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Post by dh4mizzou on Apr 23, 2019 6:34:53 GMT -5
Do we need more reps? I'd be happy if we could have more of them but not if they're from a "partner".
Partner = dilution...of revenue.
It may be possible to have a partnership deal that wasn't totally objectionable, but I don't know what that would look like. I'm unable to imagine it. That's my limitation, not anyone else's. I'm curious to hear/read what others might imagine. I was thinking recently of the Faberge 80s shampoo (with pure wheat germ and honey!) commercial with Heather Locklear where she says she "told two friends about it, and they each told two friends, and so on, and so on" indicating an exponential increase in interest in the product. And, I wondered, do insulin-taking diabetics have insulin-taking friends with whom they talk about their experiences with their insulin(s)? Insulin administration is a lot more complicated than shampoo. I am curious to know how influential testimony is as a form of advertising for Afrezza. Personal testimony is almost certainly the most convincing. Why else hold dinners with doctors describing their experiences? But, how frequently do insulin-taking diabetics talk with each other about their personal medication experiences? OK well Lauren just told me, and I posted it in the scripts thread, that every diabetic she talks to, and of course you know who she is, has not heard of it! she thinks we need more reps, more doctor education by those reps. And more commercials. Co-partnering with Dexcom or SENS would double our exposure and show Afrezza in real time. Not to mention putting more money in the reps pockets. Better educating the doctors.
I just wonder if it wouldn't be more cost effective to purchase the mailing list of a few well know Diabetes organizations/publications. Then do a mass mailing announcing that there's a new sheriff in town named Afrezza.
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Post by prcgorman2 on Apr 23, 2019 6:37:59 GMT -5
Responding to uvula...
Nope, I’m pretty sure CentralCoastInvestor is right that the longer Mannkind continues, the better the chances get that they and their investors will reap the rewards appropriate to the manufacture of the fastest-acting mealtime insulin that also does not require injection and with less worry of hypoglycemic events. The physics of Afrezza are not going away no matter what happens to Mannkind. The physics and the PWD experience with Afrezza are very stubborn facts. The question is will those facts ever amount to monumental success?
The answer to that question will be known, but is not now known to a certainty. That’s one of the reasons I spent some time investigating “fads” and “trends”. The fact that Afrezza (or any product really) needs and benefits from advertising is because buyers cannot buy what they are unaware of. And, there needs to be something appealing about the product, a positive differentiation. Awareness, and positive benefit differentiation are the keys. It is not just “build it and they will come”.
And so about awareness many of us are thankful for the TV DTC advertising. And we hope that Afrezza users and prescribing doctors tell other insulin-using diabetics (and prescribing doctors) about their experiences with Afrezza good or bad because the field is prepared. Afrezza is as good or better than hoped, and while the trend is positive, Afrezza can become a fad. And then we can comfortably scoff at suggestions of a “paltry” one billion dollars to buy Afrezza from Mannkind.
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Post by uvula on Apr 23, 2019 8:19:25 GMT -5
If I see a car commercial and I want to buy it I buy it. I don't need to first convince a doctor and an insurance company to give me permission to make the purchase.
If I want to produce a car commercial I can say almost anything I want and don't need govt approval.
Selling drugs is very difficult. Not sure any small company can do it by themselves. And it gets much harder when the drug is "non inferior" but not "superior" to other drugs. But I hope I'm wrong.
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Post by prcgorman2 on Apr 23, 2019 8:53:50 GMT -5
You bring up good and interesting points. Ironically, it is possible to buy insulin over the counter without a prescription. I don't know how common it is, but it is possible. (An article on this is available at www.medscape.com/viewarticle/909381)Even so, I don't know what it took for the over-the-counter insulin to get to that point. It would be AWESOME if that could be the case for Afrezza, and perhaps some day it will. I agree that the FDA does require TV DTC to be reviewed, but they do not review all forms of advertising, although I agree there are regulations about what can be said in advertising or while selling. And I agree that these are headwinds for Mannkind to tack through. Regardless, I continue to agree with CentralCoastInvestor's original premise that the longer Mannkind survives, the better their chances of achieving ultimate success.
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Post by mymann on Apr 23, 2019 9:19:31 GMT -5
Common sense, longer Mannkind survives the more disruptive. I been with Mannkind since 2008. Now I realize I won't make a profit on my investment. Just want my money back. Great product potential, worst Investment I have ever made.
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Post by ktim on Apr 23, 2019 9:30:15 GMT -5
You bring up good and interesting points. Ironically, it is possible to buy insulin over the counter without a prescription. I don't know how common it is, but it is possible. (An article on this is available at www.medscape.com/viewarticle/909381)Even so, I don't know what it took for the over-the-counter insulin to get to that point. It would be AWESOME if that could be the case for Afrezza, and perhaps some day it will. I agree that the FDA does require TV DTC to be reviewed, but they do not review all forms of advertising, although I agree there are regulations about what can be said in advertising or while selling. And I agree that these are headwinds for Mannkind to tack through. Regardless, I continue to agree with CentralCoastInvestor's original premise that the longer Mannkind survives, the better their chances of achieving ultimate success. The first versions of recombinant DNA insulins (human insulin) were deemed sufficiently similar to the pig derived insulin that they were accorded the same grandfather status of not being Rx. I highly doubt any new insulins would be switched to OTC. It really is something that should have doctor supervision.
