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Post by agusta on Feb 9, 2017 16:23:00 GMT -5
Someone please explain how the product VIPoo is able to run TV commercials in the Cleveland market, Distribute the product in Walmart, where I have seen it - sure else where ... It's a spray you use in the toilet prior to pooping to prevent smells. WHERE DO THEY HAVE THE MONEY FOR ADVERTISING? UTube: Look up: The new pre-poo toilet spray - You Tube. We have a life changing drug and this product is brought to life? REALLY?  |
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Post by otherottawaguy on Feb 9, 2017 16:26:05 GMT -5
Probably because it does not require a billion dollar tab for FDA testing.
OOG
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Post by peppy on Feb 9, 2017 16:28:45 GMT -5
I was thinking the same, that pot porri commercial on youtube is long. My pillow, and the guy trying to get you into his real estate scam.
I guess the Federal Drug Administration is not involved.
put outinsulin on a rollercoaster and enough already.
heh
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Post by careful2invest on Feb 9, 2017 16:50:36 GMT -5
Probably because it does not require a billion dollar tab for FDA testing. OOG The FDA costs are behind us. And they came up with the cash to fight through 2 CRL'S and a botched partnership with Sanofi. With the ball (AFREZZA) at the one yard line, the hardest and most expensive portion is behind us. Lets get this done. And not at the cost of the retail investor. We have suffered enough! Certainly the MANN Foundation does not and will not go this far only to ultimately fail, or potentially fail! Pony up whatever the cost could be for a effective advertising promotion. Once enough people are successfully using AFREZZA, it will sell itself. But not if no one knows about it! Due to the efforts of Mike C and the MNKD team, The initial bugs have been worked out with insurance issues and proper titration, Just let the world know that AFREZZA exists! And the multiple benefits of implimenting it to battle Diabetes.
AFREZZA's performance is second only to the function of a healthy human pancreas.No other drug can make that claim!
Add to that, Non diabetic A1C's !!Those statements alone can and will spark interest in AFREZZA. But not if you keep it a secret! Two plus years after approval, and still no active sales promotion?? It just does not make sense! Come on MNKD! |
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Post by sweedee79 on Feb 9, 2017 17:54:19 GMT -5
Probably because it does not require a billion dollar tab for FDA testing. OOG The FDA costs are behind us. And they came up with the cash to fight through 2 CRL'S and a botched partnership with Sanofi. With the ball (AFREZZA) at the one yard line, the hardest and most expensive portion is behind us. Lets get this done. And not at the cost of the retail investor. We have suffered enough! Certainly the MANN Foundation does not and will not go this far only to ultimately fail, or potentially fail! Pony up whatever the cost could be for a effective advertising promotion. Once enough people are successfully using AFREZZA, it will sell itself. But not if no one knows about it! Due to the efforts of Mike C and the MNKD team, The initial bugs have been worked out with insurance issues and proper titration, Just let the world know that AFREZZA exists! And the multiple benefits of implimenting it to battle Diabetes.
AFREZZA's performance is second only to the function of a healthy human pancreas.No other drug can make that claim!
Add to that, Non diabetic A1C's !!Those statements alone can and will spark interest in AFREZZA. But not if you keep it a secret! Two plus years after approval, and still no active sales promotion?? It just does not make sense! Come on MNKD! With label restrictions I doubt it would be legal for MNKD to say all of that.... but at least now lets get the word out nationwide .. create a buzz .. get people searching the internet trying to find out about it... perhaps they will stumble onto those who are using it with great success... I'm beginning to think that we no longer have time to wait til every single duck is in a row... what will we do when the money runs out and there isn't any place else to turn for more funding after dilution.... ??
My dad didn't use any complicated titration... he followed the same dosing as injectable... yes his numbers could have been better, but he did have success because he lost weight... he felt better... We may not have the retention rate that we would have if we were able to advertise what we know about Afrezza, yet cant say .. but at least the word will be out... its time..
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Post by agedhippie on Feb 9, 2017 18:49:35 GMT -5
AFREZZA's performance is second only to the function of a healthy human pancreas.No other drug can make that claim!
Add to that, Non diabetic A1C's !!Those statements alone can and will spark interest in AFREZZA. But not if you keep it a secret! Two plus years after approval, and still no active sales promotion?? It just does not make sense! Come on MNKD! Those statements alone will get you into serious trouble with the FDA. I don't understand why people keep thinking we are advertising consumer goods here, these are drugs and advertising is heavily regulated. In foot high letters - You cannot make a claim in an advert that is unsupported by the label. End of story. |
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Post by nylefty on Feb 9, 2017 19:08:03 GMT -5
Probably because it does not require a billion dollar tab for FDA testing. OOG
AFREZZA's performance is second only to the function of a healthy human pancreas.No other drug can make that claim!
Add to that, Non diabetic A1C's !!MannKind can't make those claims either, because of the FDA. Why is that so hard to understand? |
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Post by paaz77 on Feb 9, 2017 20:54:55 GMT -5
My take on this…
For whatever reason, endos won’t prescribe it, at least mine won’t. I witnesses this first hand. Even my PCP, who got me on metformin before I went to the endo to get a script for Afrezza, was against it. I witnesses this first hand. Very arrogant or very conservative. I’m sure most folks like me rush to WebMD to research and diagnose themselves or loves ones, so I patient discussing an illness and how to treat it shouldn’t be a new concept to doctors these days.
