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Post by joeypotsandpans on Sept 23, 2014 5:01:37 GMT -5
Don't get excited by the following title as it is not referring to Afrezza, on the contrary what is amazing is the author totally omits Afrezza from his article. What is even more amazing is the ignorant comment from the contributing SA writer named "Investing Doc", here is an example of an excerpt from his comment: "I think the competitive threat from inhaled insulin has been wildly overstated. Afrezza itself will have to establish clinical efficacy and safety and will also have to compete against entrenched subcutaneous insulins and novel oral hypoglycemic agents. If you think inhaling a liquid up your nose is more pleasant than a 30 gauge needle, you should try doing it three times a day. I don't mean to say that Afrezza won't be appropriate for some patients, but it's not the end-all be-all." seekingalpha.com/article/2510405-sanofis-new-drug-is-potentially-a-game-changerWhat the article does point out is more in line with supporting what I have posted in the past regarding the paired trade SNY/NVO and since then you can see SNY has already made all time highs over the last week. The chart on SNY looks extremely constructive at this point IMO.
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Post by dreamboatcruise on Sept 23, 2014 12:11:00 GMT -5
Hashimoto's syndrome (auto-immune disorder) is a common form of hypothyroidism, one with which I am personally familiar, where TSH indeed becomes elevated if the disease is not properly treated with synthetic thyroid hormones. This is because deficiency of the thyroid itself is the source of the problem. Low TSH can be the source of hypothyroidism if something effects the pituitary.
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Post by jpg on Sept 23, 2014 22:44:41 GMT -5
Yes a better article. From what I understand the first article added a small personal 'editorial explanation' which happened to be wrong and shows shallow understanding of central vs peripheral (autoimmune etc) hypothyroidism. Quote from first article: Prolonged, this condition can result in more serious conditions like heart disease and goiter (swollen thyroid gland which produces a lump in the throat), as well as pregnancy problems and ultimately a life-threatening condition known as myxedema coma. This above statement about goiter happens to be absent from the other link you provide. Basically if the first article was accurate Metformin would have a central TSH (no TRH available though) suppressing feature and somehow would also separately cause goiter. Two very different pathologies. This is at best unlikely. The interviewed MD in the second article rightfully seemed to suggest both TSH and TRH would have needed to be measured to help figure out what is going on. Then again this low TSH was only present, if I understand the second reference correctly, in patients treated for hypothyroidism and relatively uncommonly. Overall I would say this moves the needle (for me anyway) on prescribing Metformin about just about insignificantly. Like one of the MDs said : there are millions taking both and it's not as if there is an epidemic of whatever. As we always say when we don't know what to say about something being clinically important or not: further studies are required! This is not a smoking gun against Metformin... JPG
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Post by thekindaguyiyam on Sept 25, 2014 15:03:19 GMT -5
Hashimoto's syndrome (auto-immune disorder) is a common form of hypothyroidism, one with which I am personally familiar, where TSH indeed becomes elevated if the disease is not properly treated with synthetic thyroid hormones. This is because deficiency of the thyroid itself is the source of the problem. Low TSH can be the source of hypothyroidism if something effects the pituitary. likewise. some lucky 3% also have a secondary blessing of fibro as a bonus.
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Post by dreamboatcruise on Sept 25, 2014 15:53:46 GMT -5
Hashimoto's syndrome (auto-immune disorder) is a common form of hypothyroidism, one with which I am personally familiar, where TSH indeed becomes elevated if the disease is not properly treated with synthetic thyroid hormones. This is because deficiency of the thyroid itself is the source of the problem. Low TSH can be the source of hypothyroidism if something effects the pituitary. likewise. some lucky 3% also have a secondary blessing of fibro as a bonus. Mine kinda stalled out now for a long while. The doctors basically said it would likely require steady increase in dose until, as one colorfully put it, "you have a lump of scar tissue where your thyroid once was". Guess for some reason the process dramatically slowed. Probably something really interesting if one could figure out why.
