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Post by peppy on Jan 23, 2016 11:16:27 GMT -5
There has not been one TV commercial yet. In contrast to what so many have said since SNY partnered, Doctors do not necessarily need to be prepped to start a DTC program. Limited DTC TV campaign in a major metro market like LA at peak viewing hours. Show Diabetic using device to demonstrate simplicity. Fill the entire screen with the PK curve and compare it to the PK curve of the status quo prandial insulins. (Patients, MDs, PAs, parents of diabetics, etc.. will see); mention AFZ is a monomeric insulin.
State the inert nature of Techno and a brief video of how Techno delivers the insulin. Demonstrate the portability and convenience of the dreamboat. Stay humble in the presentation and present as a new option, which may reduce the number of daily injections. State Black Box warnings. State has been tested in over 6000 patients. Maybe incorporate and Endocrinologist in the video to narrate. Medical product lawyers may know if this is allowed. Regarding the PK curve, can it be said, Afrezza, a fast acting insulin monomer, stops blood glucose from going high in the first place. ?
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Post by suebeeee1 on Jan 23, 2016 11:18:25 GMT -5
Robert Sacher, Will you be writing an updated article based on everything that has happened and what your perspective is on the stock for other longs or new investors? Although I did like your articles on seeking, I assess my expectations for the company have soured considerably. I would recommend writing an article, especially since the hit pieces are out and they are bringing up some cogent points given available information. Yes. It's up today at Seeking Alpha: seekingalpha.com/article/3826966-mannkind-launches-new-direction-afrezzaRobert, Very good recap of the movement in the MNKD camp within the last three weeks. I like that you are a long and a true believer as well. Alas, that is not enough. However your article did manage to flesh out some ideas as to how to reach people through social media. There are some great points made and I certainly hope Alan does send Matt a proposal. This is perhaps the best use for seeking alpha articles. Thanks for taking the time to submit an articulate, well thought out, positive article!
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Post by suebeeee1 on Jan 23, 2016 11:22:04 GMT -5
There has not been one TV commercial yet. In contrast to what so many have said since SNY partnered, Doctors do not necessarily need to be prepped to start a DTC program. Limited DTC TV campaign in a major metro market like LA at peak viewing hours. Show Diabetic using device to demonstrate simplicity. Fill the entire screen with the PK curve and compare it to the PK curve of the status quo prandial insulins. (Patients, MDs, PAs, parents of diabetics, etc.. will see); mention AFZ is a monomeric insulin.
State the inert nature of Techno and a brief video of how Techno delivers the insulin. Demonstrate the portability and convenience of the dreamboat. Stay humble in the presentation and present as a new option, which may reduce the number of daily injections. State Black Box warnings. State has been tested in over 6000 patients. Maybe incorporate and Endocrinologist in the video to narrate. Medical product lawyers may know if this is allowed. Regarding the PK curve, can it be said, Afrezza, a fast acting insulin monomer, stops blood glucose from going high in the first place. ?
Really, it would seem that no words are necessary. Just these graphs. No other claims need to be made. Even a moron could extrapolate the superiority of Afrezza. What does that make Sanofi?
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Post by agedhippie on Jan 23, 2016 11:27:25 GMT -5
Really, it would seem that no words are necessary. Just these graphs. No other claims need to be made. Even a moron could extrapolate the superiority of Afrezza. What does that make Sanofi? It is two different things. Those show the PD/PK from the clamp test, and the trial results say even so in the trials the results are no better. The trial data trumps the clamp test.
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Post by peppy on Jan 23, 2016 11:49:45 GMT -5
Really, it would seem that no words are necessary. Just these graphs. No other claims need to be made. Even a moron could extrapolate the superiority of Afrezza. What does that make Sanofi? It is two different things. Those show the PD/PK from the clamp test, and the trial results say even so in the trials the results are no better. The trial data trumps the clamp test.aged, even with the trial trump, Any chance it can be said, commercial advertisement, Afrezza, A fast acting insulin monomer, stops blood glucose levels from going so high in the first place. ??
To my brain cells, that is huge. Additionally in the trials there was less hypoglycemia, proven,
If Afrezza could say, "Afrezza a inhalable fast acting insulin monomer stops glucose from going high in the first place with less hypoglycemia." ?
