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Post by centralcoastinvestor on Jul 30, 2017 10:24:39 GMT -5
Tinkerbell, great post. After reading your post (I didn't quote you because the post is getting too long), something came to mind about why I like this white paper from VDex. It's written so that I can understand it. I am just an average person that can understand some of the scientific studies written about Afrezza. But most of the time, I don't understand the fancy wording in scientific journals. This white paper was written for the rest of us "commoners" in a language we can understand. That is why it will help a lot of diabetics understand how Afrezza really works. Yes, FDA quality scientific studies are absolutely necessary, but sometimes someone needs to explain in average language how something really works in everyday life.
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Tinkerbell
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Post by Tinkerbell on Jul 30, 2017 10:31:27 GMT -5
Tinkerbell, great post. After reading your post (I didn't quote you because the post is getting too long), something came to mind about why I like this white paper from VDex. It's written so that I can understand it. I am just an average person that can understand some of the scientific studies written about Afrezza. But most of the time, I don't understand the fancy wording in scientific journals. This white paper was written for the rest of us "commoners" in a language we can understand. That is why it will help a lot of diabetics understand how Afrezza really works. Yes, FDA quality scientific studies are absolutely necessary, but sometimes someone needs to explain in average language how something really works in everyday life. You just drove the proverbial nail in the coffin of naysayers! Thanks for that. |
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Post by sportsrancho on Jul 30, 2017 10:33:56 GMT -5
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Post by peppy on Jul 30, 2017 10:41:07 GMT -5
oh, thank you tinkerbell, you took the time.
I am excited that the Vdex medical staff, decided to learn afrezza inside out as far as hypoglycemic risk, that they initiated this in house, observational study.
This is the type of physician team I would want if I had diabetes. This is what physicians do, after a medication comes out and they put their people on it, they follow their peoples progress. Vdex staff wanted to know exactly the risk and did an in house test.
Also dosage instruction.
It looks like a fine team to me.
I remember when surfactant came into neonatal medicine, it stopped the chronic lung. The physicians could see it. the blood gasses improved, the babies weaned from the vent.
What I am saying, is sometimes medical staff get to see the amazing change that can happen when a helpful new medication is introduced.
weehaw.
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Post by brotherm1 on Jul 30, 2017 11:10:56 GMT -5
Tinkerbell, while reading your post I thought I heard the ballad America playing in the background. Yes, it is written in a layperson's language and serves - as you say - as a beacon to such readers. It is because of that that I had no qualms passing it onto a few friends and will be passing it onto others this week.
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Tinkerbell
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Post by Tinkerbell on Jul 30, 2017 11:36:02 GMT -5
Tinkerbell, while reading your post I thought I heard the ballad America playing in the background. Yes, it is written in a layperson's language and serves - as you say - as a beacon to such readers. It is because of that that I had no qualms passing it onto a few friends and will be passing it onto others this week. Wonderful. It's not such a bad idea to share (with the right caveats of course) this little David's slingshot and stone despite Goliath's height, girth and influence. In fact despite its crude and innocuous appearance, it may come to bear on 'the many' in ways that others before them simply could not conceive of. The challenge has been made and the request for a paradigm shift has been echoed to all laypersons. So now it's up to the medical establishment to determine if they need to step up to the plate and further weaken the white paper (as some will choose to do) or in fact add to its merit. The 4 week study is underway comparing Technosphere Insulin to Lispro through an investigator initiated trial. Those results will come soon enough nevertheless, between now and then, this ball has been lobbed squarely into the court of any and all naysayers - layman or not. Like I said, it's time to get cracking or, shut up and watch your patients move over to VDEX. The choice will become very apparent and sooner than many think. |
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Post by Deleted on Jul 30, 2017 11:38:53 GMT -5
This paper was done for money guys not for doctors and especially not for research types. The 3 figures were presented for illustrative purposes. VDex has no intention of explaining to the money guys how a 2 strand amino acid with a molecular weight of 5808 Da is different and acts different than an analog weighing 5825.8 Da. Done for money guys? Where do you get that from? The introduction says the studies were soley for internal use. The line "Vdex has chosen to release this White Paper publicly due to the need for better therapies to control the exploding disease of diabetes", if anything, suggests to me that it was released for the benefit of the medical community. If you have additional information, please do share. Frankly, if the paper WAS done and released for 'money guys' then IMHO the paper becomes promotional garbage and the medical community will treat it as such. So I hope it was not. From google when the term white paper is searched: A white paper is an informational document issued by a company to promote or highlight the features of a solution, product or service. White papers are sales and marketing documents used to entice or persuade potential customers to learn more about or purchase a particular product, service, technology or methodology. Get the incinerator started. |
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Post by cyn on Jul 30, 2017 11:51:51 GMT -5
oldfish, While your points are indeed well made, imo, Vdex's "white paper" satisfactorily achieves the intended purpose to supplement/increase understanding of a highly complex issue and will help promote Afrezza awareness/visibility across all marketing levels. Moreover, this white paper directly and successfully supports "The Goal of Vdex...We at Vdex believe with the latest therapies and technological innovations, our patients can SAFELY maintain average HbA1c levels significantly below 6.5 and even 6.0. A significant number of patients using Vdex protocols actually have HbA1c levels BELOW 6.0, all with NO INCREASE IN HYPOGLYCEMIA." www.vdexdiabetes.com/
MNKD must give immediate wide-distribution of this document and include a link on their website.