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Post by seanismorris on Sept 26, 2014 0:16:56 GMT -5
Interesting discussions www.mmm-online.com/fda-social-media-guides-draw-industry-user-criticism/article/373571/Two FDA guidance documents on how health product manufacturers may participate in social media have each drawn criticism from affected industry and consumer groups. Both documents, one on presenting risk/benefit information on Internet/social media platforms with space character limitations and the other on dealing with misinformation about products by third parties, were published in June. Among comments on the character limitations draft guidance, the industry-funded Washington Legal Foundation (WLF) expressed “grave concerns” about several provisions in it. “Although FDA does not say so explicitly,” WLF wrote, “the gist of the draft guidance is that manufacturers should rarely, if ever, attempt to use Internet/social media platforms with character space limitations because those limitations do not provide manufacturers with sufficient space to include all the risk and benefit information that FDA asserts is a necessary part of any such communications. “The de facto prohibition on use of such Internet/social media platforms is inconsistent with FDA's statutory mandate and raises serious First Amendment concerns regarding the rights of manufacturers to speak truthfully on important healthcare issues.” WLF called on FDA to withdraw the document in its entirety and replace it with one that “respects statutory and constitutional constraints on FDA's authority.” Pharmaceutical Research and Manufacturers of America (PhRMA) blasted FDA for what it described as a double standard as regards dealing with character limitations. Specifically, PhRMA said FDA's own Twitter posts don't follow the restrictions that the agency is attempting to impose on industry in the draft document. “FDA's own actions—including the use of links to present risk information and general descriptions of the benefits of drugs—provide reasonable standards for appropriate use of these media,” PhRMA wrote. “Significantly, the limitations FDA recommends cannot withstand basic First Amendment scrutiny, because there are less restrictive means of ensuring that information presented on these platforms is truthful and non-misleading. Moreover, it cannot be truthful and non-misleading for FDA to use character-space-limited platforms in one way, but misleading for biopharmaceutical companies to do the same.” Meanwhile, in separate comments on the related guidance about correcting third-party misinformation on the Internet, PhRMA faulted FDA for assuming that manufacturers can be held accountable for such content if a company merely influences the third party. “By limiting the scope of the guidance in such a way, FDA‘s draft guidance, perversely, is likely to result in more inaccurate information about medicines online that will go uncorrected.” PhRMA said the draft guidance also appears to recognize that some statements on social media correcting misinformation are neither labeling nor advertising, but fails to give guidance as to what kinds of statements would be regulated as such. “The draft guidance should expressly recognize that many statements on the Web are not labeling, that non-promotional statements are not advertising, and that many statements correcting misinformation will be neither,” it said. Representing large medical-device manufacturers, AdvaMed commented that abbreviated format platforms are generally viewed as gateways for accessing additional information. “Such communications are an important means of providing information about device technologies, including those that are new and offer life-saving and life-enhancing therapies, to patients and healthcare professionals,” AdvaMed wrote. It called on FDA to take a more flexible approach that supports truthful and non-misleading information while better reflecting the unique attributes and use of Internet and social media tools and appropriate use of links to support such communications. The Biotechnology Industry Organization (BIO) complained that the character limitations draft document “imposes broad speaker-based restrictions on manufacturer communications” and reiterated its support for manufacturer First Amendment rights to truthful and non-misleading speech. Article Continues.... ---- We as investors would like companies like Mannkind to be able correct misinformation posted online... Legally it's a very difficult issue. If allowed, I could see Al getting himself in trouble every day of the week : )
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Post by mannmade on Sept 26, 2014 15:04:46 GMT -5
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Post by dreamboatcruise on Sept 26, 2014 20:00:23 GMT -5
