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Post by stevil on Jan 8, 2019 22:43:49 GMT -5
I’m with vdex. I don’t see hockey stick in the near future. Consumers will not drive that type of growth. Every doctor I’ve spoken to that knows about Afrezza has told me it’s unsafe, ineffective, and “expensive garbage.” It would take patients demanding Afrezza from doctors and that rarely ever happens. No ad campaign will change that. If you want hockey stick growth, you need to win the doctors over. That’s the only way forward to exponential growth- once they have great success or are shown the road to success. Stevil - EVERY doctor? I highly, highly doubt this. How many doctors have you spoken to? Yes, every doctor I’ve spoken to that had heard of Afrezza. I have not yet run into a prescriber of Afrezza. On the flip side, the blank slates I’ve talked to, the ones I get to make the first impression on, say they’re impressed and they’ll follow the story once it gets better insurance coverage. The presentation I gave generated a lot of interest because I got to present Afrezza the right way. I showed why a faster insulin was needed by showing how much more area is under the curve of RAAs, why postprandial excursions are so vital to A1c, and how Afrezza could radically transform treatment with its tight control. I’ve probably spoken to 30 or so doctors about Afrezza. I’d say around 40% had heard of it. So, around 12 gave that opinion. I have yet to meet a doctor who both had heard of Afrezza and had a high opinion of it. Which is a shame because a couple were really interested in diabetes treatment and spent considerable time researching Afrezza. They came away unimpressed with the data that’s floating around out there. |
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Post by peppy on Jan 8, 2019 22:57:24 GMT -5
Stevil - EVERY doctor? I highly, highly doubt this. How many doctors have you spoken to? Yes, every doctor I’ve spoken to that had heard of Afrezza. I have not yet run into a prescriber of Afrezza. On the flip side, the blank slates I’ve talked to, the ones I get to make the first impression on, say they’re impressed and they’ll follow the story once it gets better insurance coverage. The presentation I gave generated a lot of interest because I got to present Afrezza the right way. I showed why a faster insulin was needed by showing how much more area is under the curve of RAAs, why postprandial excursions are so vital to A1c, and how Afrezza could radically transform treatment with its tight control. I’ve probably spoken to 30 or so doctors about Afrezza. I’d say around 40% had heard of it. So, around 12 gave that opinion. I have yet to meet a doctor who both had heard of Afrezza and had a high opinion of it. Which is a shame because a couple were really interested in diabetes treatment and spent considerable time researching Afrezza. They came away unimpressed with the data that’s floating around out there. quote; say they’re impressed and they’ll follow the story once it gets better insurance coverage.reply: that's the true story right there. |
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Post by cedafuntennis on Jan 9, 2019 14:16:05 GMT -5
I also spoke with 2 experienced doctors in the field who at first were very interested and once they read the available data (last year) they both said this was a niche product of almost no interest due to the warnings and low risk-reward published. Difficult to change their initial opinions so it's a total shame that they botched this to start. Mike and team are trying hard, but big ships are hard to turn and the incompetent management before them just took the money and totally failed at everything they did.
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Post by mannmade on Jan 9, 2019 14:26:15 GMT -5
I also spoke with 2 experienced doctors in the field who at first were very interested and once they read the available data (last year) they both said this was a niche product of almost no interest due to the warnings and low risk-reward published. Difficult to change their initial opinions so it's a total shame that they botched this to start. Mike and team are trying hard, but big ships are hard to turn and the incompetent management before them just took the money and totally failed at everything they did. very true. I believe this is one of the biggest if not the biggest issue with doctors. The amount of time it takes a rep or anyone to fully explain how afrezza works, why it works and what the benefits are. I had a similar experience with a doctor who fortunately is a good friend. When I first mentioned afrezza to him he also thought it was nothing more than a niche product. But because he is a good friend he listened to what I had to say and read the materials I sent him over a 3 month period. Yes it took 3 months but he finally agreed to try it on a few patients and he is now one of the leading prescribers in the country and works directly w mnkd giving talks on afrezza. Doubt many reps get this many bites at the apple w the average doc as they just seem not to have the time. |
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Post by mytakeonit on Jan 9, 2019 16:28:41 GMT -5
Sounds like doctors that find out how great Afrezza is ... don't talk to other doctors.
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Post by goyocafe on Jan 9, 2019 16:44:00 GMT -5
Sounds like doctors that find out how great Afrezza is ... don't talk to other doctors. They're probably afraid of being ostracized. |
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Post by lakers on Jan 9, 2019 19:59:54 GMT -5
An answer to cdf, mm, vdex, sayhey.