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Post by prcgorman2 on Apr 23, 2019 11:07:17 GMT -5
Isn't Afrezza a recombinant DNA insulin (human insulin)?
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Post by ktim on Apr 23, 2019 11:14:16 GMT -5
Isn't Afrezza a recombinant DNA insulin (human insulin)? It is, but the delivery mechanism and being paired to TS means its pk/pd is nothing like when the same insulin is injected sub-q from solution. The FDA does not, and rightly so, consider Afrezza to be functionally equivalent to injected Humulin or Novolin. We don't either or else we wouldn't be invested in MNKD, presumably.
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Post by prcgorman2 on Apr 23, 2019 12:57:37 GMT -5
Hmmm, I would love if the case could be reopened as it were regarding insulin OTC in terms of use/safety profile of what is currently sold over the counter versus Afrezza. I'm not saying Dr.'s Castagna and Kendall need to put this on the agenda, but I really have to wonder if a well-funded study could clearly prove superiority.
I read a comment once from a poster saying that one of the doctors at the AdCom said that if the tables had been turned and the approval of RAA had been required to prove superiority to Afrezza, creating a regimen based on the PK/PD profile of Afrezza would have killed the PWDs using RAA. I may have messed that up, but I've seen multiple references to the comments having been made.
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Post by ktim on Apr 23, 2019 13:32:52 GMT -5
Hmmm, I would love if the case could be reopened as it were regarding insulin OTC in terms of use/safety profile of what is currently sold over the counter versus Afrezza. I'm not saying Dr.'s Castagna and Kendall need to put this on the agenda, but I really have to wonder if a well-funded study could clearly prove superiority. I read a comment once from a poster saying that one of the doctors at the AdCom said that if the tables had been turned and the approval of RAA had been required to prove superiority to Afrezza, creating a regimen based on the PK/PD profile of Afrezza would have killed the PWDs using RAA. I may have messed that up, but I've seen multiple references to the comments having been made. Bad decisions in the past to grandfather things in doesn't justify continuing on with bad policy. It doesn't matter if a study proves Afrezza is superior, that isn't the issue. The issue is that people taking insulin should be under doctor's supervision. If insulin had been invented after FDA started regulating prescriptions then no insulin would be OTC. Hopefully we do get larger studies that show superiority and hopefully at levels greater than the 0.5% A1c difference shown in One Drop trial or doctors more quickly start paying attention to time in range. Regardless, the FDA is not going to make Afrezza OTC. If there were some fairness doctrine in play, I'd imagine they'd much sooner require prescriptions for humulin and novolin. Granted my stance on it being bad to have insulins OTC is based on a notion that people have access to doctors, which I know isn't always the case. But unwise to simply make everything OTC due to that issue.
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Post by longliner on Apr 23, 2019 14:28:06 GMT -5
Hmmm, I would love if the case could be reopened as it were regarding insulin OTC in terms of use/safety profile of what is currently sold over the counter versus Afrezza. I'm not saying Dr.'s Castagna and Kendall need to put this on the agenda, but I really have to wonder if a well-funded study could clearly prove superiority. I read a comment once from a poster saying that one of the doctors at the AdCom said that if the tables had been turned and the approval of RAA had been required to prove superiority to Afrezza, creating a regimen based on the PK/PD profile of Afrezza would have killed the PWDs using RAA. I may have messed that up, but I've seen multiple references to the comments having been made. It's pretty telling isn't it? When your product kills at a similar dosage that the competition excels, I guess the safe (only) bet is to kill the competition!
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Post by prcgorman2 on Apr 23, 2019 15:36:18 GMT -5
Hmmm, I would love if the case could be reopened as it were regarding insulin OTC in terms of use/safety profile of what is currently sold over the counter versus Afrezza. I'm not saying Dr.'s Castagna and Kendall need to put this on the agenda, but I really have to wonder if a well-funded study could clearly prove superiority. I read a comment once from a poster saying that one of the doctors at the AdCom said that if the tables had been turned and the approval of RAA had been required to prove superiority to Afrezza, creating a regimen based on the PK/PD profile of Afrezza would have killed the PWDs using RAA. I may have messed that up, but I've seen multiple references to the comments having been made. Bad decisions in the past to grandfather things in doesn't justify continuing on with bad policy. It doesn't matter if a study proves Afrezza is superior, that isn't the issue. The issue is that people taking insulin should be under doctor's supervision. If insulin had been invented after FDA started regulating prescriptions then no insulin would be OTC. Hopefully we do get larger studies that show superiority and hopefully at levels greater than the 0.5% A1c difference shown in One Drop trial or doctors more quickly start paying attention to time in range. Regardless, the FDA is not going to make Afrezza OTC. If there were some fairness doctrine in play, I'd imagine they'd much sooner require prescriptions for humulin and novolin. Granted my stance on it being bad to have insulins OTC is based on a notion that people have access to doctors, which I know isn't always the case. But unwise to simply make everything OTC due to that issue. Ooh, now we've stumbled into an area where things really get interesting. I work with a bunch of people from other countries which do not have anywhere near the same restrictive regulatory practices. Not sure if they have an opioid epidemic and I wonder if Canada does where Tylenol3 is available OTC. Anyway, health care in general and medication too are both far cheaper. We know this too from our experience with Afrezza and Brazil and India expectations with respect to revenue.
