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Post by dreamboatcruise on Jan 19, 2016 11:31:51 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. Without some concrete info from MNKD, it seems the shorts are the ones with the credibility. They got it right and the longs got it wrong. The 10,000 ft view that people will perceive is that MNKD doesn't release much info and that somehow the shorts are plugged into what is really happening and the longs are delusional. I was and am trying to be less so... delusional that is, not less long. Sorry for the frank assessment. The refutation of the shorts at this point will need to come from real info out of MNKD, not more that will seem wishful thinking. In the meantime, the beatings will continue.
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Post by LosingMyBullishness on Jan 19, 2016 11:33:54 GMT -5
A dedicated afrezza YouTube channel that showcases real users and their specific afrezza usage, challenges and benefis. This is to get a ' that's-me' experience and some good advice along the first weeks of usage. Very cheap. Needs a good presenter to help the diabetics who showcases their situation to feel comfortable. Second you need a celebrity that is a diabetic and works for broad audience. Most people see this with guy like Tom Hanks. If this person understands Afrezza and MNKD's situation as underdog this could be less expensive. One problem with freewheeling out of the box thinking is that a lot of it may well be out of the box allowed by the FDA. For instance, while an individual user can't be prohibited from posting something about their use of Afrezza (if they aren't making money from it), MNKD is constrained in what they can do to market Afrezza. You'll notice a stark contrast in TV ads from supplement companies not regulated by FDA and those from drug companies. Rules/laws allow a supplement company to show the 4 people that lost tons of weight with a barely noticeable disclaimer at the bottom that admits it isn't scientific and may not be typical. A drug company cannot use anecdotal information in marketing... that is why you don't see that in drug ads and there is almost always language like "xyz MAY help blah, blah, blah". You never see someone say "it was the greatest, my blah, blah cleared up in a week". If the clinical trials really have the statistical proof, a company might be able to go so far as to say "xyz helps reduce blah, blah within a week for most patients"... but there has to be the clinical trials, not anecdotal. You could pay for a celebrity (and we don't have the money for Tom Hanks), but they still couldn't endorse the product using their anecdotal experience with it. Youtub doesn't change the rules about what MNKD can do in marketing material. Understood. But this does not limit a small team to set up a channel and invite users to share their own experience.
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Post by LosingMyBullishness on Jan 19, 2016 11:45:40 GMT -5
One problem with freewheeling out of the box thinking is that a lot of it may well be out of the box allowed by the FDA. For instance, while an individual user can't be prohibited from posting something about their use of Afrezza (if they aren't making money from it), MNKD is constrained in what they can do to market Afrezza. You'll notice a stark contrast in TV ads from supplement companies not regulated by FDA and those from drug companies. Rules/laws allow a supplement company to show the 4 people that lost tons of weight with a barely noticeable disclaimer at the bottom that admits it isn't scientific and may not be typical. A drug company cannot use anecdotal information in marketing... that is why you don't see that in drug ads and there is almost always language like "xyz MAY help blah, blah, blah". You never see someone say "it was the greatest, my blah, blah cleared up in a week". If the clinical trials really have the statistical proof, a company might be able to go so far as to say "xyz helps reduce blah, blah within a week for most patients"... but there has to be the clinical trials, not anecdotal. You could pay for a celebrity (and we don't have the money for Tom Hanks), but they still couldn't endorse the product using their anecdotal experience with it. Youtub doesn't change the rules about what MNKD can do in marketing material. Understood. But this does not limit a small team to set up a channel and invite users to share their own experience. If I were a diabetic I would rather trust the testimony of 200 other diabetics than any ad with some healthy actors and a smooth voice from the off. As a doctor I would also rather believe these testimonies than any sales rep. And as an afrezza user I would try to help MNKD to survive.
