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Post by dreamboatcruise on Mar 15, 2017 13:23:18 GMT -5
How many times do people here need to say that most of this IS NOT ALLOWED by the FDA. No a1c, no dosing instructions beyond what is approved by FDA, no anecdotal testimonials, no links to news clips that contain material that wouldn't be allowed as marketing material. There is a good reason that pharmaceuticals are not the wild West of supplements and diet pills. 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?
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Post by dreamboatcruise on Mar 15, 2017 13:33:29 GMT -5
How many times do people here need to say that most of this IS NOT ALLOWED by the FDA. No a1c, no dosing instructions beyond what is approved by FDA, no anecdotal testimonials, no links to news clips that contain material that wouldn't be allowed as marketing material. There is a good reason that pharmaceuticals are not the wild West of supplements and diet pills. Just pointing out a current creative ad out for a different product that deals with RA - calls needles on the carpet from the get-go: www.ispot.tv/ad/A4OU/xeljanz-xr-porcupineThat'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.
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Post by LosingMyBullishness on Mar 15, 2017 14:02:09 GMT -5
Here's your solution, advertise the crap out of this. No Needles and better A1C's. Use the company's Website as an informational piece that includes interactive dosing instructions, testimonials, a forum, and links to news clips. Rappers in the past who couldn't get record deals, sold their cassettes right out of the trunks of their cars and once people got their ears on their music, they demanded it.....and the big record labels had no other choice but to come running. MNKD, sale Afrezza to the people and not to the doctors! This is what many said here before. My take was that MNKD believed that T1 do inform themselves but that T2 are mostly following obediently follow what the docs tell them (with the exception of diet and exercise). Problem is that most docs are risk averse and happy to follow established and profitable routes.
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Post by dreamboatcruise on Mar 15, 2017 14:33:13 GMT -5
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Post by saxcmann on Mar 15, 2017 15:39:55 GMT -5
"Problem is that most docs are risk averse and happy to follow established and profitable routes."
Very well said!
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Post by brentie on Mar 15, 2017 16:29:46 GMT -5
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Post by mnholdem on Mar 15, 2017 18:28:47 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? Actually, I do know of one. I own stock options for this one in my biotech portfolio - Amarin Pharma Inc [AMRN]. Here's an excerpt of last year's report, which is very interesting reading: The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA took the unprecedented step of settling the Amarin lawsuit,1 in which a federal district court previously granted a preliminary injunction that allowed Amarin to publish certain “truthful and non-misleading speech” promoting the off-label use of Amarin’s drug Vascepa. The FDA agreed to terms that not only gave considerable concessions to the relatively small pharmaceutical manufacturer, but the settlement may also pave the way for other pharmaceutical companies to negotiate off-label marketing issues with the FDA.Source: www.jw.com/another-successful-first-amendment-challenge-to-the-prohibition-of-off-label-promotion-for-fda-approved-drugs-part-two/
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Post by babaoriley on Mar 15, 2017 19:05:30 GMT -5
Hot stuff, Holdem, but AMRN? Really? Is Vascepa some sort of Italian sweet cream cheese or something? Crap, I looked at my portfolio and I have some, too. I think the advantage is you can keep Vascepa at elevated temperatures for a long time, and it won't spoil. Great for picnics, etc. Sold me on it, anyway.
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Post by bioexec25 on Mar 15, 2017 19:28:57 GMT -5
While we are drifting slightly in the thread, perhaps a collective short-list make-up call plays aimed at recovering a small portion of the millions lost on Mnkd by retails (don't care about bigs). Not completely serious of course but gosh has the past few years been something. I went back and read some of the 2014-2015 hopium. Wow. Just wow.
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Post by sportsrancho on Mar 15, 2017 20:10:56 GMT -5
I'm shorting Sears:-)
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Post by agedhippie on Mar 16, 2017 9:27:20 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.
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Post by rockstarrick on Mar 16, 2017 9:37:11 GMT -5
Wow, afrezza is now time released !! A basal and prandial Insulin all in one, no more shots !!! We're Rich $$$$$$$$
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Post by peppy on Mar 16, 2017 9:39:18 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.
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Post by dreamboatcruise on Mar 16, 2017 9:45:08 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? Actually, I do know of one. I own stock options for this one in my biotech portfolio - Amarin Pharma Inc [AMRN]. Here's an excerpt of last year's report, which is very interesting reading: The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA took the unprecedented step of settling the Amarin lawsuit,1 in which a federal district court previously granted a preliminary injunction that allowed Amarin to publish certain “truthful and non-misleading speech” promoting the off-label use of Amarin’s drug Vascepa. The FDA agreed to terms that not only gave considerable concessions to the relatively small pharmaceutical manufacturer, but the settlement may also pave the way for other pharmaceutical companies to negotiate off-label marketing issues with the FDA.Source: www.jw.com/another-successful-first-amendment-challenge-to-the-prohibition-of-off-label-promotion-for-fda-approved-drugs-part-two/There has been discussion of that in the past here on proboards. A few things I'd point out... - It isn't about anecdotal clinical patient results. Very different thing. On the face of it I would consider anecdotal results misleading... and I'm 100% certain the FDA does as well. Cherry picking results as weight loss pills do (with tiny disclaimer that "results may vary") is misleading. Good reason FDA does not allow this. Please let me know if you have knowledge of FDA regulated pharma drug that uses anecdotal results in marketing/advertising. - FDA sued them... so it isn't as if this is a settled, risk fee move marketing off label. Even that summary states "may also pave the way for other pharmaceutical companies to NEGOTIATE off-label marketing issues with the FDA". That would seem to imply the FDA isn't simply ceding that they don't go after off label marketing. If that summary is accurate it seems to imply the FDA is saying, "be very careful... we'd highly recommend getting our approval first". I would guess that a company would likely need some pretty strong evidence of efficacy to be considered non-misleading. Would the evidence need to be as strong as the FDA would typically require for a new indication? Maybe. Perhaps this is simply a way of short circuiting a lengthy approval, but the standard of evidence would still be the same. - You can win a lawsuit against the FDA sometimes, but that might not be the wisest thing to do if you are relying on things like label changes and approval of new APIs. Many feel that Al's past criticism/conflicts with FDA may have contributed to the poor treatment and delays Afrezza got from FDA. So the bottom line is that this ruling may give some leeway to MNKD, or maybe not. Would this allow them to market for pediatric use as long as they didn't mislead about lack of pediatric trials? Would it allow them to market for gestational diabetes? It most certainly wouldn't allow them to have Sam Finta on a TV comercial saying he lowered his A1c from X to Y. Matt has talked about the FDA restrictions. He isn't lying to us.
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Post by agedhippie on Mar 16, 2017 9:47:03 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.
The last word - Lantus. Lantus which is most definitely is not the de facto meal time insulin for Type 1 diabetics so how do they think it is comparable?
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