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Post by mnkdfann on Jun 14, 2016 11:20:09 GMT -5
It's incredibly annoying that Afrezza has to carry a warning about cancer when the initiation of that cancer is caused by another inhalation drug with extreme ADRs that you can buy at any corner grocery store. A number of inhaled substances are linked to cancer. Above and beyond any ingredients in tobacco products. So I think the FDA's concern (valid or not) about inhalants and cancer is rooted in more than just considerations due to tobacco.
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Post by Deleted on Jun 14, 2016 16:23:22 GMT -5
The FDA cares very little about the safety of the public. The FDA will have complete regulatory control over all tobacco products starting August 8, 2016. Guess what? It's still not going to do anything to regulate what goes into cigarettes. Cigarette conpanies profit millions, are trade on the stock market (which is sickening), and thousands of people die every year from direct consequences of what the FDA "cares" to regulate. If the FDA cares about anything it's making the FDA more money. I mean no disrespect towards you, I'm just speaking out loud so please do not take offense, I value your input and knowledge on this forum. This is directly from the FDA website: " Tobacco use is the single largest preventable cause of disease and death in the United States. As part of its goal to improve public health and protect future generations from the risks of tobacco use, the FDA has extended its authority to cover all products that meet the definition of a tobacco product." The FDA is already spreading misleading information by claiming tobacco to be the direct cause of death and diseases like COPD. It's what is IN cigarettes in addition to tobacco that does this. Tobacco is natural, but is altered with harmful ingredients that effect even those whom do not smoke cigarettes via second hand smoke. People die every year from second hand smoke related conditions. Here is what the FDA thinks of their achievement: " This action is a milestone in consumer protection – going forward, the FDA will be able to: -Review new tobacco products not yet on the market; -Help prevent misleading claims by tobacco product manufacturers; -Evaluate the ingredients of tobacco products and how they are made; and -Communicate the potential risks of tobacco products. www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm388395.htmTo get an idea about how corrupt and hypocritical the FDA is here is one of the FAQ regarding their regulation of tobacco: — Question: How does the regulation of tobacco products differ from FDA’s regulation of drugs or medical devices?—Answer: FDA's regulatory role for drugs and devices is usually based on a safety and effectiveness standard. The tobacco control act establishes a new standard: to regulate tobacco products based on a public health and population health standard. www.fda.gov/AboutFDA/Transparency/Basics/ucm194451.htmAnd then there is this: The decisions made by FDA in the regulation of tobacco products are grounded in science. —FDA's traditional "safe and effective" standard for evaluating medical products does not apply to tobacco products. FDA evaluates new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole, including users and nonusers The FDA again is lying to the public and spreading false information. Tobacco products must be pretty safe, seeing how the FDA claims they made make their regulatory decisions of tobacco products grounded in "science", and despite millions that die every year they also base these same decisions on public health. You cannot get anymore sinister than that. www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm283974.htmNice rant, mango, but I think your ire is misplaced. The real mission of FDA is to not run afoul of Congress. That's where the big money exchange takes place. How can FDA effectively regulate the tobacco companies when their bosses are collecting millions from the perps? It's incredibly annoying that Afrezza has to carry a warning about cancer when the initiation of that cancer is caused by another inhalation drug with extreme ADRs that you can buy at any corner grocery store. It will be a good day when tobacco company executives and their puppets in Congress are rounded up and charged with conspiracy and mass murder. I was just making a single point, trust me, we are on the same page. This is how things work: •Altria Group Inc. (one of the largest tobacco and cigarette companies. Also, Kraft Foods (now Kraft Heinz) comes to mind) —Two specific board members of Altria are George Muñoz and Gerald Baliles. —Gerald Baliles is a former Governor of Virginia, an attorney, and has worked directly with the government, specifically Bill Clinton —George Muñoz was Assistant Secretary and CFO of the US Treasury Department from 1993 -1997, and was appointed to the President's Commission on White House Fellows by Obama in 2009. —FDA was first granted regulation over tobacco on June 22, 2009 *The White House released a press release on June 17, 2009 and George Muñoz was one of the 28 appointed to the President’s Commission on White House Fellowships by Obama •How this is significant: The Tobacco Control Act does not: The law makes clear that FDA's role is to regulate and protect the public health, but it places a few restrictions on FDA's powers. FDA cannot: -Require prescriptions to purchase tobacco products. -Require the reduction of nicotine yields to zero. -Ban face-to-face sales in a particular category of retail outlets. -Ban certain classes of tobacco products.