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Post by coo2002coo on Jan 19, 2016 11:46:26 GMT -5
Yeah. So maybe we can start with those in the US & see if we can replicate the model in other countries later on. Can you do that? I think it's a HIPAA violation, and probably an ethics violation as well. Just because you are on a trial it doesn't give anyone the right to market to you. It would definitely be a breach of the EU privacy directive (data may only be used for the purpose for which it was given, and marketing was not the reason) in the EU and some of the trial patients were in Germany I think. I am sure there must be ways to get around legitimately. It may take more than a couple of steps to get those patients to agree commercial solicitation first before any invitation. Just my 2 cents here.
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Post by dreamboatcruise on Jan 19, 2016 12:05:21 GMT -5
Understood. But this does not limit a small team to set up a channel and invite users to share their own experience. Users good easily do that. It is unlikely to be something MNKD would initiate. Likewise MNKD probably would be allowed to reference the site or provide links to it. I can't say with 100% certainty where the lines would be, but I don't think the fact that drug companies lack these sorts of campaigns has to do with them being unaware of the possibilities. Maybe the lines are still not fully tested and MNKD will push envelopes, but in doing so they risk having the FDA come down on them... and this is the same FDA they will need to be on good terms with for future clinical trials.
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Post by dreamboatcruise on Jan 19, 2016 12:13:56 GMT -5
Understood. But this does not limit a small team to set up a channel and invite users to share their own experience. If I were a diabetic I would rather trust the testimony of 200 other diabetics than any add with f#% actors and a smooth voice from the off. As a doctor I would also rather believe these testimonies than any sales rep. And a an afrezza user I would try to help MNKD to survive. Adverts aren't going to have 200 people. Do you trust every commercial that you see with one or a few people with some miraculous results? Would you trust a youtube channel for a miracle diet pill if they had 200 people give testimonials but you knew the website was owned and operated by the company that made the pills? Despite not serving Afrezza well, the FDA rules with regard to drugs are appropriate. People waste tons and tons of money (and in some cases endanger their health) because of the loose regulation of supplements that allow a few anecdotal results to be presented. We know Afrezza is a great drug, but the rules about marketing have to apply evenly to the good drugs and the not so good that may be marketed by the unscrupulous.
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Post by esstan2001 on Jan 19, 2016 12:43:41 GMT -5
If I were a diabetic I would rather trust the testimony of 200 other diabetics than any add with f#% actors and a smooth voice from the off. As a doctor I would also rather believe these testimonies than any sales rep. And a an afrezza user I would try to help MNKD to survive. Adverts aren't going to have 200 people. Do you trust every commercial that you see with one or a few people with some miraculous results? Would you trust a youtube channel for a miracle diet pill if they had 200 people give testimonials but you knew the website was owned and operated by the company that made the pills? Despite not serving Afrezza well, the FDA rules with regard to drugs are appropriate. People waste tons and tons of money (and in some cases endanger their health) because of the loose regulation of supplements that allow a few anecdotal results to be presented. We know Afrezza is a great drug, but the rules about marketing have to apply evenly to the good drugs and the not so good that may be marketed by the unscrupulous. Was I dreaming, or was there some decision that a drug company could make claims as long as they knew them to be 100% factual; wasn't there some court case that permitted the company to make the claims and assume the risk or being wrong in the eyes of the FDA? I would think Mannkind would not want to be a guinea pig on this edge of the legal envelope issue, but maybe there are some hypo / speed superiority claims that can be made, assuming some smaller, affiliated clinical practices run some 3-6 month studies to validate the proper dose timing, etc. Get the data published / presented ASAP, while not an FDA run trial, the question is whether it could be used to make some type of claims... on results that are easier to demonstrate stat sig for.
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Post by LosingMyBullishness on Jan 19, 2016 12:53:41 GMT -5
dreamboat, MNKD has a problem that needs to be solved. This means that things need to be done differently. Different to what SNY did, which played it very cautiously. So you really meant that setting up a youtube channel by afrezza users (as this is what I said, I did not said that is is owned and run by MNKD), this would be an issue with the FDA? If so, than MNKD would have had already some visits from the FDA, as there are already some testimonies from users. I do not really understand your line of thought, I guess.
