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Post by end2war on Apr 12, 2016 14:09:27 GMT -5
I have never heard of any advocacy group of users forming behind a drug before. This is a very exceptional thing and the ramifications are what got me interested in MNKD.
There are a lot of different reasons to buy and hold MNKD. I think Michael Castagna says it best:
"The reason I took the job is that I've been in this industry 20 years and I've had lots of specialty brands, but I've never had a brand that had patient advocates like this one who aren't paid and have no real ties to the company, but they just love this product and are authentic advocates on how it's radically shifted their life in a positive way," he said.
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Post by slugworth008 on Apr 12, 2016 14:35:56 GMT -5
I have never heard of any advocacy group of users forming behind a drug before. This is a very exceptional thing and the ramifications are what got me interested in MNKD. There are a lot of different reasons to buy and hold MNKD. I think Michael Castagna says it best: "The reason I took the job is that I've been in this industry 20 years and I've had lots of specialty brands, but I've never had a brand that had patient advocates like this one who aren't paid and have no real ties to the company, but they just love this product and are authentic advocates on how it's radically shifted their life in a positive way," he said. I believe Mr. Castagna knows exactly how to market Afrezza. I would love to see him onboard some of the early adopters into a campaign. Good times ahead for MNKD - JMHO |
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Post by end2war on Apr 12, 2016 14:43:04 GMT -5
I have long believed that an advertising campaign based upon endorsements of actual users will have the greatest effect, especially if it tells their stories.It seems pretty clear that Michael Castagna will make good use, not only of the dedicated users who will speak out in favor of Afrezza, but also, hopefully, they will tell others how they used Afrezza to get great A1c scores. Once it is better understood how to use Afrezza, there will be less users that drop off. Also, I'm sure they are going to target the group of users that employ technology to monitor their blood sugar. Now that they know what works, getting that message to the doctors is an essential part of the next stage of the launch.
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Post by nylefty on Apr 12, 2016 15:08:02 GMT -5
The tricky part is keeping within the boundaries set by the FDA. Users can say whatever they want if they're not being paid by MannKind or appearing in MannKind's advertising. But Mannkind can't use them to get around the FDA restrictions on what it can say about Afrezza.
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Post by lakon on Apr 12, 2016 15:29:31 GMT -5
So if a third party, such as a non-profit, financed early adopters to tell their story, that would be perfectly legal...
As the number of verified results increases, the anecdotal becomes empirical...
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Post by nylefty on Apr 12, 2016 16:02:49 GMT -5
So if a third party, such as a non-profit, financed early adopters to tell their story, that would be perfectly legal. Sort of like the Super PACs in the political world, that supposedly have no connection to the candidates they're backing. But would it be illegal to donate to one if you were a MannKind shareholder? |
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Post by dreamboatcruise on Apr 12, 2016 16:25:26 GMT -5
So if a third party, such as a non-profit, financed early adopters to tell their story, that would be perfectly legal. Sort of like the Super PACs in the political world, that supposedly have no connection to the candidates they're backing. But would it be illegal to donate to one if you were a MannKind shareholder? I'm not so clear about that. I think marketing drugs is under the control of FDA regardless. The grey area comes, perhaps where VDEX can play, in that FDA does not regulate marketing of the practice of medicine. So as long as VDEX is marketing their overall system of care then they can use patient results. I could be wrong but I don't think anyone could go on TV with a commercial saying Afrezza lowered my A1c from 7 to 5.7... with supplement like fine print at the bottom saying "results may vary". |
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Post by rockstarrick on Apr 12, 2016 17:11:02 GMT -5
Sort of like the Super PACs in the political world, that supposedly have no connection to the candidates they're backing. But would it be illegal to donate to one if you were a MannKind shareholder? I'm not so clear about that. I think marketing drugs is under the control of FDA regardless. The grey area comes, perhaps where VDEX can play, in that FDA does not regulate marketing of the practice of medicine. So as long as VDEX is marketing their overall system of care then they can use patient results. I could be wrong but I don't think anyone could go on TV with a commercial saying Afrezza lowered my A1c from 7 to 5.7... with supplement like fine print at the bottom saying "results may vary". You are correct, other than an afrezzauser sharing their own personal experience, nobody will be able to "Advertise" the real benefits of Afrezza until the official label change. With that said, label changes seem to be fairly common. I get updates from the Office of Prescription Drug Promotions, (OPDP) and see label updates frequently. www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090142.htmOne step at a time !! With a real marketing plan, and somebody actually trying to sell Afrezza, does anybody really think it won't sell ?? Not me. |
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Post by sweedee79 on Apr 12, 2016 19:29:12 GMT -5
The tricky part is keeping within the boundaries set by the FDA. Users can say whatever they want if they're not being paid by MannKind or appearing in MannKind's advertising. But Mannkind can't use them to get around the FDA restrictions on what it can say about Afrezza. agreed... .. but I think Castagna gets it.. so hopefully they can find a creative way around it.. it seems they believe they can..
