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Post by matt on Aug 6, 2019 9:58:21 GMT -5
So in summary, it's: 1. There is not enough compelling data right now to support use of Afrezza vs other RAAs 2. The risk hasn't proven to outweigh the benefit 3. The cost hasn't proven to outweigh the burden 4. Even if 1, 2, and 3 are proven, the vast majority of people would either still not have access to or be able to afford Afrezza How to fix: 1. Fund an expensive well-designed clinical trial to prove superiority as well as small number needed to treat for cost burden purposes 2. Wait several years for the cream to rise to the top and for all the data to eventually find its way (assuming favorable results with Afrezza usage) I was with your logic all the way until your last point. I don't think you can be passive and assume the data will find its way to the desired audience. Remember the first rule of war; the enemy gets a vote too. The competition will make lots of noise and attempt to preserve their market share, as well they should, so it is foolish to assume that mere existence of the data is all it will take. The rest I agree with. I read a lot of medical journals, every single week, and I have a good sense about the quality of research needed to make a meaningful impact on the medical profession. What MNKD has produced to date is not sufficiently persuasive to change the minds of most clinicians. Shareholders like to talk about the 60-odd studies that Dr. Kendall likes to talk about, but changing medical practice is not about the quantity of studies but it is all about the quality. Large studies mean really large, and for a metabolic disease like diabetes that means several thousand subjects per cohort. Why so many? Because diabetes contributes to so many other comorbid conditions that you need a large population to be able to sort out what was the treatment effect of the drug and which observations were caused by the underlying disease, and in hypothesis testing statistics larger sample sizes are your friend. Until there is better data the label is going to read " Afrezza provided less HbA1c reduction than insulin aspart, and the difference was statistically significant." Honestly, can you blame a physician for not prescribing Afrezza after reading that? The other mistake that was made when bringing Afrezza to market was the failure to do an economic study at the same time the company did the clinical study. Had MNKD started to collect economic data back when the drug was being trialed, they might have some hard data by now and perhaps, just perhaps, an economic argument sufficient to improve reimbursement. It will take even longer to demonstrate the cost benefits of the drug than the therapeutic benefits, but that data will always be 5-10 years away until the company starts a proper study. Every year that goes by without starting such a study is another year before the company can start to drive sales effectively. Likewise, don't assume that the study to prove the economic benefits is "a small number" because the same confounding factors that apply to the therapeutic study will apply to the economic study. The economics need to be part of the clinical study regardless of how many patients that will take. The question, as always, is can the company even think about funding the required studies?
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WTF
Aug 6, 2019 11:46:20 GMT -5
Post by ktim on Aug 6, 2019 11:46:20 GMT -5
Has everyone forgot about the Black Box warning. It would seem that Kendall and all of the MNKD studies he touts could get that changed.What efforts are being made? Dr.s see that as an easy excuse not to prescribe for whatever their real reason may be. Perhaps they are really concerned about a potential suit brought by a patient. Perhaps they just don't want to change their treatment to one with a Black Box warning. If I were a person PWD I would insist that my doc prescribe Afrezza or I would find a new endo and tell them why I was changing. After all they are working for me. I pay the insurance for the office visit and the drugs. I would say screw the Black Box warning I want Afrezza as my treatment. I think too many PWDs are willing to take take no for an answer. Whatever the doctor's reason for resisting a prescription the final decision/responsibility is with the patient who wants it. Doctors aren't gods, though many think they are. (Present PB members excluded) What studies have shown that broncospasm isn't a problem for those with asthma or COPD? If you don't have the contraindications there is no need to say "screw the black box" but rather simply "it doesn't apply to me". If a patient does have the contraindications then it is judgement of patient and doc as to risk/reward of ignoring black box.
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WTF
Aug 6, 2019 11:47:45 GMT -5
Post by radgray68 on Aug 6, 2019 11:47:45 GMT -5
I don't believe perks have dried up. They just went underground. A deep dive into the financed of the doctors would be required to prove it. Nobody has the stomach for that. Hence, the cycle continues. Pharmas still pay some docs to give talks and to serve on advisory boards. All that info is readily available. But that is relatively small number of "influential" docs. I've talked to sales reps when the crackdowns started occurring that complained about having to faze out dinners, rounds of golf and gifts as a sales technique, so I tend to believe that has actually changed. Do you personally know of sales reps that routinely give gifts/kickbacks or doctors that accept them, or are you just cynically believing it has to be the case? The Sunshine Act came out around 10 years ago. It was supposed to illuminate the relationship between manufacturers and healthcare providers? Suddenly, we have huge PBMs as a buffer between them. You think this is a coincidence? Now manufacturers have plausible deniability. "Oh, we had no idea what was going on." Cynical? Yes. Incorrect in my assumptions? Well, I am a capitalist. I believe if there's a will, there's a way. Pharmaceutical profits are at new highs from 10 years ago.