en.wikipedia.org/wiki/White_paper
"In business-to-business marketing[edit]
Since the early 1990s, the term "white paper" has been applied to documents used as marketing or sales tools in business. These white papers are long-form content designed to promote the products or services from a specific company. As a marketing tool, these papers use selected facts and logical arguments to build a case favorable to the company sponsoring the document. B2B white papers are often used to generate sales leads, establish thought leadership, make a business case, or inform and persuade prospective customers, channel partners, journalists, analysts, or investors.
White papers are considered to be as a form of content marketing or inbound marketing; in other words, sponsored content available on the web with or without registration, intended to raise the visibility of the sponsor in search engine results and thus build web traffic. Many B2B white papers argue that one particular technology, product or method is superior for solving a specific business problem. They may also present research findings, list a set of questions or tips about a certain business issue, or highlight a particular product or service from a vendor.[10]
There are, essentially, three main types of commercial white papers:
Backgrounder: Describes the technical or business benefits of a certain vendor's offering, either a product, service, or methodology. This type of white paper is best used to supplement a product launch, argue a business case, or support a technical evaluation at the bottom of the sales funnel.
Numbered list: Presents a set of tips, questions, or points about a certain business issue. This type is best used to get attention with new or provocative views, or cast aspersions on competitors, especially by using FUD.
Problem/solution: Recommends a new, improved solution to a nagging business problem. This type is best used to generate leads at the top of the sales funnel, build mind share, or inform and persuade stakeholders.[11]
While a numbered list may be combined with either other type, it is not workable to combine the detailed product information of a backgrounder with the industry-wide perspective of a problem/solution white paper."
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Tinkerbell
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Post by Tinkerbell on Jul 30, 2017 12:13:56 GMT -5
Done for money guys? Where do you get that from? The introduction says the studies were soley for internal use. The line "Vdex has chosen to release this White Paper publicly due to the need for better therapies to control the exploding disease of diabetes", if anything, suggests to me that it was released for the benefit of the medical community. If you have additional information, please do share. Frankly, if the paper WAS done and released for 'money guys' then IMHO the paper becomes promotional garbage and the medical community will treat it as such. So I hope it was not. From google when the term white paper is searched: A white paper is an informational document issued by a company to promote or highlight the features of a solution, product or service. White papers are sales and marketing documents used to entice or persuade potential customers to learn more about or purchase a particular product, service, technology or methodology. Get the incinerator started. Indeed. It's high time we smelled the stench of burning white coats and less oft used stethescopes. Any MD in the US could have done what VDEX did in perhaps a better written paper with additional clarity AND without the need for an IRB approval. Such white paper would have had the same aim - attract patients to their practice. Last I checked, there is NO LAW against doing fine work outside of a clinical trial to push science beyond the traditional sponsor/investigator funded trials. None. So I repeat, white coats to the fire. |
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Post by sophie on Jul 30, 2017 12:32:54 GMT -5
Indeed. It's high time we smelled the stench of burning white coats and less oft used stethescopes. Any MD in the US could have done what VDEX did in perhaps a better written paper with additional clarity AND without the need for an IRB approval. Such white paper would have had the same aim - attract patients to their practice. Last I checked, there is NO LAW against doing fine work outside of a clinical trial to push science beyond the traditional sponsor/investigator funded trials. None. So I repeat, white coats to the fire. The problem isn't the white coats. You don't want your doctor following white papers. You want your doctor to follow tried and true, peer-reviewed and meta-analysis papers. The problem is that MNKD needs to get the FDA on board with all of these claims. I have a cousin who is a diabetic NP and she is watching and waiting for Afrezza to be safe before she prescribes. I asked her how long she needs to wait before she feels safe- her answer- once there is a long-term safety study that signs off on it. You can find all sorts of doctors out there- What separates them from the witch doctors in Africa is their conservative approach to proven medicine. For better or for worse, I'm sure you would prefer a Western doctor to an African witch doctor. As has been said on here many times, the first oath a physician takes is to first do no harm. Whether you want to argue that prolonging Afrezza is doing harm is your prerogative. However, in the face of effective treatment, doing no harm means to make sure it is safe before prescribing. That weight falls on MNKD and MNKD alone. |
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Post by peppy on Jul 30, 2017 12:36:41 GMT -5
Indeed. It's high time we smelled the stench of burning white coats and less oft used stethescopes. Any MD in the US could have done what VDEX did in perhaps a better written paper with additional clarity AND without the need for an IRB approval. Such white paper would have had the same aim - attract patients to their practice. Last I checked, there is NO LAW against doing fine work outside of a clinical trial to push science beyond the traditional sponsor/investigator funded trials. None. So I repeat, white coats to the fire. The problem isn't the white coats. You don't want your doctor following white papers. You want your doctor to follow tried and true, peer-reviewed and meta-analysis papers.
