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Post by radgray68 on Oct 26, 2016 20:35:32 GMT -5
This will be my first thread over here since giving up on Yahoo several months ago. I'm a little rusty, but here it goes:
On Gray Areas
I've played by the rules my entire life. Honesty is the best policy, follow the golden rule, work hard, play fair, don't cheat, look both ways before crossing...you get the gist. I used to think staying above board was what separated me from the "bad guys." I believe that the straight-forward, honest approach has been taken by Mannkind management in getting Afrezza to patients. Now, I'm afraid that same nice, noble approach may be part of the reason Mannkind is finishing like nice guys unfortunately tend to finish, dead last. The global drug market is a pool of sharks is it not? And the Wall Street crowd seems to have no patience for nice. So, I say, before Afrezza disappears forever into the annuls of history, lets get a little dirty.
When is it time to not play by the rules? Some people would say there's never a good time to go off the rails and that a life well lived is its own reward. How about when the rules are hurting people? How about when taking dubious action might actually save lives? I say Afrezza will not hurt anyone who tries it because it's got an unapproved title of Uber fast or Ultra fast in the ad. When is it time to throw the rules out the window? When the competition owns the event, the track, the judges and even the starter pistol. (see the headlines for fraud and abuse by both BP and the FDA over the last decade) The other guys just don't play by the rules.... period. They hide behind lawyers and get slapped on the hand from time to time, but continue doing what they want to do without any serious repercussions. Search your heart and you'll know this to be true.
Why do we follow the rules of the FDA? Fear of the consequences. What did Kim Kardashian get for unauthorized promoting of a morning sickness pill? She got a warning letter. That's it. A letter. OOhh, scaaary. The FDA calls it an admonishment letter. Like that title gives it teeth. It's now time for Mannkind to do an end-around the FDA and put on the full-court press. Print whatever needs to be printed, say what needs to be said and advertise however is needed to salvage this therapy before it's too late. We may have to take a few hits in the news (free advertising) and fight the good fight in court. However, we might just be able, with the help of good attorneys, to shed some light on the criminal bias and general ineptitude of the FDA and help the situation for those to come behind us.
From the FDA site Q & A : Does the FDA approve all ads for drugs before release? Answer: "No. In most cases, federal law does not allow FDA to require drug companies to submit ads for approval before the ads are used. We see many ads about the same time as the public sees them. Many seek advice before they release TV ads. However, If we believe that an ad violates the law, we send a letter to the company ASKING that the ads be stopped right away." I say that is license to do whatever it takes for a while and deal with the consequences as they may come along. Run an ad until we get the letter, then change a few things and hit it again. And again, and again. Court actions can take years to settle and with verbiage in advertising being the biggest cause, I can't see them doing an injunction, pulling approval or anything else too scary to the company. Is it really going to take 12 to 18 more months to get approval for kids? Really? Incredible. Moving at the speed of continents. That is our government's regulatory process.
So, I ask you all, when is enough......enough. How many gray areas can be exploited that haven't been tried? Product placement? Ads that say LESS DEATH or an expose' entitled: DON'T LET THEM TAKE YOUR FEET to get people's attention? I'm done with my rant now. I just took some more x-rays on a patient with diabetic foot ulcers today and it just got me rolling. He's already lost 3 of his toes and the rest of the foot has infection. I asked and he's never even heard of Afrezza. It's so maddening. Now, I've never been one to advocate stepping outside the rules before. However, this long uphill battle just doesn't seem fair to Mannkind or to mankind, if you know what I mean.
Any thoughts? Thanks for listening. Radgray
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Post by saxcmann on Oct 26, 2016 20:50:13 GMT -5
Love it! Corruption and manipulation in WS, FDA, BP, govt and nothing is ever done besides slap on wrist. Get the "truth" out about afrezza now and ask for forgiveness later. I'm down...👍
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Post by dreamboatcruise on Oct 26, 2016 20:51:09 GMT -5
It is widely held belief (or at least I believe it is widely held) that Al Mann's previous criticisms of FDA were one of the factors that contributed to the CRLs that were the beginning of destruction of shareholder value, and even perhaps contributing to study design and label. I think openly flaunting FDA would make future trials and label changes much more risky. It's probably the unofficial punishment that would be the risk more than what would be official. Kim Kardashian isn't counting on getting her pills through FDA approval. If she were, starting off with unauthorized promotion would likely have been a big misstep.
