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Post by sweedee79 on Dec 2, 2015 21:00:47 GMT -5
That Biotech guy is really irritating... is there actually an ignore feature here?? I'm new to this board... but I would really like one right now.... Seems this guy is looking for things he can complain about none of which are based on anything real..That begs me to question why he is here. Anyway, I know and have talked to quite a few people who have diabetes and not one of them has brought up the fear of inhaling Afrezza .. they inject something that is much less natural into their systems every time they use Novolog or Humolog which then causes them to gain weight and feel lethargic..they are also forced to watch strictly evey single thing they eat ... etc .
. Regarding the number of scripts.. how can anyone expect that sales would be out of the park when Afrezza hasn't even been advertised yet.. Clearly a very slow and methodical launch is going on.. which IMO is smart tho perhaps frustrating as we watch the stock price manipulated down and the company running out of funds... however, Afrezza is the real deal ...
To get back on topic.this meeting is an important event .. and IMO from what I have gathered a large educational campaign is about to begin followed by another large DTC campaign...Someone on YMB speculated that perhaps Dr. Steven Edelman of UCSD would be there.. if we can get the knowledge out there the label will be less restrictive.. we will then have more time to complete clinical studies to in fact get that label changed some time in the future.. there is definitely something going on... |
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Post by bill on Dec 2, 2015 21:01:07 GMT -5
Ah, biotec this is getting tedious, but I'll indulge you once again even though your writing style reminds me of several YMB MNKD bashers. Let's start with "common sense." Common sense would say that Afrezza isn't as damaging to the lungs as a cigarette based on the MNKD study that examined lung tissue of early participants after they'd been using Afrezza for several years. They found no damage whatsoever, not to mention the study that showed that 90+% of the TS particles were excreted, i.e., not left lining the lungs. Finally, note that users will probably inhale Afrezza cartridges between 3 and 5 times a day, on average--one puff per cartridge. A single cigarette gets consumed with about 10 puffs. Therefore, even if Afrezza were as dangerous to the lungs as a cigarette it would be no worse than smoking one cigarette every other day. That comes to less than a pack per month in cigarette consumption. Now let's move on to the Black box warning and lung spirometry. The warning and the spirometer test are there to warn physicians not to prescribe Afrezza to PWDs who's lungs are already compromised because of the increased risk of bronchospasms. It's totally irrelevant for anyone without lung problems which is the category of patients that will be using Afrezza. Not once did I say Afrezza was the same as smoking! I said uneducated people might and will think that! And that's why I think the low acceptance with doctors and patient is do the the fact it might hurt there lungs. Why do you thing the low acceptance? Your original statement was: "The biggest setback I think is that its inhaled via the lung." I asked you for evidence backing your claim and you provided the smoking analogy. You made a common sense association between Afrezza and smoking in an attempt to justify your claim. Bottom line, is that a reasonable person can only conclude that you have no facts or data to substantiate that claim. End of that discussion. I demonstrated that common sense didn't back your argument or your analogy. Finally, you asked what I thought about the "low acceptance." Not so clever choice of words. Once again, I don't believe you have any data that would back a claim of "low acceptance." Data suggests just the opposite. Low acceptance is quite a bit different than low prescriptions. I'm going to ignore the low acceptance bait you threw out, and respond to my thoughts on low scripts. My personal opinion about the low scripts, backed by some facts and anecdotes are that price (higher than injectable prandial insulins), insurance coverage (less comprehensive than that for injectable prandial insulins), and lack of awareness (based on many subjective data points that indicate most endos, physicians, and PWDs are unaware of Afrezza's existence) are the primary reasons for low scripts. |
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Post by liane on Dec 2, 2015 21:04:40 GMT -5
sweedee79, Click on their user name. From their profile that comes up, click on the gear icon in the upper right. Then - Block member.