The problem is that MNKD needs to get the FDA on board with all of these claims. I have a cousin who is a diabetic NP and she is watching and waiting for Afrezza to be safe before she prescribes. I asked her how long she needs to wait before she feels safe- her answer- once there is a long-term safety study that signs off on it. You can find all sorts of doctors out there- What separates them from the witch doctors in Africa is their conservative approach to proven medicine. For better or for worse, I'm sure you would prefer a Western doctor to an African witch doctor. As has been said on here many times, the first oath a physician takes is to first do no harm. Whether you want to argue that prolonging Afrezza is doing harm is your prerogative. However, in the face of effective treatment, doing no harm means to make sure it is safe before prescribing. That weight falls on MNKD and MNKD alone. quote: You don't want your doctor following white papers. You want your doctor to follow tried and true, peer-reviewed and meta-analysis papers
reply: I disagree. I want my doctor to follow his own eyeballs. I want my doctor listening. It is the actual clinical response physicians need the freedom to listen to. The physicians are the fed back mechanisms. Hello.
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Post by wgreystone on Jul 30, 2017 12:56:01 GMT -5
A Final Word... We shouldn’t be surprised that this product is the outgrowth of Alfred Mann’s genius. He was innovative, brilliant, and more than a touch stubborn, qualities of all successful entrepreneurs. He counseled, “take care of the patient and the business will take care of itself.” For him, success was a byproduct of delivering value to others. He brought the world the insulin pump for Type I diabetic patients, understanding the need for a better solution to the multiple daily injections that preceded the pump. Decades ago Al saw the ravages of Type 2 diabetes as well. He felt compelled to turn his prodigious talents toward finding a solution. He saw the development of many treatments and the glaring deficiency that remained: a truly physiologic prandial insulin. The pharmaceutical industry saw the problems with insulin and developed a myriad of drugs to circumvent the use of insulin. Al Mann saw the problems with insulins and said, “We need to develop a better insulin.” Of course he did. And, he gave us Afrezza. To all medical providers in diabetes: you should heed Al Mann’s advice, “take care of patients...” In fact, that is your duty, your ethical and moral obligation. With that as your guide, you simply cannot ignore the facts presented herein, safe in the knowledge that consensus currently supports you. Current care is substandard. Afrezza is a quantum leap forward. Of course, we encourage others to conduct their own studies. Develop the data for yourselves. Challenge our conclusions. We are quite confident what you will find. We know our protocol sounds revolutionary, some might even say irresponsible. But those who say such things do so without the benefit of the facts. They are responding to emotion not data, habit not science. Our interest is in the facts, and the best possible care for diabetics, not fealty to precedence, consensus opinion, or political or economic pressure. Doctors considering our recommendations might benefit from the advice of the renowned, German mathematician, Carl Jacobi, who counseled in trying to solve a difficult dilemma, “Invert, always invert.” So, imagine, if Afrezza had been developed first, would anyone bother with all the other medications currently in use? At this writing, Vdex is one of the largest prescribers of Afrezza. Hope Vdex can get more funding to set up additional clinics at major cities around the U.S. Endos need to get a little competitive pressures. |
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Post by wgreystone on Jul 30, 2017 13:04:53 GMT -5
All I can say is ... I'm transferring $$$ into my account to load up before the Aug. 7th conference call. If I had any dry powder - I'd def be buying. JAN2019 out-of-money call options are still very cheap. |
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Post by saxcmann on Jul 30, 2017 13:40:36 GMT -5
Indeed. It's high time we smelled the stench of burning white coats and less oft used stethescopes. Any MD in the US could have done what VDEX did in perhaps a better written paper with additional clarity AND without the need for an IRB approval. Such white paper would have had the same aim - attract patients to their practice. Last I checked, there is NO LAW against doing fine work outside of a clinical trial to push science beyond the traditional sponsor/investigator funded trials. None. So I repeat, white coats to the fire. The problem isn't the white coats. You don't want your doctor following white papers. You want your doctor to follow tried and true, peer-reviewed and meta-analysis papers. The problem is that MNKD needs to get the FDA on board with all of these claims. I have a cousin who is a diabetic NP and she is watching and waiting for Afrezza to be safe before she prescribes. I asked her how long she needs to wait before she feels safe- her answer- once there is a long-term safety study that signs off on it. You can find all sorts of doctors out there- What separates them from the witch doctors in Africa is their conservative approach to proven medicine. For better or for worse, I'm sure you would prefer a Western doctor to an African witch doctor. As has been said on here many times, the first oath a physician takes is to first do no harm. Whether you want to argue that prolonging Afrezza is doing harm is your prerogative. However, in the face of effective treatment, doing no harm means to make sure it is safe before prescribing. That weight falls on MNKD and MNKD alone. Sophie, your cousin is clueless. My endo friend is very conservative and extremely knowledgeable about diabetes and he prescribes afrezza already. Afrezza is safe. Period! |
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Post by brotherm1 on Jul 30, 2017 13:52:06 GMT -5
Oath to do no harm? Give me a break. Look who started today's massive opioid epidemic. Sorry, please continue.
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