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WTF
Aug 6, 2019 11:56:00 GMT -5
Post by ktim on Aug 6, 2019 11:56:00 GMT -5
Pharmas still pay some docs to give talks and to serve on advisory boards. All that info is readily available. But that is relatively small number of "influential" docs. I've talked to sales reps when the crackdowns started occurring that complained about having to faze out dinners, rounds of golf and gifts as a sales technique, so I tend to believe that has actually changed. Do you personally know of sales reps that routinely give gifts/kickbacks or doctors that accept them, or are you just cynically believing it has to be the case? The Sunshine Act came out around 10 years ago. It was supposed to illuminate the relationship between manufacturers and healthcare providers? Suddenly, we have huge PBMs as a buffer between them. You think this is a coincidence? Now manufacturers have plausible deniability. "Oh, we had no idea what was going on." Cynical? Yes. Incorrect in my assumptions? Well, I am a capitalist. I believe if there's a will, there's a way. Pharmaceutical profits are at new highs from 10 years ago. So now your asserting that PBMs are giving gifts/kickbacks to physicians? Not that PBMs aren't a problem in our medical system, but no I don't buy that at all. The mechanism that PBMs use to enforce prescribing of certain drugs is the tier system and onerous prior authorization process... no need to use "carrot" of gifts and kickbacks.
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WTF
Aug 6, 2019 12:20:21 GMT -5
Post by radgray68 on Aug 6, 2019 12:20:21 GMT -5
The Sunshine Act came out around 10 years ago. It was supposed to illuminate the relationship between manufacturers and healthcare providers? Suddenly, we have huge PBMs as a buffer between them. You think this is a coincidence? Now manufacturers have plausible deniability. "Oh, we had no idea what was going on." Cynical? Yes. Incorrect in my assumptions? Well, I am a capitalist. I believe if there's a will, there's a way. Pharmaceutical profits are at new highs from 10 years ago. So now your asserting that PBMs are giving gifts/kickbacks to physicians? Not that PBMs aren't a problem in our medical system, but no I don't buy that at all. The mechanism that PBMs use to enforce prescribing of certain drugs is the tier system and onerous prior authorization process... no need to use "carrot" of gifts and kickbacks. You said it. I believe there are two ways to motivate a horse. The carrot and the stick. Some horses just need a carrot, some need a PA, er......a tier......I mean a stick. 😉
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Post by mytakeonit on Aug 6, 2019 13:00:31 GMT -5
Quarterly and CC is tomorrow. Stay tuned folks !!!
But, that's mytakeonit
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Post by sweedee79 on Aug 6, 2019 13:04:02 GMT -5
It's too quiet today!!!!!
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WTF
Aug 6, 2019 13:07:25 GMT -5
Post by awesomo on Aug 6, 2019 13:07:25 GMT -5
Quarterly and CC is tomorrow. Stay tuned folks !!! But, that's mytakeonit What do you think will come out of the earnings call?
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Post by akemp3000 on Aug 6, 2019 14:03:13 GMT -5
It will be the first time we hear actual revenue following the new script programs that were introduced. This may or may not have significance. We should hear more detail about the One Drop and Bluhale plans. We should hear an update on Brazil and other international progress. It would definitely be interesting to hear about UTHR's next molecule or RLS plans though I don't expect that to happen tomorrow. The best perspective is to expect nothing new and hopefully be pleasantly surprised. GLTA
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WTF
Aug 6, 2019 14:45:00 GMT -5
Post by mytakeonit on Aug 6, 2019 14:45:00 GMT -5
I expect Mike C will say that he will meet me in Las Vegas and discuss buying a home in Hawaii. BTW, the home across the street from me will be going up for sale soon!
But, that's mytakeonit
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Post by sportsrancho on Aug 6, 2019 16:14:08 GMT -5
Quarterly and CC is tomorrow. Stay tuned folks !!! But, that's mytakeonit What do you think will come out of the earnings call? Well something good better come out of it because he’s been pushing this cc for weeks!!
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Post by cretin11 on Aug 6, 2019 16:41:34 GMT -5
My prediction is that after tomorrow, the new mytakeonit mantra will be "stay tuned for the CC in November!"
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Post by awesomo on Aug 6, 2019 16:43:56 GMT -5
What do you think will come out of the earnings call? Well something good better come out of it because he’s been pushing this cc for weeks!! We've never gotten anything like that before from a CC so I wouldn't hold my breath.
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Post by akemp3000 on Aug 6, 2019 16:53:48 GMT -5
I expect Mike C will say that he will meet me in Las Vegas and discuss buying a home in Hawaii. BTW, the home across the street from me will be going up for sale soon! But, that's mytakeonit WTF
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Post by letitride on Aug 6, 2019 17:38:02 GMT -5
I expect Mike C will say we all have reason to meet in Las Vegas and buy homes in Hawaii. Great Expectations or flash back may the conference call be the judge of this.
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