here is what Castagna said in the Fierce Pharma article:
"MannKind will maintain a consumer website in the meantime, he said, and may do some targeted direct-to-patient communications in larger markets that already have a core group of doctors and patients who understand the product"
www.fiercepharmamarketing.com/story/back-control-afrezza-mannkind-refocuses-endocrinologists-give-launch-jolt/2016-04-11
I feel very positive about Castagna and all that is going on right now... just a gut feeling.. but I think we all need to realize that this is going to take a bit longer than if our label was already changed.... so much easier to educate if you can actually say what you need to say...
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Post by agedhippie on Apr 12, 2016 19:45:16 GMT -5
"MannKind will maintain a consumer website in the meantime, he said, and may do some targeted direct-to-patient communications in larger markets that already have a core group of doctors and patients who understand the product" Wasn't this suggested a while back? Pick an area with a lot of Afrezza prescribers and to local DTC TV adverts. |
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Post by sweedee79 on Apr 12, 2016 20:03:15 GMT -5
"MannKind will maintain a consumer website in the meantime, he said, and may do some targeted direct-to-patient communications in larger markets that already have a core group of doctors and patients who understand the product" Wasn't this suggested a while back? Pick an area with a lot of Afrezza prescribers and to local DTC TV adverts. It probably was suggested... not sure... I guess I missed that... but it sounds like a good idea.. If we can get one area going strong that will be testimony for docs in other areas.. credible and faster word of mouth.. |
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Post by sweedee79 on Apr 12, 2016 20:17:17 GMT -5
I'm not so clear about that. I think marketing drugs is under the control of FDA regardless. The grey area comes, perhaps where VDEX can play, in that FDA does not regulate marketing of the practice of medicine. So as long as VDEX is marketing their overall system of care then they can use patient results. I could be wrong but I don't think anyone could go on TV with a commercial saying Afrezza lowered my A1c from 7 to 5.7... with supplement like fine print at the bottom saying "results may vary". You are correct, other than an afrezzauser sharing their own personal experience, nobody will be able to "Advertise" the real benefits of Afrezza until the official label change. With that said, label changes seem to be fairly common. I get updates from the Office of Prescription Drug Promotions, (OPDP) and see label updates frequently. www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090142.htmOne step at a time !! With a real marketing plan, and somebody actually trying to sell Afrezza, does anybody really think it won't sell ?? Not me. I think it would be a catastrophe to advertise that my blood sugar dropped from 7 to 5.7 etc... without the docs being educated first... docs have to know how to prescribe it for people to get these A1Cs.... its not the same as injectable... Wouldn't that hurt our credibility...  If people go to their docs and then don't have these good results they may think we are false advertising... I don't know.. I guess that had I not known what Afrezza really was when dad and I went.. we may have given up on it.. One thing we found out too is that it takes a while for your body to adjust to Afrezza after being on injectable.. In the first weeks and probably a month dads blood sugars weren't that great on Afrezza .. I asked Afrezzauser about it and he said to give the body time to adjust.. there is so much to know about this insulin in order to get good results.. we also had to bump the dose up.. its just not the same thing as injectable.. these are the things that concern me.. But I think MNKD understands this too.. |
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Post by rockstarrick on Apr 12, 2016 20:36:35 GMT -5
You are correct, other than an afrezzauser sharing their own personal experience, nobody will be able to "Advertise" the real benefits of Afrezza until the official label change. With that said, label changes seem to be fairly common. I get updates from the Office of Prescription Drug Promotions, (OPDP) and see label updates frequently. www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090142.htmOne step at a time !! With a real marketing plan, and somebody actually trying to sell Afrezza, does anybody really think it won't sell ?? Not me. I think it would be a catastrophe to advertise that my blood sugar dropped from 7 to 5.7 etc... without the docs being educated first... docs have to know how to prescribe it for people to get these A1Cs.... its not the same as injectable... Wouldn't that hurt our credibility... If people go to their docs and then don't have these good results they may think we are false advertising... I don't know.. I guess that had I not known what Afrezza really was when dad and I went.. we may have given up on it.. One thing we found out too is that it takes a while for your body to adjust to Afrezza after being on injectable.. In the first weeks and probably a month dads blood sugars weren't that great on Afrezza .. I asked Afrezzauser about it and he said to