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Post by od on Jan 23, 2016 11:53:00 GMT -5
Physicians can not keep up with all the medications. Drug reps do not enjoy the same access or clout with physicians that they once did. IMO, the importance of Pharmaceutical Reps has precipitously dropped. Hence, DTC campaigns have become increasingly important over the last 15 yrs. As someone who has worked in the medical profession for over 20 years, when I look back to the 90s for example, when reps would routiniely come by the hospital or outpatient office, sponsor lunches or conferences, make formal presentations to an individual group, etc... this is simply not the case anymore. 'We call them' now when we are compelled to get more info on a particular product, hence the importance of DTC campaigns. Some medical groups send one or two of their physicians to their top respective conferences to get the latest info on technology and advancements, for example ASCO (American Society of Clinical Oncology) . But it is nearly impossible to keep up with all the drugs in development, and once a new drug is approved , how to utilize and incorporate that product into your practice is another significant task. Lets not forget that the practices are burdened with voluminous regulations that seem to grow every year. Lets take SNY's current Toujeo commercials, while Endos may be getting updates and presentations on the differences of this Insulin, most prescribing physicians i.e. Primary Care MDs, will hear about Toujeo for the first time from the DTC TV ads or via patients, and not from a SNY rep. Its that simple. In a nut shell, consumer centric demand is the path to create the greatest interest in AFZ IMO. I don't disagree with your thinking, but would you agree that if there had been a carefully executed, traditional launch, starting years before approval, that Afrezza would be on its way to blockbuster status? I don't think it fair to compare Afrezza to Toujeo, a product in a category as familiar to physicians as any. Yes, DTC for Toujeo is the way to go. I believe it would be almost impossible for a provider to push-back on a patient's request for Toujeo -- not very difficult for those unfamiliar/uncomfortable with Afrezza to convince a patient that it was 'too early'. I think the number of patients that would demand Afrezza or change physicians is very small. All that aside, there is still the current issue of formulary status. Re: the importance of Pharmaceutical Representatives, I have mixed feelings - in the case of Afrezza, I believe reps would have had an impactful role in a fully executed/integrated launch. To try to keep up with 21st century realities many practices and manufacturers are embracing RxVantage type models.
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Post by pktrump on Jan 23, 2016 11:58:05 GMT -5
Suebeee1,
What does that make Sanofi?
Negligent.
Regarding the PK profile and DTC advertisement:
Start with graph of natural phase I insulin response followed by overlaying AFZ PK profile. Don't need to say much, other than the word "natural".
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Post by pktrump on Jan 23, 2016 12:12:59 GMT -5
Od
Not sure I know what a traditional launch is anymore, but yes to your first question that we would be way ahead of where we are today.
Regarding comparing to Toujeo as unfair, I respectively disagree: the essence of DTC is to increase awareness. Because Toujeo is more familiar to prescribing Docs given its similarity to Lantus is exactly the reason why DTC is even more important, IMO mandatory, in the case of AFZ.
To maintain the status quo is the least path of resistance for SNY and Physicians. To change requires substantially more effort on many fronts.
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Post by peppy on Jan 23, 2016 12:20:31 GMT -5
Suebeee1, What does that make Sanofi? Negligent. Regarding the PK profile and DTC advertisement: Start with graph of natural phase I insulin response followed by overlaying AFZ PK profile. Don't need to say much, other than the word "natural". "Afrezza, a fast acting insulin monomer, stop blood glucose levels from going high in the first place, with less hypoglycemia."
(The first phase insulin response is not seen with hexamer fast acting analogs)
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Post by bioexec25 on Jan 23, 2016 12:20:32 GMT -5
Sue,Pk - Imo makes Sny wickedly wise. They took a year off the product lifecycle of Afrezza mostly guarded legally by a "education first", "slow roll strategy", got their Lantus replacement launched and established without letting Afrezza remotely move in on share. Heck they even managed with a little help to leave Mnkd nearly bankrupt. I'd say that is pretty good going if your goal is to protect billions and billions in existing or planned organic diabetes franchise revenues. Lastly somehow managed to have GSCO through connections absolutely do their bidding on the biz front. All of this of course on the heels of a tough label and pretty long lousy road to original approval by the FDA. Yep the bastar%s did well, all too well if you are a shareholder or patient in need of such a great drug as Afrezza.