So here are the numbers that this guy is modeling as flowing to MNKD. Using the current share count as conservative, this would equate to him modeling MNKD's 35% cut of profit as being worth $1.066 Billion in 2016. The cost of production in Danbury would already have been paid by the partnership. So from that $1.066 we subtract other expenses to come up with profit. Do we expect other expenses to balloon higher than the $150M a year level that it has roughly been at when Danbury was included? So it would seem this guy is predicting that in 2016 MNKD would have a profit of over $900M... and $1.2B in 2017. If we assigned a 12x multiple on 2016, which would seem incredibly low for the growth he shows, it would quadruple the share price. He recommends SNY because it is 20 some odd percent undervalued. How is MNKD not screamingly undervalued if it comes anywhere near the projections this guy is listing? What am I missing in his comparison of SNY vs MNKD? His numbers overall may be aggressive as 2015 certainly is outstripping current capacity of Danbury lines. --------------------- From the above linked article showing each companies cut of profits from deal as a per share amount (at least that is what I believe this table is meant to be) ---------------------- The Value of Afrezza - MNKD vs. SNY 2015 2016 2017 2018 2019 2020 MannKind $2.05 $2.77 $3.50 $4.27 $5.07 $10.88 Sanofi $0.49 $0.67 $0.84 $1.03 $1.22 $2.62
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Post by brentie on Sept 29, 2014 8:49:19 GMT -5
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Post by liane on Sept 29, 2014 8:59:54 GMT -5
Shorts on StockTwits having a field day with this - like it came out of the blue.
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Post by joeypotsandpans on Sept 29, 2014 9:33:20 GMT -5
Shorts on StockTwits having a field day with this - like it came out of the blue. They can't be having too much of a field day according to this: Shortable Stocks for United States Key Search: Last updated: Mon, 29.Sep.14 10:14EDT Symbol Currency Long Name MNKD USD MannKind Corp Check Availability Symbol: MNKD Availability: 35'000 Exchanges: NASDAQ
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Post by jpg on Sept 30, 2014 20:09:24 GMT -5
Shorts on StockTwits having a field day with this - like it came out of the blue. They can't be having too much of a field day according to this: Shortable Stocks for United States Key Search: Last updated: Mon, 29.Sep.14 10:14EDT Symbol Currency Long Name MNKD USD MannKind Corp Check Availability Symbol: MNKD Availability: 35'000 Exchanges: NASDAQ That doesn't seem to bother shorts to much? They just seem to somehow just bring down the price on any positive news. They are conditioning us not to expect any upside. Are they naked shorting to do this? Who is selling or are they simply 'walking down' the price? JPG
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Post by savzak on Sept 30, 2014 21:04:41 GMT -5
"They are conditioning us not to expect any upside."
I don't know whether "the shorts" are responsible but I can corroborate that after 6 plus years of holding MNKD through thick and through thin I am jaded. The double trophies of approval and partnership that I waited years for resulted in jack. Actually, worse than jack. Jack minus.
I'm still in and logically, still optimistic for our prodpects. Emotionally and psychologically, I'm pretty much spent.
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Post by jpg on Oct 1, 2014 2:03:48 GMT -5
"They are conditioning us not to expect any upside." I don't know whether "the shorts" are responsible but I can corroborate that after 6 plus years of holding MNKD through thick and through thin I am jaded. The double trophies of approval and partnership that I waited years for resulted in jack. Actually, worse than jack. Jack minus. I'm still in and logically, still optimistic for our prodpects. Emotionally and psychologically, I'm pretty much spent. This is the aim of this battle... The conditioning is a sort of Pavlovian Response. Imagine if you are short a few millions shares how you must feel right now? What would be your exit strategy? I've been invested in Mannkind for easily 5-6 years and am wondering when the moment of capitulation comes up? That would be when to buy again. Are we there yet? From reading this board: maybe? JPG
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Post by ezrasfund on Oct 1, 2014 8:58:56 GMT -5
There is another side to the story. There are apparently no significant investors interested in taking a large stake in MNKD, even at these prices. When a company's market cap is $2.5 billion it takes a lot more than some deep pocketed retail investors with $1 million of MNKD shares to make a difference. I believe that one reason for this is Al's strategy of maintaining complete control of the company. Frankly, I never thought this would go below $10/share after approval and partnership.
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