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Post by anderson on Jun 14, 2016 18:49:50 GMT -5
If you go further back the original insulin used for Afrezza was produced by Merck. Merck's insulin business was purchased by Amphastar in 2014 for $34.4 million. Since Merck's insulin was used in the trials that is what is approved. The Pfizer insulin(was this the left over insulin base for Exubera? Btw Sanofi got the plant) was a fire sale and they got tons at a very low price($3 million) as well as the manufacturing rights. Al said at the 2014 shareholder meeting that it is tested regularly and is still good. It kept viable from 2009-2014, also Sanofi used it as collateral for part of the loan. So I am guessing they know how to store it so that is does not degrade rapidly. www.marketvis.io/stock/amph/financial/q3-2015/note/businesscombinationdisclosuretextblockI finally got around to watching the 2014 shareholder meeting video linked to in the first post. Small point, it wasn't Al who said the insulin was monitored regularly, that was someone else. See the OP's link (it is queued up to the relevant question and answer). Al actually said as a follow-up to that person's answer that there was "enough in the freezer to do about 10 million patient years, but that doesn't mean we can use it all." It seems to me that none of us here know the current status of the insulin, all we can do is hope for the best. Correct it was Juergen A. Martens, Ph.D. Corporate Vice President of Operations and Chief Technology Officer that said that. Dr. Martens holds a bachelor’s degree in chemical engineering from the Technical College Mannheim/Germany, a bachelor’s and master’s degree in Chemistry and a doctorate in Physical Chemistry from the University of Marburg/Germany. So he probably knew what he was talking about.
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Post by mnkdfann on Jun 14, 2016 19:41:33 GMT -5
I finally got around to watching the 2014 shareholder meeting video linked to in the first post. Small point, it wasn't Al who said the insulin was monitored regularly, that was someone else. See the OP's link (it is queued up to the relevant question and answer). Al actually said as a follow-up to that person's answer that there was "enough in the freezer to do about 10 million patient years, but that doesn't mean we can use it all." It seems to me that none of us here know the current status of the insulin, all we can do is hope for the best. Correct it was Juergen A. Martens, Ph.D. Corporate Vice President of Operations and Chief Technology Officer that said that. Dr. Martens holds a bachelor’s degree in chemical engineering from the Technical College Mannheim/Germany, a bachelor’s and master’s degree in Chemistry and a doctorate in Physical Chemistry from the University of Marburg/Germany. So he probably knew what he was talking about. Thanks for identifying him now (so I'm not sure why you thought it was Al before, as you stated in an earlier post) and I'm sure he does know what he is talking about. I never insinuated otherwise. But just because Martens et al. know to test the insulin doesn't mean they have any magic way to extend its life expectancy. From the conference call, it seems they are aware that some of it may have to be trashed. Only time will tell how much. I don't see the point of this thread to be honest. We have no new information to work with. It was already known that Mannkind has a lot of stored insulin. Some of it will be used, likely some of it will be trashed. None of us have a clue as to what the corresponding amounts will be.
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Post by agedhippie on Jun 14, 2016 20:13:25 GMT -5
Frozen insulin, provided it was frozen and then maintained properly, will last almost indefinitely. Part of the sale was a contractual obligation on Mannkind to maintain the insulin which was imoprtant since most of it still belongs to Pfizer. Mannkind have an option on the balance of the insulin at what I expect is a good price.