So I believe that the reward is much bigger than the risk. Right now the youtube videos lack an umbrella, a skilled presenter and a small production group. There are zillions of small production groups out there that started with a small set up (like good mystical morning). My understanding was that this thread is about collecting ideas. It is not about killing ideas right when they come up. But what ever. I would go for that and you don't. Let's leave it like that.
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Post by karma2 on Jan 19, 2016 16:33:58 GMT -5
Give dreamboat into the hands of El Chappo et al...we'll have all data we need for dosing of everything and anything...
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Post by dreamboatcruise on Jan 19, 2016 19:29:58 GMT -5
dreamboat, MNKD has a problem that needs to be solved. This means that things need to be done differently. Different to what SNY did, which played it very cautiously. So you really meant that setting up a youtube channel by afrezza users (as this is what I said, I did not said that is is owned and run by MNKD), this would be an issue with the FDA? If so, than MNKD would have had already some visits from the FDA, as there are already some testimonies from users. I do not really understand your line of thought, I guess. So I believe that the reward is much bigger than the risk. Right now the youtube videos lack an umbrella, a skilled presenter and a small production group. There are zillions of small production groups out there that started with a small set up (like good mystical morning). My understanding was that this thread is about collecting ideas. It is not about killing ideas right when they come up. But what ever. I would go for that and you don't. Let's leave it like that. Users are free to do anything as long as they aren't trying to make money off of promoting the drugs. What I thought I had said clearly was that MNKD cannot use anecdotal info in THEIR marketing... and likely couldn't even link to it if done as part of a marketing campaign. I don't believe they have done so... hence no visits from FDA at this point. Hopefully there is some way users might be able to have a forum and MNKD provide some links to that... and of course any discussion forum would likely have much positive said about Afrezza. I'd be really interested in whether anyone is aware of other drug companies that have managed to officially support or associate with users forums for their drugs. SNY had Afrezza Hub (pretty lame)... but then they never seemed to post anything. Did all our early adopter users simply not go there to try to post? Did SNY reject them? Were these FDA barriers the reason? I'm all for exploring things, but ignoring realities isn't the best strategy in brainstorming. Maybe MNKD does some envelop pushing and perhaps they should... but there is no way we are going to see ads paid for by MNKD with Sam showing his CGM.
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gz
Newbie
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Post by gz on Jan 19, 2016 19:44:43 GMT -5
I e-mailed "I f'ing love science." I didn't want to email Matt in case it is not allowed by the FDA or whatever. Hopefully they find Afrezza a good product to write an article on for their viewers. Looking at their website, they do have a section for Health/Medicines. Maybe if others email them they'll see more people are interested in Afrezza and will make them more inclined to write something...?
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gz
Newbie
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Post by gz on Jan 19, 2016 19:55:35 GMT -5
Maybe someone with some more knowledge and better writing skills than me can write a short letter and post it here. I don't mind emailing other websites & Facebook pages to see if they'll do an article. Something that really grabs the writer and makes them believe it is a good product to write about. Thanks!