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Post by mssciguy on Dec 2, 2015 21:05:15 GMT -5
The biggest setback I think is that its inhaled via the lung. So many out there think its the same as smoking cigarettes. Non educated diabetics are going to think like this. Via Lung= danger Dude--- I have taken graduate courses in atmospheric science. Particulates like those in Afrezza are a part of everyday life, even if (or maybe especially if) you live on your couch watching TV... Please, yeah we all have an IQ over 100 here, some or mostly much higher than that, don't talk down to us. If you would like to start a thread titled "Dudes, I know FDA and Martin Shrekeli all thought about these things millions of times until they were disproven by MNKD at a cost of 2 years and a billion dollars" well go right ahead but your posts have absolutely no place here, completely out of context for the current topic. Please. |
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Post by rockstarrick on Dec 2, 2015 21:09:22 GMT -5
The biggest setback I think is that its inhaled via the lung. So many out there think its the same as smoking cigarettes. Non educated diabetics are going to think like this. Via Lung= danger Inhaled via the lungs is one of the greatest advantages of afrezza. !! Where else would you inhale it to ?? This was the plan from day 1, "Inhaled Insulin". NO NEEDLES !! Carbon coated "human insulin" Diabetics inhaling Carbon, the 6th most abundant element on Earth + human insulin for almost a full year, with literally no adverse health affects SO FAR, actually, there have been documented health benefits. Normal liver function tests, Retinopathy reversed, Insulin resistance reversed, Charles Lacy reports no more asthma after starting afrezza off label due to having asthma. I don't know where you have been getting your information from, but what you are commenting about has never been an issue. Can you provide a source to prove people are discontinuing afrezza ?? Your question why so many samples but not many scripts will soon be answered IMO. Good Luck to all |
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Post by rockstarrick on Dec 2, 2015 21:11:23 GMT -5
The biggest setback I think is that its inhaled via the lung. So many out there think its the same as smoking cigarettes. Non educated diabetics are going to think like this. Via Lung= danger Dude--- I have taken graduate courses in atmospheric science. Particulates like those in Afrezza are a part of everyday life, even if (or maybe especially if) you live on your couch watching TV... Please, yeah we all have an IQ over 100 here, some or mostly much higher than that, don't talk down to us. If you would like to start a thread titled "Dudes, I know FDA and Martin Shrekeli all thought about these things millions of times until they were disproven by MNKD at a cost of 2 years and a billion dollars" well go right ahead but your posts have absolutely no place here, completely out of context for the current topic. Please. Bump |
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Post by ezrasfund on Dec 2, 2015 21:11:50 GMT -5
The biggest setback I think is that its inhaled via the lung. So many out there think its the same as smoking cigarettes. Non educated diabetics are going to think like this. Via Lung= danger Dude--- I have taken graduate courses in atmospheric science. Particulates like those in Afrezza are a part of everyday life, even if (or maybe especially if) you live on your couch watching TV... Please, yeah we all have an IQ over 100 here, some or mostly much higher than that, don't talk down to us. If you would like to start a thread titled "Dudes, I know FDA and Martin Shrekeli all thought about these things millions of times until they were disproven by MNKD at a cost of 2 years and a billion dollars" well go right ahead but your posts have absolutely no place here, completely out of context for the current topic. Please. The point is you are both right. Breathing insulin is associated with fear of cancer...erroneously. |
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Post by dreamboatcruise on Dec 2, 2015 21:18:46 GMT -5
I don't agree with biotec that the unfounded cancer scare is likely the biggest roadblock, but I'm sure it plays a role. It certainly got raised as an issue with Exubera. If everyone in the medical community believed there was no possibility of a risk, MNKD would not have spent the significant resources on doing those trials specifically to prove it isn't a problem. Like it or not, the FDA has specified long term safety studies... those that are ultra cautious may well think it safest to wait until those are done. biotec may simply have a different risk profile than others here and thus, even if not believing this specific unfounded risk, believe the concern occurs more in others than we do. Personally, here is how I imagine it might be most harming Afrezza. You've got some overworked doc. He's heard about Afrezza but just to the extent it's non-inferior and doesn't require needle. He vaguely remembers something about safety concerns with Exubera... perhaps even mistakenly thinking that the concerns had to do with its withdrawal from the market. Says to himself... eh, doesn't seem compelling if it's just a patient convenience thing, maybe I'll wait for more safety data. |