MC:
“we have over 5,000 patients in our program across 65 trials for approval and most of the posters and presentations are on the corporate mannkind site. I don’t know how a doctor can say a drug is niche after it beats the standard of care in post Prandial and showed low rates of hypo. However this is why diabetes outcomes haven’t changed in 20 years despite 40 new drugs and tripling cost of treatment in 5 years. We have a mealtime control problem across the world and this is the number 1 reason people aren’t getting to goal and I believe we will be the best solution. Day after day we are gaining new prescribers and experience. I have been hearing about VDEX for 3+ years and not sure why they haven’t been able to get a successful proof of concept up and running but I hope they do for the benefit of patients. DNASE is still there and we will look at it again and the CBD we aren’t in a position to discuss as it’s the partners decision and we are looking to bring more transparency around the focus of RLS in 2019. On saying sending doctors out is a waste of time I think that is a bold statement as we see the number 1 reason a doctor starts writing is bc of our reps and while not all are cranking the way we want we like the trends we are seeing and the new talent we have is excellent. Hang tight 2019 is our year!”
[undisclosed, consumer driven molecule could be deduced here as CBD-based, perhaps]
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Post by bundy on Jan 9, 2019 21:02:38 GMT -5
That’s a pretty great response but I just see the negative people will be saying “hang tight “ all year now  |
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Post by agedhippie on Jan 9, 2019 21:07:24 GMT -5
An answer to cdf, mm, vdex, sayhey. MC: “we have over 5,000 patients in our program across 65 trials for approval and most of the posters and presentations are on the corporate mannkind site. I don’t know how a doctor can say a drug is niche after it beats the standard of care in post Prandial and showed low rates of hypo. However this is why diabetes outcomes haven’t changed in 20 years despite 40 new drugs and tripling cost of treatment in 5 years. We have a mealtime control problem across the world and this is the number 1 reason people aren’t getting to goal and I believe we will be the best solution. ... If he doesn't understand why doctors are saying that he really ought to talk to Dr Kendall because it's obvious. Do new trials to prove the assertion or live with the pigeonhole, it's very simple. Ok - now someone is going to say it's not obvious to them The answer is that in the only significant trial to date Afrezza was non-inferior to RAA, and the hypo reduction was not statistically significant. If you want to push the fact that in absolute terms the number of hypos were down then you also have to accept that Afrezza did worse that RAA in HbA1c reduction and that looks to doctors like the reason hypos were lower was because patients ran higher with Afrezza. As for STAT-1 even it's lead investigator only described it as a pilot study. |
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Post by peppy on Jan 9, 2019 23:01:59 GMT -5
An answer to cdf, mm, vdex, sayhey. MC: “we have over 5,000 patients in our program across 65 trials for approval and most of the posters and presentations are on the corporate mannkind site. I don’t know how a doctor can say a drug is niche after it beats the standard of care in post Prandial and showed low rates of hypo. However this is why diabetes outcomes haven’t changed in 20 years despite 40 new drugs and tripling cost of treatment in 5 years. We have a mealtime control problem across the world and this is the number 1 reason people aren’t getting to goal and I believe we will be the best solution. ... If he doesn't understand why doctors are saying that he really ought to talk to Dr Kendall because it's obvious. Do new trials to prove the assertion or live with the pigeonhole, it's very simple.Ok - now someone is going to say it's not obvious to them The answer is that in the only significant trial to date Afrezza was non-inferior to RAA, and the hypo reduction was not statistically significant. If you want to push the fact that in absolute terms the number of hypos were down then you also have to accept that Afrezza did worse that RAA in HbA1c reduction and that looks to doctors like the reason hypos were lower was because patients ran higher with Afrezza. As for STAT-1 even it's lead investigator only described it as a pilot study. Aged, I happen to be reading about Adderall. Besides the mice/rat trails, the human trails were 4 week trials. 4 week children, 4 week adolescent trial, 4 week adult trial. heh. www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s026lbl.pdf6.1 Clinical Studies Experience The premarketing development program for ADDERALL XR included exposures in a total of 1315 participants in clinical trials (635 pediatric patients, 350 adolescent patients, 248 adult patients, and 82 healthy adult subjects). Of these, 635 patients (ages 6 to 12) were evaluated in two controlled clinical studies, one open-label clinical study, and two single-dose clinical pharmacology studies (N= 40). Safety data on all patients are included in the discussion that follows. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. A double-blind, randomized, multi-center, parallel-group, placebo-controlled study was conducted in adolescents aged 13-17 (N=327) who met DSM-IV® criteria for ADHD. The primary cohort of patients (n=287, weighing 75kg/165lbs) was randomized to fixed-dose treatment groups and received four weeks of treatment.