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Post by peppy on Jan 23, 2016 12:26:01 GMT -5
Suebeee1, What does that make Sanofi? Negligent. Regarding the PK profile and DTC advertisement: Start with graph of natural phase I insulin response followed by overlaying AFZ PK profile. Don't need to say much, other than the word "natural". "Afrezza, a fast acting insulin monomer, stop blood glucose levels from going high in the first place, with less hypoglycemia."
(The first phase insulin response is not seen with hexamer fast acting analogs)
Which bring back the question, The physicians can see this.
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Post by mnkdorbust on Jan 23, 2016 13:23:19 GMT -5
I think a simple explanation of Monomer vs hexamer and illustration of how your body breaks down the hexamer would be good for the public. Simplify it as much as possible. Why would you want to use this when you can use this which is doing exactly what a healthy pancreas does.
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Post by agedhippie on Jan 23, 2016 13:47:53 GMT -5
It is two different things. Those show the PD/PK from the clamp test, and the trial results say even so in the trials the results are no better. The trial data trumps the clamp test. aged, even with the trial trump, Any chance it can be said, commercial advertisement, Afrezza, A fast acting insulin monomer, stops blood glucose levels from going so high in the first place. ??
To my brain cells, that is huge. Additionally in the trials there was less hypoglycemia, proven,
If Afrezza could say, "Afrezza a inhalable fast acting insulin monomer stops glucose from going high in the first place with less hypoglycemia." ? I don't think you can say that unless its published in a peer reviewed journal because you are making a medical claim. Even then it suffers from the same problem as talking about hexamers and monomers. That's a quick way to lose an audience in seconds. They want to know what's in it for them - as for how or why it works they really don't care. I think there should be an angle we can use out there, I just cannot see it right now which is frustrating. I feel the doctors are key to this because right now they seem to be negative about it so maybe they should be the advertising target. You can advertise to the public but that gives you a minute to pitch and the doctor 15 minutes to refute. You can guess how that ends! We need the doctors.
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Post by od on Jan 23, 2016 14:12:41 GMT -5
Od Not sure I know what a traditional launch is anymore, but yes to your first question that we would be way ahead of where we are today. Regarding comparing to Toujeo as unfair, I respectively disagree: the essence of DTC is to increase awareness. Because Toujeo is more familiar to prescribing Docs given its similarity to Lantus is exactly the reason why DTC is even more important, IMO mandatory, in the case of AFZ. To maintain the status quo is the least path of resistance for SNY and Physicians. To change requires substantially more effort on many fronts. I agree re: 'traditional launch'; perhaps 'properly/better commercialized' is better. If Afrezza was a SNY (or NVS or PFE or LLY or...) developed product, there would have been multiple teams preparing the launch years in advance. Trials would have been designed with labeling in mind, pre-launch would have included a publication/education plan... - the essential blocking and tackling.
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Post by peppy on Jan 23, 2016 14:32:17 GMT -5
Robert Sacher, Will you be writing an updated article based on everything that has happened and what your perspective is on the stock for other longs or new investors? Although I did like your articles on seeking, I assess my expectations for the company have soured considerably. I would recommend writing an article, especially since the hit pieces are out and they are bringing up some cogent points given available information. Yes. It's up today at Seeking Alpha: seekingalpha.com/article/3826966-mannkind-launches-new-direction-afrezzaQuote from, MannKind Launches New Direction For Afrezza. Receptor Life Sciences, whereby "multiple inhaled therapeutic products will be developed to explore their potential to treat conditions such as chronic pain, neurologic diseases and inflammatory disorders."
Conventional treatment for the list of inflammatory diseases
Prednisolone Sulfasalazine Methotrexate Hydroxychloroquine Etanercept Infliximab Adalimumab
www.progesteronetherapy.com/list-of-inflammatory-diseases.html#axzz3y5jkpHCd --------------------------------------------------------------------------------------------------
1. HUMIRA® (adalimumab) Adalimumab injection comes as a solution (liquid) to inject subcutaneously (under the skin). It is usually injected once every other week.
2. Infliximab injection is used to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including:
Infliximab injection is in a class of medications called tumor necrosis factor-alpha (TNF-alpha) inhibitors. It works by blocking the action of TNF-alpha, a substance in the body that causes inflammation. ------------------------------------------------------------------------------------------------------------------------------- Epilepsy is a neurologic disease.
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