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Post by dreamboatcruise on Mar 16, 2017 9:48:44 GMT -5
Occasionally I feel like beating my head against a wall. This gem by Research Driven Investing from Yahoo: The company made a presentation today at the ROTH Conference, where they reported on their current lead drug for diabetics, Alfreeza. It has an inhaler delivery system and it reports that early results are comparable to the de facto insulin injection drug for type 1 diabetics, Lantus.Really??? I was going to highlight the glaring error in this obviously well researched piece but I thought that would lose the impact. Non-inferior is non-inferior.
So what do you mean Aged? Tell me.
Peppy... you read to quickly... "Lantus". It's a long acting. No prandial is going to be comparable to a daily. Like saying an apple is comparable to an orange.
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Post by peppy on Mar 16, 2017 10:02:14 GMT -5
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Post by lojothehus on Mar 16, 2017 10:39:30 GMT -5
Are you 100% sure about what is allowed by the FDA? Anecdotal testimonies are simply people's experiences in their words; dosing instructions are already approved by the FDA; and news clips are news clips. This is NOT "marketing material," it's real life experiences captured on a website. FDA wouldn't be able to touch this. Yes, absolutely sure that a drug company cannot use anecdotal results in their marketing. A website for a drug created by the drug's manufacturer is considered marketing by the FDA. You may not think it should be, but they do. IF what you are proposing is allowed, would you not think that at least ONE drug company would be doing it? Do you think you have thought of a successful marketing strategy than NO ONE within the drug industry is smart enough to figure out? Can you point me to one print ad, TV ad or drug website that presents anecdotal clinical patient data? My conviction of my understanding of the FDA comes from 1) reading info on FDA website, 2) listening to people such as Matt (user here) that has spent a career in this industry and 3) the evidence I see from the tons upon tons of drug marketing that I see every single day. What is your conviction that I am wrong based upon? Where is your capitalized "NOT" and can't touch that coming from? If there is an open forum, the FDA could not prohibit or prevent a poster from sharing their real-life experience with the drug. I do not have a conviction that you are wrong, but I do believe that you are centering your information on traditional advertising. The "NOT" was to stress that employing my marketing strategy is NOT through traditional advertising. Let me ask you a question, have you ever gone on a forum or website and purchased something after reading another person's review of the product?
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Post by dreamboatcruise on Mar 16, 2017 11:07:15 GMT -5
Yes, absolutely sure that a drug company cannot use anecdotal results in their marketing. A website for a drug created by the drug's manufacturer is considered marketing by the FDA. You may not think it should be, but they do. IF what you are proposing is allowed, would you not think that at least ONE drug company would be doing it? Do you think you have thought of a successful marketing strategy than NO ONE within the drug industry is smart enough to figure out? Can you point me to one print ad, TV ad or drug website that presents anecdotal clinical patient data? My conviction of my understanding of the FDA comes from 1) reading info on FDA website, 2) listening to people such as Matt (user here) that has spent a career in this industry and 3) the evidence I see from the tons upon tons of drug marketing that I see every single day. What is your conviction that I am wrong based upon? Where is your capitalized "NOT" and can't touch that coming from? If there is an open forum, the FDA could not prohibit or prevent a poster from sharing their real-life experience with the drug. I do not have a conviction that you are wrong, but I do believe that you are centering your information on traditional advertising. The "NOT" was to stress that employing my marketing strategy is NOT through traditional advertising. Let me ask you a question, have you ever gone on a forum or website and purchased something after reading another person's review of the product? If the forum is independently operated you are absolutely correct. I would even suspect that it could be allowed for MNKD to put an advert on such a forum as long as they weren't the ones running it. For instance if tudiabetes.org had a discussion about Afrezza and they accepted display advertising that might be a way of doing that. However, in that case you could also have people posting bad things... "it didn't work well for me", "I wouldn't dare put that stuff in my LUNGS", etc. I'm very certain MNKD couldn't run their own forum where they exerted editorial control and only put anecdotal information that was positive. I don't know all the ins and outs, however, I would say I'm not merely talking about "traditional advertising"... I'm talking about marketing in the broader sense and in general I don't assume that ALL the other drug companies in the world have marketing people that are 80 years old, using flip phones and simply lack knowledge of current marketing. I do tend to assume that if no other drug company is doing something, it is very likely that the FDA doesn't allow it. It will be very interesting what comes of the reality TV series. We know MNKD is working through issues with FDA on that. They are just sponsoring the show, not producing it, but that still seems to be an area they feel they need to ask permission.