How did I end up reading about Adderall? TENUATE® a bit of a ditto, 3 week trials. I guess it didn't take long to decide to give children speed did it? |
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Post by Clement on Jan 10, 2019 9:27:18 GMT -5
I'm counting the weeks on my calendar. It appears that March 22 Symphony numbers are our first chance to see the results after that 8 weeks of advertising.
Hang in there until March 22!
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Post by slugworth008 on Jan 10, 2019 9:42:42 GMT -5
8 weeks from January 14 is merely "8 weeks from January 14" - remember - this is MNKD.
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Post by agedhippie on Jan 10, 2019 9:46:15 GMT -5
Aged, I happen to be reading about Adderall. Besides the mice/rat trails, the human trails were 4 week trials. 4 week children, 4 week adolescent trial, 4 week adult trial. heh. www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s026lbl.pdf6.1 Clinical Studies Experience The premarketing development program for ADDERALL XR included exposures in a total of 1315 participants in clinical trials (635 pediatric patients, 350 adolescent patients, 248 adult patients, and 82 healthy adult subjects). Of these, 635 patients (ages 6 to 12) were evaluated in two controlled clinical studies, one open-label clinical study, and two single-dose clinical pharmacology studies (N= 40). Safety data on all patients are included in the discussion that follows. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. A double-blind, randomized, multi-center, parallel-group, placebo-controlled study was conducted in adolescents aged 13-17 (N=327) who met DSM-IV® criteria for ADHD. The primary cohort of patients (n=287, weighing 75kg/165lbs) was randomized to fixed-dose treatment groups and received four weeks of treatment.
How did I end up reading about Adderall? TENUATE® a bit of a ditto, 3 week trials. I guess it didn't take long to decide to give children speed did it? Was that trial for Adderall, or for Adderall XR? If it was for Adderall XR they were probably just looking at the difference between standard release and extended release with all the side effects assumed to be the same. In that case four weeks might have been long enough. If it was for Adderall itself then four weeks is far to short and they should not have managed to get away with that. Edit: I should add that I agree that idea of giving kids amphetamines is not something I am personally comfortable with. |
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Post by sportsrancho on Jan 10, 2019 9:53:28 GMT -5
I'm counting the weeks on my calendar. It appears that March 22 Symphony numbers are our first chance to see the results after that 8 weeks of advertising. Hang in there until March 22! I’m holding them to this. Otherwise they need to re-think a few things. So go-get-um MNKD! |
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Post by galileo on Jan 10, 2019 11:53:00 GMT -5
An answer to cdf, mm, vdex, sayhey. MC: “we have over 5,000 patients in our program across 65 trials for approval and most of the posters and presentations are on the corporate mannkind site. I don’t know how a doctor can say a drug is niche after it beats the standard of care in post Prandial and showed low rates of hypo. However this is why diabetes outcomes haven’t changed in 20 years despite 40 new drugs and tripling cost of treatment in 5 years. We have a mealtime control problem across the world and this is the number 1 reason people aren’t getting to goal and I believe we will be the best solution. Day after day we are gaining new prescribers and experience. I have been hearing about VDEX for 3+ years and not sure why they haven’t been able to get a successful proof of concept up and running but I hope they do for the benefit of patients. DNASE is still there and we will look at it again and the CBD we aren’t in a position to discuss as it’s the partners decision and we are looking to bring more transparency around the focus of RLS in 2019. On saying sending doctors out is a waste of time I think that is a bold statement as we see the number 1 reason a doctor starts writing is bc of our reps and while not all are cranking the way we want we like the trends we are seeing and the new talent we have is excellent. Hang tight 2019 is our year!” [undisclosed, consumer driven molecule could be deduced here as CBD-based, perhaps] Not sure where Lakers got this quote from MC but if true, it displays a shocking level of ignorance. I don’t know how a doctor can say a drug is niche after it beats the standard of care in post Prandial and showed low rates of hypo. This guy is the CEO? Really!? Does he not know that most of the published info about Afrezza is unimpressive? Does he not know that doctors will not research or accept MNKD's anecdotal data? Does he not know that the standard of care is well established and does not include a product like Afrezza until very late in the disease progression? No wonder the company is failing. I've noticed another fatal quality in MC: he never admits weakness or failure. He hasn't learned that honesty even when it cuts against us is a strength. MC's always confident publicly. I remember a quote from Warren Buffett about this type of behavior. He said the problem with the executive who lies to the public is that he eventually lies to himself in private. MC has been spinning the company's 2018 results as something other than what they are which is unadulterated failure. Why should we expect anything different in 2019? BOD wake up! |
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