reason for the FDA stance goes well beyond certain companies paying doctors on the side. There is a reason for medication labels; they show the indications for which the drug has been adequately tested as has been shown to be effective. Physicians rely on such information when writing prescriptions. A few clever companies worked very hard to expand off-label usage by having friendly investigators run additional clinical studies and author papers purporting to show that the drug was safe and effective for these new indications. In some cases the studies were well done and powered to prove their point, and other times they were not. Salesmen passing out reprints of medical journal articles was used to do an end around sweep of the FDA approval process. Some of that is regulatory overreaching and some of it was a fair reaction to an actual abuse of the process. Either the labelling process has integrity or it doesn't. A lot of MNKD shareholders are clamoring for a designation as an "ultra fast-acting" insulin, but in order for that to matter FDA must first define what those words mean, and the agree that Afrezza meets that standard. If FDA is not tough on those standards, anybody can come along and claim that they too have a ultra fast insulin and thereby dilute Mannkind's potential marketing message. Regulation is always a two-edged sword.
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Post by peppy on Mar 15, 2017 11:37:44 GMT -5
However, FDA restricts sales reps from printing and providing these studies as part of any marketing activity.
All of what you said above is true, but the reason for the FDA stance goes well beyond certain companies paying doctors on the side. There is a reason for medication labels; they show the indications for which the drug has been adequately tested as has been shown to be effective. Physicians rely on such information when writing prescriptions. A few clever companies worked very hard to expand off-label usage by having friendly investigators run additional clinical studies and author papers purporting to show that the drug was safe and effective for these new indications. In some cases the studies were well done and powered to prove their point, and other times they were not. Salesmen passing out reprints of medical journal articles was used to do an end around sweep of the FDA approval process. Some of that is regulatory overreaching and some of it was a fair reaction to an actual abuse of the process. Either the labelling process has integrity or it doesn't. A lot of MNKD shareholders are clamoring for a designation as an "ultra fast-acting" insulin, but in order for that to matter FDA must first define what those words mean, and the agree that Afrezza meets that standard. If FDA is not tough on those standards, anybody can come along and claim that they too have a ultra fast insulin and thereby dilute Mannkind's potential marketing message. Regulation is always a two-edged sword. heh
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Post by mnholdem on Mar 15, 2017 11:49:56 GMT -5
However, FDA restricts sales reps from printing and providing these studies as part of any marketing activity.
[clipped Either the labelling process has integrity or it doesn't. A lot of MNKD shareholders are clamoring for a designation as an "ultra fast-acting" insulin, but in order for that to matter FDA must first define what those words mean, and the agree that Afrezza meets that standard. If FDA is not tough on those standards, anybody can come along and claim that they too have a ultra fast insulin and thereby dilute Mannkind's potential marketing message. Regulation is always a two-edged sword. Novo's new insulin is already being billed as "Ultra-Fast", even though it's only been approved for Europe and Canada and not the USA. Your point is spot on: The FDA has to define the term, because there are more companies than MannKind who are vying to separate themselves from the diabetes crowd with a new drug classification.
Novo would love nothing more than to take the wind out of Afrezza's sails (and sales), so it's good that MannKind did get a jump on Novo by having already submitted their FDA request for Afrezza to be approved for re-classification as an Ultra-Rapid Acting insulin. What exactly "ultra-rapid acting" means and, more importantly, how it must be measured will have to be determined by the FDA and published.
See: Novo Nordisk’s Ultra-Fast Rapid-Acting Insulin Fiasp Approved in Europe and Canada www.diabetesdaily.com/blog/novo-nordisks-ultra-fast-rapid-acting-insulin-fiasp-approved-in-europe-and-canada-336078/
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Post by sportsrancho on Mar 15, 2017 12:05:58 GMT -5
Touché
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Post by slugworth008 on Mar 15, 2017 12:10:19 GMT -5
[clipped Either the labelling process has integrity or it doesn't. A lot of MNKD shareholders are clamoring for a designation as an "ultra fast-acting" insulin, but in order for that to matter FDA must first define what those words mean, and the agree that Afrezza meets that standard. If FDA is not tough on those standards, anybody can come along and claim that they too have a ultra fast insulin and thereby dilute Mannkind's potential marketing message. Regulation is always a two-edged sword. Novo's new insulin is already being billed as "Ultra-Fast", even though it's only been approved for Europe and Canada and not the USA. Your point is spot on: The FDA has to define the term, because there are more companies than MannKind who are vying to separate themselves from the diabetes crowd with a new drug classification.
Novo would love nothing more than to take the wind out of Afrezza's sails (and sales), so it's good that MannKind did get a jump on Novo by having already submitted their FDA request for Afrezza to be approved for re-classification as an Ultra-Rapid Acting insulin. What exactly "ultra-rapid acting" means and, more importantly, how it must be measured will have to be determined by the FDA and published.
See: Novo Nordisk’s Ultra-Fast Rapid-Acting Insulin Fiasp Approved in Europe and Canada www.diabetesdaily.com/blog/novo-nordisks-ultra-fast-rapid-acting-insulin-fiasp-approved-in-europe-and-canada-336078/
It would be nice if Afrezza was approved in Europe or Canada -
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