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Post by babaoriley on Mar 16, 2017 13:27:27 GMT -5
That's a pretty good ad. It isn't doing any of the things disallowed by FDA, just raising the issue of injection vs not in attention getting way. Too bad Mannkind didn't hire that ad agency 9 months ago. Maybe we need to do one featuring a cactus... perhaps some metaphor of being lost in the desert surrounded by needle covered cacti (I know perfect spot to film that in Joshua Tree)... or maybe just steal the porcupine. I do like the "unjection" better than "outsulin." So that drug is for (non-human) animals that live, at least part time, in the water? Or does it work on humans, too? Bottom line, very good ad!
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Post by lojothehus on Mar 16, 2017 13:45:48 GMT -5
If there is an open forum, the FDA could not prohibit or prevent a poster from sharing their real-life experience with the drug. I do not have a conviction that you are wrong, but I do believe that you are centering your information on traditional advertising. The "NOT" was to stress that employing my marketing strategy is NOT through traditional advertising. Let me ask you a question, have you ever gone on a forum or website and purchased something after reading another person's review of the product? If the forum is independently operated you are absolutely correct. I would even suspect that it could be allowed for MNKD to put an advert on such a forum as long as they weren't the ones running it. For instance if tudiabetes.org had a discussion about Afrezza and they accepted display advertising that might be a way of doing that. However, in that case you could also have people posting bad things... "it didn't work well for me", "I wouldn't dare put that stuff in my LUNGS", etc. I'm very certain MNKD couldn't run their own forum where they exerted editorial control and only put anecdotal information that was positive. I don't know all the ins and outs, however, I would say I'm not merely talking about "traditional advertising"... I'm talking about marketing in the broader sense and in general I don't assume that ALL the other drug companies in the world have marketing people that are 80 years old, using flip phones and simply lack knowledge of current marketing. I do tend to assume that if no other drug company is doing something, it is very likely that the FDA doesn't allow it. It will be very interesting what comes of the reality TV series. We know MNKD is working through issues with FDA on that. They are just sponsoring the show, not producing it, but that still seems to be an area they feel they need to ask permission. I agree, I just believe that they have to get the news about Afrezza to the people or should I say to the common patients. Once they get some exposure to this drug, the rest will follow.
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Post by agedhippie on Mar 16, 2017 14:25:34 GMT -5
If there is an open forum, the FDA could not prohibit or prevent a poster from sharing their real-life experience with the drug. I do not have a conviction that you are wrong, but I do believe that you are centering your information on traditional advertising. The "NOT" was to stress that employing my marketing strategy is NOT through traditional advertising. Let me ask you a question, have you ever gone on a forum or website and purchased something after reading another person's review of the product? If the forum is independently operated you are absolutely correct. I would even suspect that it could be allowed for MNKD to put an advert on such a forum as long as they weren't the ones running it. For instance if tudiabetes.org had a discussion about Afrezza and they accepted display advertising that might be a way of doing that. However, in that case you could also have people posting bad things... "it didn't work well for me", "I wouldn't dare put that stuff in my LUNGS", etc. I'm very certain MNKD couldn't run their own forum where they exerted editorial control and only put anecdotal information that was positive. That is correct. I worked on Usenet (a blast from the past!) back in it's very early days in the mid-80s and we had a lot of concern from universities who were acting as relays in Europe as to some of the content (the US was protected by the first amendment) and we spent a lot of effort getting various countries to agree that Usenet had common carrier protections provided we didn't tamper with the traffic. The lawyers in the forum have a better idea than I do but as I understand it if there is no editorial control common carrier protections will apply. If they attempted to regulate the speech they would lose the protection and the FDA would be all over them. Probably why nobody has done it - imagine Yahoo boards but worse.