I have decent insurance so the cost wasn’t a big problem but the person I need to write the script was. Dam endo is between me and my meds. I can’t write a script for myself.
It appears that other specialty doctors that I had to see for a variety of other ailments were more receptive or open minded to new treatment methods or medicine that I suggest. Kind a like a partnership to ensure the best options for MY health. Not my endo. It’s like Endo means with no when it comes to Afrezza. I’ve learned endo’s or Doctors that treat diabetes are a different breed (status quo) of doctors.
Either mnkd knew this and partnered with one of the biggest pharma companies to use their clout to help breakthrough the barriers of insurance and endos, if not, they know now.
Either way, I believe mnkd is waiting on a response from the FDA on the label improvement before airing any dtc TV commercials for obvious reasons. Brand awareness to PWD, those reluctant endos and also new investors. Once “fastest” and “best in class” are added to the label, with finally getting more insurance coverage, the new titration pack, along with dtc television, it will be more difficult for endos not to write scripts and to sell outside the US. Things will get interesting very fast.
Insurance coverage + new titration pack + label + salesforce + dtc television = endos write scripts
Insurance coverage + new titration pack + label + salesforce + dtc television + endos write scripts = international expansion.
Insurance coverage + new titration pack + label + salesforce + dtc television + endos write scripts + international expansion = about time $
I’m just pissed that I didn’t just find out about this company to start my investment now, as my money has been rotting away for many years. I think mnkd is racing against the cash runway clock to get the label changed to really shift things into the next phase. Everything else is lining up.
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Post by sluggobear on Feb 9, 2017 21:02:16 GMT -5
Ad opens in darkness with audible "click".
Close-up of Jeffrey "The Dude" Lebowski in a bathrobe taking a hit on the Dreamboat. In a restaurant, courtroom, bathtub.
"Hey man,I INHALED!" Waits 3s. Eyes go wide. "Wow that's fast!"
Dark, quiet. "Click". Power chord played as stage lights come up to reveal Nick Jonas or Adam Lasher or Bret Michaels (Neil Young?) hitting the Dreamboat while holding power chord.
"I INHALED!" Eyes go wide. "Wow that's fast!" Plays ripping high speed lick.
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Post by nylefty on Feb 9, 2017 21:18:04 GMT -5
Either way, I believe mnkd is waiting on a response from the FDA on the label improvement before airing any dtc TV commercials for obvious reasons. Brand awareness to PWD, those reluctant endos and also new investors. Once “fastest” and “best in class” are added to the label, with finally getting more insurance coverage, the new titration pack, along with dtc television, it will be more difficult for endos not to write scripts and to sell outside the US. Things will get interesting very fast. Bingo! Looking forward to the day when the real benefits of Afrezza can be advertised, which is NOT the case now. |
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Post by careful2invest on Feb 9, 2017 21:42:44 GMT -5
AFREZZA's performance is second only to the function of a healthy human pancreas.No other drug can make that claim!
Add to that, Non diabetic A1C's !!MannKind can't make those claims either, because of the FDA. Why is that so hard to understand? Ny lefty and agedhippi... There is a pharmacokinetics graph floating around (that I'm sure that you have all seen) that shows in one color how insulin is naturally released in a healthy non diabetic human. In a different color on the same graph, it shows the performance of AFREZZA. That graph alone displays how closely that AFREZZA works nearly duplicating the release of insulin in a healthy person. MNKD has shown that graph in conference calls and in several presentations. What other drug can come closer to duplicating a healthy pancreas than AFREZZA. There is scientific proof behind that study. That graph alone sells the product to anyone with half of a clue. You are telling me that MNKD is allowed to show that in a demonstration to the masses but is not allowed to make that same claim in an advertisement?? That just does not make sense! If MNKD cannot, there has to be some other way to get the word out! In addition, You are stating that MNKD cannot say that "we have had patients that have been using our product that are experiencing non diabetic A1C's after using AFREZZA" in the same manner as you would expose any negative possible side effect?? Like Weight loss, weight gain, rash etc..) Along with the disclaimer that " your results may differ" Something can and has to be done to let the world know about AFREZZA! There has always been an excuse as to why there has not been any promotion of AFREZZA. First, it was a "slow launch" and we all took the bait, (me included) then it was "we are restricted by Sanofi" (which may have been true) Now, it's basically being said by a few on this board ( that may be correct) that "we are restricted by the FDA" As everyone knows, we must adhere to FDA guidelines, but are you absolutely certain about these points? I will be doing my own DD to look into this further and I am asking others to do so. Because to me...It just does not add up! The "silence" ever since the FDA approval has been unnatural for a Revolutionary "life changing" Drug that is AFREZZA! GLTA TRUE LONGS! |
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Post by dreamboatcruise on Feb 9, 2017 23:02:53 GMT -5