give the body time to adjust.. there is so much to know about this insulin in order to get good results.. we also had to bump the dose up.. its just not the same thing as injectable.. these are the things that concern me.. But I think MNKD understands this too.. The neat thing is, once you do get it dialed in, the battle seems to be over. I believe it was blindhog that posted on YMB that low and stable BS is now normal for him. With the injectable insulin options it seems like a lot more work and worry for results that are not nearly as good as Afrezza. And knowing how convenient Afrezza is to use, and how great it works, (for most) is half the battle. I believe once enough Physicians and PWD consistently see the numbers Afrezza is knocking out, they will become advocates for a proper label !! A drug label shouldn't be drafted to scare away possible patients, especially one that appears as safe and efficient as Afrezza. If you believe the drug is that risky, why approve it ?? Our label will get right IMO. |
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Post by slugworth008 on Apr 12, 2016 20:41:04 GMT -5
I have long believed that an advertising campaign based upon endorsements of actual users will have the greatest effect, especially if it tells their stories.It seems pretty clear that Michael Castagna will make good use, not only of the dedicated users who will speak out in favor of Afrezza, but also, hopefully, they will tell others how they used Afrezza to get great A1c scores. Once it is better understood how to use Afrezza, there will be less users that drop off. Also, I'm sure they are going to target the group of users that employ technology to monitor their blood sugar. Now that they know what works, getting that message to the doctors is an essential part of the next stage of the launch. Good post end2war. Having actual users tell their story will send a powerful message IMO as well. I believe the drop off rate will virtually cease as soon as Afrezza gets better insurance formulary status - via better pricing and or other means. |
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Post by lakon on Apr 13, 2016 12:36:38 GMT -5
Sort of like the Super PACs in the political world, that supposedly have no connection to the candidates they're backing. But would it be illegal to donate to one if you were a MannKind shareholder? I'm not so clear about that. I think marketing drugs is under the control of FDA regardless. The grey area comes, perhaps where VDEX can play, in that FDA does not regulate marketing of the practice of medicine. So as long as VDEX is marketing their overall system of care then they can use patient results. I could be wrong but I don't think anyone could go on TV with a commercial saying Afrezza lowered my A1c from 7 to 5.7... with supplement like fine print at the bottom saying "results may vary". Yes, the legal argument is how does one define "marketing". Also, I would change the word "control" to either "authority" or "administration". From what you say about the practice of medicine, it follows: If the FDA were to try to curb the First Amendment rights of a non-affiliated private citizen, or entity, who was only stating facts or opinions, be they anecdotal or otherwise, well, the Supreme Court would have another case to hear... The federal government does not grant medical licenses. The FDA does not have authority over the practice of medicine. State medical boards handle licensing the practice of medicine, and the Constitution handles WE THE PEOPLE. Until the Supreme Court rules, the FDA gets away with running roughshod over Pharma. This is good when Pharma is misbehaving. This is bad when FDA is misbehaving. Facts are facts whether or not people realize them as such. Now, if the entity were foreign and in a foreign jurisdiction, the FDA would have a lot of trouble on their hands. Domestically, they can bluff until someone is willing to call them on it. That's the case that they lost in federal court. Bet they don't push their luck on it, or the house of cards could come crashing down. There will be a concerted effort by the FDA to get ahead of this; hence, the efforts to "allow" certain types of anecdotal evidence... This is politics folks so I digress. My point was simply that there are many ways for the word to get out about Afrezza. The truth cannot be suppressed forever. MNKD will take a methodical, likely conservative, and definitely legal approach. Patients and doctors may be far more aggressive as they begin to BELIEVE... Therefore, BUY and HOLD until the fireworks begin. |
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If people go to their docs and then don't have these good results they may think we are false advertising... I don't know.. I guess that had I not known what Afrezza really was when dad and I went.. we may have given up on it.. One thing we found out too is that it takes a while for your body to adjust to Afrezza after being on injectable.. In the first weeks and probably a month dads blood sugars weren't that great on Afrezza .. I asked Afrezzauser about it and he said to give the body time to adjust.. there is so much to know about this insulin in order to get good results.. we also had to bump the dose up.. its just not the same thing as injectable.. these are the things that concern me.. But I think MNKD understands this too..