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Post by peppy on Mar 16, 2017 14:57:39 GMT -5
That's a pretty good ad. It isn't doing any of the things disallowed by FDA, just raising the issue of injection vs not in attention getting way. Too bad Mannkind didn't hire that ad agency 9 months ago. Maybe we need to do one featuring a cactus... perhaps some metaphor of being lost in the desert surrounded by needle covered cacti (I know perfect spot to film that in Joshua Tree)... or maybe just steal the porcupine. Black box warning on Xeljanz, serious infection and malignancy. ( Afrezza, is bronchospasm.)
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Post by porkini on Mar 16, 2017 15:03:52 GMT -5
That's a pretty good ad. It isn't doing any of the things disallowed by FDA, just raising the issue of injection vs not in attention getting way. Too bad Mannkind didn't hire that ad agency 9 months ago. Maybe we need to do one featuring a cactus... perhaps some metaphor of being lost in the desert surrounded by needle covered cacti (I know perfect spot to film that in Joshua Tree)... or maybe just steal the porcupine. I do like the "unjection" better than "outsulin." So that drug is for (non-human) animals that live, at least part time, in the water? Or does it work on humans, too? Bottom line, very good ad! LOL - even the porcupine looked like it was in an aquarium, waterless of course!
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Post by agedhippie on Mar 16, 2017 16:55:37 GMT -5
That's a pretty good ad. It isn't doing any of the things disallowed by FDA, just raising the issue of injection vs not in attention getting way. Too bad Mannkind didn't hire that ad agency 9 months ago. Maybe we need to do one featuring a cactus... perhaps some metaphor of being lost in the desert surrounded by needle covered cacti (I know perfect spot to film that in Joshua Tree)... or maybe just steal the porcupine. Black box warning on Xeljanz, serious infection and malignancy. ( Afrezza, is bronchospasm.) You have to wonder at what point suppressing the auto-immune system seemed like a good idea. Is suppose if your arthritis is bad enough the trade off to avoid the pain may be worthwhile.
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Post by peppy on Mar 16, 2017 17:02:26 GMT -5
Black box warning on Xeljanz, serious infection and malignancy. ( Afrezza, is bronchospasm.) You have to wonder at what point suppressing the auto-immune system seemed like a good idea. Is suppose if your arthritis is bad enough the trade off to avoid the pain may be worthwhile. Pfizer has a ton of money for advertising. on that commercial there was no black box warning shown. I went to the package insert to look at the drug and there it was.
www.ispot.tv/ad/A4OU/xeljanz-xr-porcupine
perhaps I better look again the drug says moderate to severe. remember when people used to use aspirin, just a hole in the stomach.
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Post by babaoriley on Mar 16, 2017 17:04:04 GMT -5
Unamerican, Sports, I'm gonna report you!
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Post by porkini on Mar 16, 2017 17:08:04 GMT -5
You have to wonder at what point suppressing the auto-immune system seemed like a good idea. Is suppose if your arthritis is bad enough the trade off to avoid the pain may be worthwhile. Pfizer has a ton of money for advertising. on that commercial there was no black box warning shown. I went to the package insert to look at the drug and there it was.
www.ispot.tv/ad/A4OU/xeljanz-xr-porcupine
perhaps I better look again the drug says moderate to severe. remember when people used to use aspirin, just a hole in the stomach.
Black box was not visually shown, but they talked around it in a flowery sort of way while distracting you with pretty pictures of animals (non-human).
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Post by peppy on Mar 16, 2017 17:09:56 GMT -5
Unamerican, Sports, I'm gonna report you! Baba, it is none of my business as usual. Are you holding any MNKD?
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Post by babaoriley on Mar 17, 2017 1:01:37 GMT -5
I sure am, peppy, a full 200 shares! That is as a result of someone exercising a put option I sold long ago. But don't worry, I have lots more put options out there that will bring me more shares, mostly in January 2018, plus I have a lot of Jan 2019 $.50 calls (equivalent to $2.50 after the R/S). So, it's very much in my interest for the stock to go up, assuming that's what your curiosity is about.
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