All that said, I think MNKD might be leaning over ski tips a bit on what they are doing in marketing.
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Post by bwills on Oct 26, 2016 21:20:33 GMT -5
I don't know but what if I were locked in a cage with an 800 lb gorilla that I would do too much of anything that might upset him.
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Post by sportsrancho on Oct 26, 2016 21:39:00 GMT -5
Love it! Corruption and manipulation in WS, FDA, BP, govt and nothing is ever done besides slap on wrist. Get the "truth" out about afrezza now and ask for forgiveness later. I'm down...👍 I hear you! I heard about it today. Oh we can't do that... the FDA! Yesterday, oh no, that would be against the FDA! I'm sick to death of the FDA. (( DONT LET THEM TAKE YOUR FEET!!)) |
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Post by madog365 on Oct 26, 2016 21:54:55 GMT -5
Mannkind as a company is beyond conservative, more so then many of the big pharmas Out there. I believe that's partly the reason they brought in Mike to spearhead the commercial organization. It's hard to change a company like this from the inside but you can tell that little by little things are changing slowly. I will admit communications and PR are still god awful.
I know it's frustrating but breaking FDA rules is not the way to go. There's a future that involves going for multiple more FDA approvals and getting on their bad side is a death wish.
Give it time. Yes i know what the next reply will be , we don't have time , we are running out of money , everything will be over in two weeks , blah.
Admit it or not actual Marketing tactics kicked off at the beginning of October. We are 3 weeks in and the proboards ring is filled with towels.
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Post by sportsrancho on Oct 26, 2016 22:07:07 GMT -5
I know madog, I'm venting. Or as mnholdem would say, ...Sports is about ready to blow a gasket! Lol
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Post by op2778 on Oct 26, 2016 22:59:50 GMT -5
Hello Radgray, welcome to The board. I'll give you My honest opinion. I'm From Venezuela. You can see reports about our political situation. Honest people literally dies because they don't have drugs, food, money etc....Honest people fighting against armed police (we fight with word and police with guns). that said I'm amazed how american (i lived 8months in Miami and will Love to live there forever) forget how important is freedom. why I'm writing that? For The following reason: 1. Mrs Hamburg, previous FDA president, marriedd to a guy with an important hedge fund with a big position in Novo Nordisk (If i remember Well). Actually she is under investigation (you can find news about that). 2. Shrekil (he Was caught in flagranti) almost 1yr ago. Still he is living his life and not in jail. This guy sent a letter to Mrs Hamburg on Dec 25 to ask to delay Afrezza approval. Why? Because he had a short position against MNKD. What Mrs Hamburg said: yes and delayed Afrezza approval of about 1yr. To conclude: in few days, you are going to elect a new President. Well, both of them are pathetic. Just think about both candidates and you will find The answer. The honest guys (like you and millions of american and like me get fuc....ked). CO like MNKD (do America great again bla bla bla) get destroyed. Epipen scandal solved with a fine.....Wells Fargo scandal solved with CEO stepping down. Enron crack, Leman Brothers.......do you want me to keep going? Those people (including both presidential candidates are corrupt) and honest guys will get fuc.....ked over and over. big pharma isn't interested to cure people, they want people to be sick to do money. That's The truth. good luck to us, small investors and to MNKD, but, i don't see a Good future. Btw, out own CEO is pathetic, so, don't expect nothing Good From that "honest" guy. OP This will be my first thread over here since giving up on Yahoo several months ago. I'm a little rusty, but here it goes:
On Gray Areas
I've played by the rules my entire life. Honesty is the best policy, follow the golden rule, work hard, play fair, don't cheat, look both ways before crossing...you get the gist. I used to think staying above board was what separated me from the "bad guys." I believe that the straight-forward, honest approach has been taken by Mannkind management in getting Afrezza to patients. Now, I'm afraid that same nice, noble approach may be part of the reason Mannkind is finishing like nice guys unfortunately tend to finish, dead last. The global drug market is a pool of sharks is it not? And the Wall Street crowd seems to have no patience for nice. So, I say, before Afrezza disappears forever into the annuls of history, lets get a little dirty.