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Post by bill on Dec 2, 2015 21:20:07 GMT -5
Dude--- I have taken graduate courses in atmospheric science. Particulates like those in Afrezza are a part of everyday life, even if (or maybe especially if) you live on your couch watching TV... Please, yeah we all have an IQ over 100 here, some or mostly much higher than that, don't talk down to us. If you would like to start a thread titled "Dudes, I know FDA and Martin Shrekeli all thought about these things millions of times until they were disproven by MNKD at a cost of 2 years and a billion dollars" well go right ahead but your posts have absolutely no place here, completely out of context for the current topic. Please. The point is you are both right. Breathing insulin is associated with fear of cancer...erroneously. No ezrasfund, they aren't both right. biotec said lung inhalation was the biggest reason not a reason. There's no data that suggests fear of breathing Afrezza is the primary reason for low scripts. It may be a reason why some PWDs are not looking at Afrezza and reasonable people could try to estimate that, but it's certainly not at the top of the list for the low script. |
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Post by ezrasfund on Dec 2, 2015 21:31:48 GMT -5
Biggest reason or just a reason...? You might want to read this article by Nassim Taleb "The Most Intolerant Wins; The Dominance of the Stubborn Minority" which explores the effect of small but persistent effects on complex systems. In truth there is really no way to rank by importance the obstacles that Afrezza needs to overcome. But in complex systems (like determining medical protocols) size and persistence are only two of the often asymmetrical variables. dl.dropboxusercontent.com/u/50282823/minority.pdfWorth a read anyway from one of the most important philosophers of our time. |
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Post by suebeeee1 on Dec 2, 2015 22:30:13 GMT -5
As I have been told the meeting is a practitioner's advisory board. This will likely involve the input of a small group of practitioners to discuss whatever topics the company wishes to discuss. What is to be discussed is not known by me. A speaker's training meeting would involve a larger number of practitioners being trained to lead presentations either locally, regionally, or nationally regarding Afrezza. This meeting is not a speaker's training meeting. I have no more information or specifics than this. It sounds to me like maybe a last ditch effort to find out why Afrezza works for some and not others. Maybe why so many samples went out and no refills on those samples, And why with all the trials only a little fraction on participants are using Afrezza? Many see this as a good thing, I myself see's it as a corrective action meeting. I was thinking at first this was an advertisement audition meeting. Maybe after getting a sample, they find out their insurance company will not cover it. |
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Post by compound26 on Dec 2, 2015 22:41:15 GMT -5
It sounds to me like maybe a last ditch effort to find out why Afrezza works for some and not others. Maybe why so many samples went out and no refills on those samples, And why with all the trials only a little fraction on participants are using Afrezza? Many see this as a good thing, I myself see's it as a corrective action meeting. I was thinking at first this was an advertisement audition meeting. Maybe after getting a sample, they find out their insurance company will not cover it. I think since Afrezza's awareness is minimal, a lot of times doctors gave the samples to existing Afrezza users, rather than to someone who has never tried afrezza. In those circumstances, samples do not necessarily lead to new users. See examples below. Also see examples here: Afrezza SouvenierAnd for people who tried Afrezza and loved Afrezza, but have to gave up Afrezza for cost or other reasons, see posts below: I tried Afrezza- but I don't use it now. Also see this message: |
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Post by sluggobear on Dec 2, 2015 22:46:37 GMT -5