As for "doctor supervision", how much supervision is there really? Most PWDs still don't have CGMs. And from what I can tell it is professional diabetes educators who provide the real care for self-treatment with insulin. That and other diabetics.
The more I think about it and the more we debate this, the more I think the case for Afrezza OTC improves.
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Post by ezrasfund on Apr 23, 2019 16:34:05 GMT -5
Hmmm, I would love if the case could be reopened as it were regarding insulin OTC in terms of use/safety profile of what is currently sold over the counter versus Afrezza. I'm not saying Dr.'s Castagna and Kendall need to put this on the agenda, but I really have to wonder if a well-funded study could clearly prove superiority. I read a comment once from a poster saying that one of the doctors at the AdCom said that if the tables had been turned and the approval of RAA had been required to prove superiority to Afrezza, creating a regimen based on the PK/PD profile of Afrezza would have killed the PWDs using RAA. I may have messed that up, but I've seen multiple references to the comments having been made. That is more or less correct. In fact it was a statistician from the FDA who challenged the methodology of the Phase 3 trial, asking if it was right that the insulin dosage for Afrezza was higher than the dosage for the control arm, saying in effect, more insulin lower HbA1c. It was a doctor on the panel who pointed out that those higher dosages of an RAA could be fatal.
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Post by falconquest on Apr 23, 2019 17:19:43 GMT -5
Responding to uvula... Nope, I’m pretty sure CentralCoastInvestor is right that the longer Mannkind continues, the better the chances get that they and their investors will reap the rewards appropriate to the manufacture of the fastest-acting mealtime insulin that also does not require injection and with less worry of hypoglycemic events. The physics of Afrezza are not going away no matter what happens to Mannkind. The physics and the PWD experience with Afrezza are very stubborn facts. The question is will those facts ever amount to monumental success? The answer to that question will be known, but is not now known to a certainty. That’s one of the reasons I spent some time investigating “fads” and “trends”. The fact that Afrezza (or any product really) needs and benefits from advertising is because buyers cannot buy what they are unaware of. And, there needs to be something appealing about the product, a positive differentiation. Awareness, and positive benefit differentiation are the keys. It is not just “build it and they will come”. And so about awareness many of us are thankful for the TV DTC advertising. And we hope that Afrezza users and prescribing doctors tell other insulin-using diabetics (and prescribing doctors) about their experiences with Afrezza good or bad because the field is prepared. Afrezza is as good or better than hoped, and while the trend is positive, Afrezza can become a fad. And then we can comfortably scoff at suggestions of a “paltry” one billion dollars to buy Afrezza from Mannkind. I would agree with the premise that the longer Mannkind continues, the more disruptive Afrezza will become. However, I disagree that investors will "reap the rewards" because that will depend on how much dilution is required to get Mannkind/Afrezza to that point now doesn't it? This is the principle reason for my exit. The cost of getting Afrezza to that disruptive stage may be very high and consequently less and less profitable for investors. Were the issued shares to remain constant one could make this claim. Absent of that, it is anyone's guess how "profitable" Mannkind will be for investors.
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Post by agedhippie on Apr 23, 2019 19:20:41 GMT -5
Hmmm, I would love if the case could be reopened as it were regarding insulin OTC in terms of use/safety profile of what is currently sold over the counter versus Afrezza. I'm not saying Dr.'s Castagna and Kendall need to put this on the agenda, but I really have to wonder if a well-funded study could clearly prove superiority. I read a comment once from a poster saying that one of the doctors at the AdCom said that if the tables had been turned and the approval of RAA had been required to prove superiority to Afrezza, creating a regimen based on the PK/PD profile of Afrezza would have killed the PWDs using RAA. I may have messed that up, but I've seen multiple references to the comments having been made. That is more or less correct. In fact it was a statistician from the FDA who challenged the methodology of the Phase 3 trial, asking if it was right that the insulin dosage for Afrezza was higher than the dosage for the control arm, saying in effect, more insulin lower HbA1c. It was a doctor on the panel who pointed out that those higher dosages of an RAA could be fatal. The doctor was right. Afrezza uses a lot more insulin to achieve the same result as RAA because inhalation is not a particularly effective delivery route (a lot never makes it to where it needs to go). If you look at the dose sizes in the earlier trial you will see far bigger doses compared with later trials. That is because the dose sizes now reflect the action of RAA, and not the quantity of insulin used. This makes titration far easier as the numbers are more like people are used to. Even now the Afrezza dose is roughly 75% of an RAA dose.
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