When is it time to not play by the rules? Some people would say there's never a good time to go off the rails and that a life well lived is its own reward. How about when the rules are hurting people? How about when taking dubious action might actually save lives? I say Afrezza will not hurt anyone who tries it because it's got an unapproved title of Uber fast or Ultra fast in the ad. When is it time to throw the rules out the window? When the competition owns the event, the track, the judges and even the starter pistol. (see the headlines for fraud and abuse by both BP and the FDA over the last decade) The other guys just don't play by the rules.... period. They hide behind lawyers and get slapped on the hand from time to time, but continue doing what they want to do without any serious repercussions. Search your heart and you'll know this to be true.
Why do we follow the rules of the FDA? Fear of the consequences. What did Kim Kardashian get for unauthorized promoting of a morning sickness pill? She got a warning letter. That's it. A letter. OOhh, scaaary. The FDA calls it an admonishment letter. Like that title gives it teeth. It's now time for Mannkind to do an end-around the FDA and put on the full-court press. Print whatever needs to be printed, say what needs to be said and advertise however is needed to salvage this therapy before it's too late. We may have to take a few hits in the news (free advertising) and fight the good fight in court. However, we might just be able, with the help of good attorneys, to shed some light on the criminal bias and general ineptitude of the FDA and help the situation for those to come behind us.
From the FDA site Q & A : Does the FDA approve all ads for drugs before release? Answer: "No. In most cases, federal law does not allow FDA to require drug companies to submit ads for approval before the ads are used. We see many ads about the same time as the public sees them. Many seek advice before they release TV ads. However, If we believe that an ad violates the law, we send a letter to the company ASKING that the ads be stopped right away." I say that is license to do whatever it takes for a while and deal with the consequences as they may come along. Run an ad until we get the letter, then change a few things and hit it again. And again, and again. Court actions can take years to settle and with verbiage in advertising being the biggest cause, I can't see them doing an injunction, pulling approval or anything else too scary to the company. Is it really going to take 12 to 18 more months to get approval for kids? Really? Incredible. Moving at the speed of continents. That is our government's regulatory process.
So, I ask you all, when is enough......enough. How many gray areas can be exploited that haven't been tried? Product placement? Ads that say LESS DEATH or an expose' entitled: DON'T LET THEM TAKE YOUR FEET to get people's attention? I'm done with my rant now. I just took some more x-rays on a patient with diabetic foot ulcers today and it just got me rolling. He's already lost 3 of his toes and the rest of the foot has infection. I asked and he's never even heard of Afrezza. It's so maddening. Now, I've never been one to advocate stepping outside the rules before. However, this long uphill battle just doesn't seem fair to Mannkind or to mankind, if you know what I mean.
Any thoughts? Thanks for listening. Radgray
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Post by Deleted on Oct 26, 2016 23:11:16 GMT -5
"How many gray areas can be exploited that haven't been tried?"..
From my perspective, freeway banners 40 ft long x 4 feet wide - "Eat anything with inhaled insulin, Afrezza" - would be a start.
...we need to elect, fund raise, vote and execute.
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Post by radgray68 on Oct 27, 2016 11:45:12 GMT -5
O.K. I came up with a few. I like the freeway sign idea, ezy.
1. parking lot leaflets
2. carnival like barkers out on street corners and in front of diabetes clinics. Pay a few minimum wage guys with the signs.
3. skywriting at big events
4. Here's a good one, park benches.
5. My favorite, take about 20 million shares and offer a million to Hollywood stars to promote the drug any way they see fit. If they get a million hits on twitter or something, they get another million shares.