I don't agree with biotec that the unfounded cancer scare is likely the biggest roadblock, but I'm sure it plays a role. It certainly got raised as an issue with Exubera. If everyone in the medical community believed there was no possibility of a risk, MNKD would not have spent the significant resources on doing those trials specifically to prove it isn't a problem. Like it or not, the FDA has specified long term safety studies... those that are ultra cautious may well think it safest to wait until those are done. biotec may simply have a different risk profile than others here and thus, even if not believing this specific unfounded risk, believe the concern occurs more in others than we do. Personally, here is how I imagine it might be most harming Afrezza. You've got some overworked doc. He's heard about Afrezza but just to the extent it's non-inferior and doesn't require needle. He vaguely remembers something about safety concerns with Exubera... perhaps even mistakenly thinking that the concerns had to do with its withdrawal from the market. Says to himself... eh, doesn't seem compelling if it's just a patient convenience thing, maybe I'll wait for more safety data. Some more rabid "speculation" which is another word I hate now - almost as much as "hope"! The long term patient lung safety studies were baked in to the Sanofi-Mannkind partnership and might be considered an instrumental part in the future strategic planning for Afrezza. Sanofi knew it would have responsibility for the 5 yr, 8000+ patient lung safety studies (the most daunting PMR from the FDA) when it partnered with Mannkind. www.accessdata.fda.gov/scripts/cder/pmc/index.cfmThe first 2 Afrezza PMR studies (of 4) are complete and Sanofi is recruiting for the 3rd PMR (pediatric safety study). In addition to the results from the strictly controlled euglycemic clamp and PK/PD clinical studies, they need to understand absolute and temporal dosing requirements in real life use. They need to glean as much information as possible to understand the barriers to Rx. The best strategic minds had BETTER be at work in Sanofi's Clinical & Regulatory departments. I have to assume that Sanofi's Marketing, Clinical/Regulatory groups are: 1) following the experiences of more public early Afrezza adopters and Afrezza users in general, and MEETING with them in person to discuss. 2) laying out clinical protocol approaches to satisfy the lung safety PMR and incorporate the collection of 1-2 year superiority data on Afrezza. 3) holding advisory board meetings with opinion leader MD's, PhD researchers, and other experts to present early adopter results and to get feedback for the lung safety clinical trial protocols and other smaller cohort studies. It sure seems to me that Sanofi is not giving up on Afrezza. |
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Post by kball on Dec 2, 2015 23:31:44 GMT -5
Maybe after getting a sample, they find out their insurance company will not cover it. I think since Afrezza's awareness is minimal, a lot of times doctors gave the samples to existing Afrezza users, rather than to someone who has never tried afrezza. In those circumstances, samples do not necessarily lead to new users. See examples below. Also see examples here: Afrezza SouvenierAnd for people who tried Afrezza and loved Afrezza, but have to gave up Afrezza for cost or other reasons, see posts below: I tried Afrezza- but I don't use it now. Also see this message:
Sweedee is posting here now too |
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Post by cathode on Dec 2, 2015 23:48:44 GMT -5
The biggest setback I think is that its inhaled via the lung. So many out there think its the same as smoking cigarettes. Non educated diabetics are going to think like this. Via Lung= danger Inhaled via the lungs is one of the greatest advantages of afrezza. !! Where else would you inhale it to ?? This was the plan from day 1, "Inhaled Insulin". NO NEEDLES !! Carbon coated "human insulin"
Diabetics inhaling Carbon, the 6th most abundant element on Earth + human insulin for almost a full year, with literally no adverse health affects SO FAR, actually, there have been documented health benefits. Normal liver function tests, Retinopathy reversed, Insulin resistance reversed, Charles Lacy reports no more asthma after starting afrezza off label due to having asthma. I don't know where you have been getting your information from, but what you are commenting about has never been an issue. Can you provide a source to prove people are discontinuing afrezza ?? Your question why so many samples but not many scripts will soon be answered IMO. Good Luck to all This is not correct, or way oversimplified, or something.... misinformed.... I will stick with not correct.... Afrezza is definitely not "carbon coated" insulin. And the abundance of carbon on Earths surface (C is definitely not that common in the solid Earth) has nothing to do with its safety to humans. This is really just a misinformed post. One star out of five. |
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