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Post by dreamboatcruise on Jan 19, 2016 21:25:23 GMT -5
Adverts aren't going to have 200 people. Do you trust every commercial that you see with one or a few people with some miraculous results? Would you trust a youtube channel for a miracle diet pill if they had 200 people give testimonials but you knew the website was owned and operated by the company that made the pills? Despite not serving Afrezza well, the FDA rules with regard to drugs are appropriate. People waste tons and tons of money (and in some cases endanger their health) because of the loose regulation of supplements that allow a few anecdotal results to be presented. We know Afrezza is a great drug, but the rules about marketing have to apply evenly to the good drugs and the not so good that may be marketed by the unscrupulous. Was I dreaming, or was there some decision that a drug company could make claims as long as they knew them to be 100% factual; wasn't there some court case that permitted the company to make the claims and assume the risk or being wrong in the eyes of the FDA? I would think Mannkind would not want to be a guinea pig on this edge of the legal envelope issue, but maybe there are some hypo / speed superiority claims that can be made, assuming some smaller, affiliated clinical practices run some 3-6 month studies to validate the proper dose timing, etc. Get the data published / presented ASAP, while not an FDA run trial, the question is whether it could be used to make some type of claims... on results that are easier to demonstrate stat sig for. It was last year and in district court and at the time thought to be subject to appeal by FDA to Supreme Court. It was a company that had a valid scientific clinical trial for off-label use but didn't get FDA approval. Even if that is upheld I can't imagine that totally strips the FDA of their role in making standards about what is misleading and what isn't. I think they would still deem anecdotal stories as scientifically misleading. They force listing all the side effects because they demand balance as part of being non misleading. If you're showing individuals with the good results do you not think the balance would demand showing people that suffered the adverse effects? But if MNKD really wanted to stick their neck out the way to do it would be as you state. Do a short non-FDA sanctioned trial, and have marketing that does a very fair, sober representation of the trial data.
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Post by nylefty on Jan 19, 2016 22:35:40 GMT -5
Was I dreaming, or was there some decision that a drug company could make claims as long as they knew them to be 100% factual; wasn't there some court case that permitted the company to make the claims and assume the risk or being wrong in the eyes of the FDA?
It was last year and in district court and at the time thought to be subject to appeal by FDA to Supreme Court. It was a company that had a valid scientific clinical trial for off-label use but didn't get FDA approval. Even if that is upheld I can't imagine that totally strips the FDA of their role in making standards about what is misleading and what isn't. I think they would still deem anecdotal stories as scientifically misleading. They force listing all the side effects because they demand balance as part of being non misleading. If you're showing individuals with the good results do you not think the balance would demand showing people that suffered the adverse effects? There are other judicial layers this decision would have to go through before the case would go to the supreme court. The initial decision was handed down by a lone district judge in New York City. The FDA could appeal to a panel of judges in the same district and/or the circuit court of appeals for that district -- all of which could put off a final decision for years.
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Post by esstan2001 on Jan 19, 2016 23:17:25 GMT -5
Was I dreaming, or was there some decision that a drug company could make claims as long as they knew them to be 100% factual; wasn't there some court case that permitted the company to make the claims and assume the risk or being wrong in the eyes of the FDA? I would think Mannkind would not want to be a guinea pig on this edge of the legal envelope issue, but maybe there are some hypo / speed superiority claims that can be made, assuming some smaller, affiliated clinical practices run some 3-6 month studies to validate the proper dose timing, etc. Get the data published / presented ASAP, while not an FDA run trial, the question is whether it could be used to make some type of claims... on results that are easier to demonstrate stat sig for. It was last year and in district court and at the time thought to be subject to appeal by FDA to Supreme Court. It was a company that had a valid scientific clinical trial for off-label use but didn't get FDA approval. Even if that is upheld I can't imagine that totally strips the FDA of their role in making standards about what is misleading and what isn't. I think they would still deem anecdotal stories as scientifically misleading. They force listing all the side effects because they demand balance as part of being non misleading. If you're showing individuals with the good results do you not think the balance would demand showing people that suffered the adverse effects? But if MNKD really wanted to stick their neck out the way to do it would be as you state. Do a short non-FDA sanctioned trial, and have marketing that does a very fair, sober representation of the trial data. Something else I was wondering about, that may help here- FDA maintains a Log of reported adverse patient events... Anyone seen the Afrezza reports, if they are as clean as I suspect (a few coughing issues) doesn't the FDA take that into consideration when a request for label revision is made? Is Mnkd at the point where this can be pursued? Afrezza has been available now just about 1 year now.
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