Just spitballing here
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Post by figglebird on Oct 27, 2016 11:55:09 GMT -5
web - what you are thinking is viable but it would take some organizational management, limited funding, and at least one diabetic - resources that would likely need come from share holders whose investment in the company is distinct.
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Post by mockingjay on Oct 27, 2016 12:11:33 GMT -5
This will be my first thread over here since giving up on Yahoo several months ago. I'm a little rusty, but here it goes:
On Gray Areas
I've played by the rules my entire life. Honesty is the best policy, follow the golden rule, work hard, play fair, don't cheat, look both ways before crossing...you get the gist. I used to think staying above board was what separated me from the "bad guys." I believe that the straight-forward, honest approach has been taken by Mannkind management in getting Afrezza to patients. Now, I'm afraid that same nice, noble approach may be part of the reason Mannkind is finishing like nice guys unfortunately tend to finish, dead last. The global drug market is a pool of sharks is it not? And the Wall Street crowd seems to have no patience for nice. So, I say, before Afrezza disappears forever into the annuls of history, lets get a little dirty.
When is it time to not play by the rules? Some people would say there's never a good time to go off the rails and that a life well lived is its own reward. How about when the rules are hurting people? How about when taking dubious action might actually save lives? I say Afrezza will not hurt anyone who tries it because it's got an unapproved title of Uber fast or Ultra fast in the ad. When is it time to throw the rules out the window? When the competition owns the event, the track, the judges and even the starter pistol. (see the headlines for fraud and abuse by both BP and the FDA over the last decade) The other guys just don't play by the rules.... period. They hide behind lawyers and get slapped on the hand from time to time, but continue doing what they want to do without any serious repercussions. Search your heart and you'll know this to be true.
Why do we follow the rules of the FDA? Fear of the consequences. What did Kim Kardashian get for unauthorized promoting of a morning sickness pill? She got a warning letter. That's it. A letter. OOhh, scaaary. The FDA calls it an admonishment letter. Like that title gives it teeth. It's now time for Mannkind to do an end-around the FDA and put on the full-court press. Print whatever needs to be printed, say what needs to be said and advertise however is needed to salvage this therapy before it's too late. We may have to take a few hits in the news (free advertising) and fight the good fight in court. However, we might just be able, with the help of good attorneys, to shed some light on the criminal bias and general ineptitude of the FDA and help the situation for those to come behind us.
From the FDA site Q & A : Does the FDA approve all ads for drugs before release? Answer: "No. In most cases, federal law does not allow FDA to require drug companies to submit ads for approval before the ads are used. We see many ads about the same time as the public sees them. Many seek advice before they release TV ads. However, If we believe that an ad violates the law, we send a letter to the company ASKING that the ads be stopped right away." I say that is license to do whatever it takes for a while and deal with the consequences as they may come along. Run an ad until we get the letter, then change a few things and hit it again. And again, and again. Court actions can take years to settle and with verbiage in advertising being the biggest cause, I can't see them doing an injunction, pulling approval or anything else too scary to the company. Is it really going to take 12 to 18 more months to get approval for kids? Really? Incredible. Moving at the speed of continents. That is our government's regulatory process.
So, I ask you all, when is enough......enough. How many gray areas can be exploited that haven't been tried? Product placement? Ads that say LESS DEATH or an expose' entitled: DON'T LET THEM TAKE YOUR FEET to get people's attention? I'm done with my rant now. I just took some more x-rays on a patient with diabetic foot ulcers today and it just got me rolling. He's already lost 3 of his toes and the rest of the foot has infection. I asked and he's never even heard of Afrezza. It's so maddening. Now, I've never been one to advocate stepping outside the rules before. However, this long uphill battle just doesn't seem fair to Mannkind or to mankind, if you know what I mean.
Any thoughts? Thanks for listening. Radgray
Sorry I don't want to break any rule, if it's the case , a lot of bad drugs will flood the market and you know the consequence . |
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Post by radgray68 on Oct 27, 2016 12:42:08 GMT -5
"Sorry I don't want to break any rule, if it's the case , a lot of bad drugs will flood the market and you know the consequence ."
