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Post by mockingjay on Oct 27, 2016 13:14:23 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. Sorry, it's not about the court, FDA can remove the drug anytime out of market if you don't follow the label or their recommendation, they don't need going to the court for this . |
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Post by peppy on Oct 27, 2016 14:15:23 GMT -5
At this point, I am going to type something very inappropriate. Consider afrezza is disruptive. Disruptive to the status quo.
I have been watching afrezza/MNKD price go down since the 2015 ada. We have proof through continuous glucose monitors of good post meal glucose control and the first users that they like afrezza and that type ones can eat.
So the status quo does not welcome this disruption. It is being squashed.
Inappropriately, it is a lot like free energy that can be seen on youtube. everytime someone gets zero point energy up and running, it shut down. Lives threatened and devices taken away.
Dr. Steven Greer OCTOBER 18, 2016 (NEW) www.youtube.com/watch?v=dOdhJgCuEog
I see the idiot I am. Thinking a really good mealtime insulin that works as well as afrezza should be successful. It is a big world.
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Post by radgray68 on Oct 27, 2016 14:32:30 GMT -5
You understand, though, going to court allows us to call in Margaret Hamburg, Martin Skrelli, former Sanofi employees etc. to the stand to testify about the handling of Afrezza by the FDA and others. Make the court an arena for bringing ALL the FDA's dirty laundry to bear. Everything they have done wrong for the past decade would be up for grabs. We could parade everybody with a beef in front of the judge to make our point. Any coverage we get from the media, general or social would be advertising. At least the public would have the name out there to discuss. Handle this business out of boldness, not fear. America loves the underdog. (i.e. go Cubs) Mannkind IS the underdog here.
By fighting it out with the FDA, they would be forced to at least be above-board in dealing with us from that time on as they would know we are ready to fight for what is right. Monomeric human insulin, just like your pancreas produces, is not going to harm people like these oral meds they are peddling today all over the place. Every time I turn on the TV it's another diabetes commercial. You have to have noticed that. We can't steamroll Big Pharma but we sure as heck can be a painful thorn in their side. BP crushes us in court and we made our point.
I'd sue Sanofi at the same time. Genzyme and others could be called as well. This is NOT the first time Sanofi has sandbagged a product. Win or lose, we get attention for our drug and argue our case one more time before we are forced to close the doors forever. JMHO
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Post by zuegirdor on Oct 27, 2016 17:36:38 GMT -5
What I cannot understand is why nobody is following this story purely for its dramatic potential? Mother Jones? Rolling Stone? This story is so emblematic of the times, of what is not working in our finance driven economy. There is a film maker following the development of the Viacyte AP (a real AP!) She is crowd funding that effort. There are teasers on you tube. I cannot recall the name of the film
But if you ask me, she is following the wrong story. She could do the Afrezza story just by picking up leads on this site, twitter and tudiabetes. Use her "fame and fortune" doing the investigative piece on Afrezza so she can then get the money to fund the piece on the technology that will put Afrezza out of business. Seems like a natural winner to me.
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Post by mango on Oct 27, 2016 18:31:34 GMT -5
At this point, I am going to type something very inappropriate. Consider afrezza is disruptive. Disruptive to the status quo.
I have been watching afrezza/MNKD price go down since the 2015 ada. We have proof through continuous glucose monitors of good post meal glucose control and the first users that they like afrezza and that type ones can eat.
So the status quo does not welcome this disruption. It is being squashed.
Inappropriately, it is a lot like free energy that can be seen on youtube. everytime someone gets zero point energy up and running, it shut down. Lives threatened and devices taken away.
Dr. Steven Greer OCTOBER 18, 2016 (NEW) www.youtube.com/watch?v=dOdhJgCuEog
I see the idiot I am. Thinking a really good mealtime insulin that works as well as afrezza should be successful. It is a big world.
Snake oil salesman. Known fraud. I haven't forgotten about the cactus and the moth. |
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Post by nylefty on Oct 27, 2016 18:39:35 GMT -5
What I cannot understand is why nobody is following this story purely for its dramatic potential? Mother Jones? Rolling Stone? This story is so emblematic of the times, of what is not working in our finance driven economy. There is a film maker following the development of the Viacyte AP (a real AP!) She is crowd funding that effort. There are teasers on you tube. I cannot recall the name of the film The film is "The Human Trial." From the film's website: The Human Trial is a feature-length documentary with unprecedented, real-time access to one of America’s top labs — ViaCyte in San Diego. This groundbreaking film follows the team’s triumphs and failures in the lab as they attempt to make medical history at a landmark clinical trial in 2015.
More than 90 years after the discovery of insulin, ViaCyte has received FDA approval to launch the first ever-human trial of a stem-cell derived treatment that might cure type 1 diabetes. ViaCyte’s trial is only the third ever in the US, and the sixth ever in the world to use embryonic stem cell therapy to cure a disease. Only a decade ago America was torn apart by a political and religious debate about the ethics of using human embryos for stem cell research.
Now, The Human Trial will film the first six months of the first phase of the trial, to document every step of this remarkable moment in medical science. thehumantrial.com |
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Post by LosingMyBullishness on Oct 27, 2016 18:44:34 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. Well, to stay in the picture. The gorilla and his boys already f##ked the hell out of you. Get them angry, avoid the punches and one of them might break the cage. Little to lose. |
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Post by mnkdfann on Oct 27, 2016 19:12:59 GMT -5
What I cannot understand is why nobody is following this story purely for its dramatic potential? Mother Jones? Rolling Stone? This story is so emblematic of the times, of what is not working in our finance driven economy. Someone was, but perhaps the drama put him to sleep? mnkd.proboards.com/thread/5805/afrezza-documentary-coming |
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Post by mango on Oct 27, 2016 20:19:39 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
What's her name? CEO of that EpiPen company? "donated" a lot of $ to the Clinton Foundation? Her father is a Dem. Her mother, father, and herself, are all involved in felonies... that will never manifest. Ask yourself, do you really want MannKind to go to this level? I don't. It is easy to swim with the sharks. But when you fed 'em you never know when they will eat you for all you have. It is a commitment. We don't want to be a commitment to the sharks. Dolphins are pretty damn smart? If you want to get mad, get mad about the monolopy of mass murder that Big Tobacco, the FDA, and POTUS have created. I get your frustration, but Al Mann would not, and did not, go to this level for a reason. MannKind is not over yet. |
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Post by nylefty on Oct 27, 2016 20:36:26 GMT -5
What I cannot understand is why nobody is following this story purely for its dramatic potential? Mother Jones? Rolling Stone? This story is so emblematic of the times, of what is not working in our finance driven economy. Someone was, but perhaps the drama put him to sleep? mnkd.proboards.com/thread/5805/afrezza-documentary-comingHis website no longer works. doingtimeproductions.com |
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Post by mnkdfann on Oct 27, 2016 20:41:30 GMT -5
His website no longer works. doingtimeproductions.com Clearly the staus quo powers took him out. Good night, sweet prince. RIP.  |
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