MannKind can't make those claims either, because of the FDA. Why is that so hard to understand? Ny lefty and agedhippi... There is a pharmacokinetics graph floating around (that I'm sure that you have all seen) that shows in one color how insulin is naturally released in a healthy non diabetic human. In a different color on the same graph, it shows the performance of AFREZZA. That graph alone displays how closely that AFREZZA works nearly duplicating the release of insulin in a healthy person. MNKD has shown that graph in conference calls and in several presentations. What other drug can come closer to duplicating a healthy pancreas than AFREZZA. There is scientific proof behind that study. That graph alone sells the product to anyone with half of a clue. You are telling me that MNKD is allowed to show that in a demonstration to the masses but is not allowed to make that same claim in an advertisement?? That just does not make sense! If MNKD cannot, there has to be some other way to get the word out! In addition, You are stating that MNKD cannot say that "we have had patients that have been using our product that are experiencing non diabetic A1C's after using AFREZZA" in the same manner as you would expose any negative possible side effect?? Like Weight loss, weight gain, rash etc..) Along with the disclaimer that " your results may differ" Something can and has to be done to let the world know about AFREZZA! There has always been an excuse as to why there has not been any promotion of AFREZZA. First, it was a "slow launch" and we all took the bait, (me included) then it was "we are restricted by Sanofi" (which may have been true) Now, it's basically being said by a few on this board ( that may be correct) that "we are restricted by the FDA" As everyone knows, we must adhere to FDA guidelines, but are you absolutely certain about these points? I will be doing my own DD to look into this further and I am asking others to do so. Because to me...It just does not add up! The "silence" ever since the FDA approval has been unnatural for a Revolutionary "life changing" Drug that is AFREZZA! GLTA TRUE LONGS! FDA is pretty darn restrictive. Go to the Afrezza.com website and look at the page on "outsulin". What is said there is likely right up to the limit of what they feel they can get away with. If they could say any of the other things like you'd wish in an TV advert, why aren't they already doing it on the web page. Absolutely, they CANNOT use anecdotal patient results as is done with nutritional supplements with "your results may differ". Clinical benefits can only be stated if proven to be statistically significant in an FDA approved trial. When it comes to FDA approved drugs, simply watch the TV commercials that run day and night. The lack of the things you are hoping to see for Afrezza isn't because they have bad ad agencies that are less creative than you are... it is because they are constrained by FDA. |
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Post by careful2invest on Feb 10, 2017 1:15:48 GMT -5
Dreamboat wrote...
"FDA is pretty darn restrictive. Go to the Afrezza.com website and look at the page on "outsulin". What is said there is likely right up to the limit of what they feel they can get away with. If they could say any of the other things like you'd wish in an TV advert, why aren't they already doing it on the web page.
Absolutely, they CANNOT use anecdotal patient results as is done with nutritional supplements with "your results may differ". Clinical benefits can only be stated if proven to be statistically significant in an FDA approved trial.
When it comes to FDA approved drugs, simply watch the TV commercials that run day and night. The lack of the things you are hoping to see for Afrezza isn't because they have bad ad agencies that are less creative than you are... it is because they are constrained by FDA."
End of quote.
Dreamboat, Just for the record, I do not claim to have a talent for creative advertising.
Nor do I claim know the rules for advertising an FDA approved drug, so I will ask in a different way...
MNKD has shown the pk graph that I am mentioning in many conference calls and various presentations
even after AFREZZA was approved by the FDA. Right?
So are they are allowed to do that?
My answer to that is yes, but am I wrong?
If so, what is the difference between making that claim in front of a group of people from various walks of life in a
seminar or doing the same in an ad?
MNKD includes this same information on a webcast that is available for public access at any given time for their consumption.
How is that not in violation of FDA Law, (as you are telling me) if making the identical claim in an ad for public consumption is in violation?
I am not trying to be a smart ass, it just does not make sense!
You pose the question " why aren't they already doing it on the web page"
I have watched the webcasts with the slides displying the pk graph generated from MNKD CORP web page under "webcasts" and from the "news and events" sections on the actual MNKD CORP website.
In addition, there are many aspects of social media that could help grow the market for AFREZZA.
MNKD should be exploiting all of them.
As well as spending the appropriate amount of money to efficiently and effectively promote AFREZZA.
Doesn't it seem odd to you that a drug as "life changing" (according to the head of the JDRF and many others)
and Revolutionary as AFREZZA actually is, that two plus years after an FDA approval, nearly everyone that you may mention AFREZZA to, has never even heard of it?
It just does not add up!
That needs to change!
GLTA TRUE LONGS!
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Post by dreamboatcruise on Feb 10, 2017 2:44:34 GMT -5
careful2investFDA controls marketing of FDA approved drugs. Information conveyed to medical professionals or the investor community does not have the same restrictions as the marketing material for the drug. That said, there is a pk graph on the website page I referenced. So they can and have used it in marketing, and I would see no reason they couldn't use it in TV advert. They couldn't go beyond the data and state that it has benefits because it mimics normal pancreas or that it results in lower A1c, etc.
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Post by scoy on Feb 10, 2017 2:52:53 GMT -5
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