The more immediate problem is that there is a contractual obligation to buy minimum annual quantities of Amphistar insulin. Until those minimum quantities are met the Pfizer insulin is irrelevant since the Ampistar insulin must be paid for regardless.
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Post by bradleysbest on Jun 15, 2016 10:36:39 GMT -5
I'm worried about the insulin produced in Danbury the last 2 years! Matt said we have too much inventory.... Let's get rid of that!
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Post by lakon on Jul 18, 2016 10:39:11 GMT -5
I'm worried about the insulin produced in Danbury the last 2 years! Matt said we have too much inventory.... Let's get rid of that! Replace with Afrezza. AFAIK, no insulin, human or other, is produced in Danbury. Besides being asked to create this thread by another on this board, the point of this thread is to remind everyone that MNKD has A LOT of insulin. Some of the insulin will not be sold, but the majority of the insulin can be expected for sale as Afrezza IF Afrezza ever becomes a blockbuster. The expenses are mostly baked in already for this insulin in deep freeze. Therefore, if you believe in MNKD/Afrezza long-term, add about $10 billion to your valuation minus whatever you think the marketing will cost. You can run models that convert marketing costs to time. Then, convert to present value. Right now, the market says MNKD/Afrezza is worth a whole lot less so the value of this insulin is likely less than they paid for it. If it ever becomes Afrezza, it's value to MNKD is much more. Eventually, this stockpile will be revalued: either for a few million or billions of dollars, whether Afrezza fails or succeeds, respectively.
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Post by mannmade on Jul 18, 2016 10:45:45 GMT -5
It must first be approved by the fda for sale at retail as I recall.
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Post by lakon on Jul 18, 2016 11:02:52 GMT -5
It must first be approved by the fda for sale at retail as I recall. Yes, there is a FDA process to get the Pfizer insulin approved as API for Afrezza. The fact that SNY never did this was a telltale sign (in hindsight) that they had no interest going forward. If MNKD starts the process, it will be a telltale sign that things are taking off and MNKD is reducing costs further.
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Post by brotherm1 on Jul 18, 2016 11:17:45 GMT -5
So we purchased insulin in 2009 from Pfizer for $3 million and it's now projected to be worth $10 billion? Is this the Yahoo board?
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Post by pengiep on Jul 18, 2016 11:23:32 GMT -5
Perhaps it would help for you to know some of the background about why that insulin was purchased from Pfizer in the first place. Remember Exubera? That insulin was produced for that product. When Exubera was killed, Pfizer had a sh*tton of insulin with no use. Hence they sold it to MNKD at a deeply discounted price.
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Post by mannmade on Jul 18, 2016 11:32:59 GMT -5
And the 10B valuation is based on retail sales of AFREZZA.
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Post by dg1111 on Jul 18, 2016 11:42:11 GMT -5
If Afrezza sales take off, there is a lot of potential to make a lot of profits in the next few years. This insulin stockpile and the tax losses carried forward mean Mannkind will have reduced expenses for a while. Hopefully there are sales/profits to allow us to realize this.
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Post by madog365 on Jul 18, 2016 11:45:01 GMT -5
correct me if i'm wrong, but i think i remember reading somewhere that the insulin can only be used in an inhaled application like Afrezza or Exhubera. Therefore, the insulin is only worth something to Mannkind unless another inhaled insulin maker enters the market.
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Post by lakon on Jul 18, 2016 12:27:00 GMT -5
correct me if i'm wrong, but i think i remember reading somewhere that the insulin can only be used in an inhaled application like Afrezza or Exhubera. Therefore, the insulin is only worth something to Mannkind unless another inhaled insulin maker enters the market. Yes, you are correct for MNKD as far as the manufacturing process license IF MNKD chooses to make the insulin API, eventually. It's all for inhaled insulin [Afrezza]. I don't recall whether or not the restriction applies to the stockpiled insulin that MNKD owns, but I think so. I would think that they could use it as Afrezza or sell it. I would doubt MNKD has other ideas that would run afoul of the intent of the deal, like a competing injectable. A pill would be interesting, but not likely anytime soon.
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