I'm not following you. What do our marketing efforts have to do with any other drugs? I'm not talking blatant false advertising here. I'm talking about advertising the facts that we are willing to defend in court.(also free advertising) Ask forgiveness from the FDA later rather than permission now.
I see Tylenol advertised EVERYWHERE. doesn't it have a black box warning. I never see too much effort put into the warnings on those advertisements. Besides, we are talking about human insulin here. It's floating around in our blood 24/7/365 anyway. Nobody gets harmed by our drug being advertised and nobody says " hey, they sold an insulin without a warning, now I can sell my crack."
Again, when is it time to paint in the gray areas? When nobody will get hurt. Heck, in this day and age, think Hillary. When the FDA asks for our records, oops, they got erased. Or, think Trump, and reply "it didn't happen" We seem to be the only ones suffering from following the blinking rules.
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Post by derek2 on Oct 27, 2016 12:59:33 GMT -5
Poe's law applies to the content below:
Here are a few ideas, although I know they're kind of crazy:
1. Pay expenses for users active on social media, who use terms like "ultra fast", "no hypo" and make up non-permitted reminder ads, to attend sales training, treatment protocol strategy sessions, and events where MNKD has a booth. But, you know, they aren't affiliated in any way so they can speak freely and with great creativity.
2. Turn a blind eye when copycat websites copy your content, cobrand your videos, and neglect to post that pesky prescribing info summary on their home page. Because, you know, even though they screen scrape your website they are totally unaffiliated.
That is to say, all joking aside, MNKD is actually pushing a few limits in order to gain some exposure. Harmless, I think.
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Post by zuegirdor on Oct 27, 2016 13:06:39 GMT -5
"Sorry I don't want to break any rule, if it's the case , a lot of bad drugs will flood the market and you know the consequence ." I'm not following you. What do our marketing efforts have to do with any other drugs? I'm not talking blatant false advertising here. I'm talking about advertising the facts that we are willing to defend in court.(also free advertising) Ask forgiveness from the FDA later rather than permission now. I see Tylenol advertised EVERYWHERE. doesn't it have a black box warning. I never see too much effort put into the warnings on those advertisements. Besides, we are talking about human insulin here. It's floating around in our blood 24/7/365 anyway. Nobody gets harmed by our drug being advertised and nobody says " hey, they sold an insulin without a warning, now I can sell my crack." Again, when is it time to paint in the gray areas? When nobody will get hurt. Heck, in this day and age, think Hillary. When the FDA asks for our records, oops, they got erased. Or, think Trump, and reply "it didn't happen" We seem to be the only ones suffering from following the blinking rules. For my part, it amazes me also that someone who has treated their diabetes for 5 or even 2 or 3 years outside the clinic, AS MOST DIABETES IN ADULTS AND TEENS IS TREATED, still has to have a prescription for insulin. Admittedly this is more about the cost coverage and HMO intermediaries. But this arrangement also builds a perception about diabetes, insulin and Drs involvement that is inaccurate, and as we are finding with Afrezza - HARMFUL. As you become experienced with this condition you better understand the importance, no the IMPERATIVE of Individual Treatment, Choice and access to medications by the PATIENT. We need to go further by stressing the importance of Psychological benefits new treatments like Afrezza, that increases Blood glucose control, reduced danger from hypos and greater lifestyle freedom, may afford. We don't really need to break rules so much as push the limit of narrowly interpreted rules that under serve patient interests. I agree some rules are a problem. It is also true that bad laws make the good laws weaker. There is nothing illegal about pushing against these weaknesses, just as there is nothing illegal about a Dr writing an off-label prescription-they do it all the time! But we have to be careful too. There have been recent changes at regulatory level that have yet to trickle down to Drs. We may blame the HMOs and pharma for some of this. But we cannot alienate them. We need them to acknowledge the real world diabetic and Afrezza user experiences. |
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