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Post by spiro on Mar 16, 2014 5:53:03 GMT -5
harshal1981, If you go back and look at a one year chart for MNKD and compare it to the biweekly short interest chart, notice that the days to cover was particularly high preceding each nice jump in share price. This is indicative of possibly the shorts feeling squeezed. I have noticed with the increased short position and the recent sluggish volume, the days to cover has increased substantial. This may not create a short squeeze, but it certainly bodes well for the longs if we get a positive AdCom. So it now looks like the longs are concerned about the what if's, while the shorts are worried about the overwhelming facts supporting a potential blockbuster. But of course, what do I know, my optimism is off the chart. as usual.
Spiro
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Post by spiro on Mar 15, 2014 20:35:36 GMT -5
I am sorry to keep bringing up the old stuff, but someone has to do it. I think the shorts have a lot more to be concerned about at this time. Try this one, the short interest has been increasing dramatically the pas 2 months, but the share price is still $5.63. Available shares to short are extremely low and institutions are loading up. The days to cover is approaching record highs causing the noose to tighten. If I am wrong on MNKD, I know exactly how much money I can lose. If the shorts are wrong they are clueless as to how much they will lose. If I am right and MNKD becomes a huge success, then I will be clueless as to how much money I will make. Hmm, but if the shorts are right, they will make $3-$4 a share after hedges. i will lose $3 a share. You know what, I like my position a lot better and at least I have the facts on my side. seekingalpha.com/instablog/6050591-us-investor/2550421-20-reasons-why-mannkinds-afrezza-is-superior-to-novolog-humalog20 Reasons Why Mannkind's Afrezza Is Superior To Novolog/Humalog 5 comments Jan 7, 2014 11:11 AM | about stocks: LLY, NVO, MNKD Mannkind's (MNKD) lead drug Afrezza is nearing the PDUFA date of 15-Apr-2014. Afrezza is an inhaled insulin for use during meal times. Mannkind has submitted the NDA for the 3rd time. Here are the 20 reasons why Afrezza is superior to its nearest competitors Novolog/Humalog. Novolog is marketed by Novo Nordisk (NVO) and Humalog by Eli Lily (LLY). 1. Afrezza is ultra-rapid acting insulin with a pharmacokinetic profile that mimics endogenous secretion of insulin. In plain English, Afrezza works like body's natural secretion of insulin by pancreas during meal time. Novolog/Humalog are called rapid acting analogues and don't even come close. The reason for the ultra-rapid acting is due to the fact that Afrezza has monomeric insulin. 2. Afrezza is delivered by a sleek device that is discreet, portable and easy to use. Novolog & Humalog are delivered by injections. The inhaler is disposable. 3. Afrezza has lower post-prandial glucose excursions. Hence it results in lower long term diabetic complications. 4. Afrezza requires little or no titration compared to Novolog/Humalog. There are no correctional dosages needed. The accurate card counting would be a thing of the past. 5. Afrezza requires less blood glucose (BG) level testing. This is one of the major pain points of diabetics. A typical diabetic needs one or more correctional insulin shots after a heavy meal and 3-4 times BG testing. 6. Afrezza reduces the stress on pancreas as it takes the load off the pancreas. The hyperglycemia is less pronounced for Afrezza users. (see pg. 7). Brief glucose excursions outside the normal physiological range are especially damaging to β-cells. Afrezza helps the pancreas live longer. 7. Afrezza patients will show better compliance. This reduces the long term diabetic costs. Recent survey indicates that 1/3rd of patients fail to take insulin as prescribed. 8. The physicians can initiate insulin therapy earlier with Afrezza. 9. No injection site complications like lipodystrophy, pain, redness, irritation and no need to keep track of injection sites for rotation. 10. No post meal snacking and weight gain with Afrezza. The post meal snacking is a feature of Novolog/Humalog that causes hypos due to long tail. 11. Afrezza shows much lower incidences of hypoglycemia. According to this article, One in 20 people (an estimated 2-4 percent and 6 percent in patients younger than 40 years old) will perish from severe hypoglycemia. 12. Afrezza offers lower costs in the long run if we consider the reduced BG tests, no correctional dosages, better compliance and reduced long term complications due to lack of hyperglycemia. 13. The Griffin research mentioned earlier says that prophylactic use of Afrezza prevents type 2 diabetes. It is a hard sell to use deploy prophylactic use of Novolog/Humalog 14. Survey of patients who participated in Afrezza trials reported higher satisfaction rates 15. Anecdotal evidence from trial patients who used Afrezza reported better HbA1C. In some recent trials, Mannkind was able to show superiority in A1C. You can read more about the background on A1C in this article as well. 16. Due to superior kinetics, Afrezza shuts off the hepatic secretion of glucose. The body needs less insulin during meal time. 17. Patients need less training, Afrezza is easier to learn and use 18. Obese patients will show better glucose clearance with Afrezza. Children who take meal time insulin will be less traumatized. The FDA has approved pediatric trials for Afrezza. 19. Afrezza is a God sent for needle phobic patients. 20. Afrezza is easier to use for visually impaired patients and for patients with various disabilities. Afrezza, if approved will give the current rapid acting analogues a run for its money. Al Mann, the CEO of Mannkind corp says that Afrezza will be the greatest medical product in history. The potential market size is just enormous. According to the recent Canaccord presentation, the potential patient population in U.S. alone includes · 3.2 million on prandial insulin · 1.9 million on basal insulin as the only insulin · 12.6 million on oral agents alone And let's not forget. klljinvestments.blogspot.com/p/afrezzas-market-potential-and-future.htmlAnd then there's this one. www.3dimensionalresearch.com/news/detail/Three-Relatively-Low-Hurdles-Left-for-MannKind
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Post by spiro on Mar 14, 2014 17:38:00 GMT -5
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Post by spiro on Mar 13, 2014 13:39:29 GMT -5
Interesting analogy, she is most likely correct. The shorts are having a little trouble borrowing shares to sell. C.S. is now paying 2% to borrow shares. I told them to call me back when it reaches 8%. With the days to cover now over 10, the noose is tightening on the shorts.
kathleen74321 • 2 hours 48 minutes ago 40users liked this postsusers disliked this posts2Reply Warning: MannKind tsunami on the horizon. With the pps of MNKD temporarily receding I am reminded of the well know properties of a tsunami. Minutes before a tsunami can be seen on the horizon the ocean tide frequently recedes so far and rapidly that tens of thousands of fish are left flopping on the bare wet sand for miles along the shore's beaches.
Unsuspecting locals can be seen giddly scooping up the flopping bounty and laughing at their seemingly good fortune. Soon others arrive with large woven basket to take full advantage of the golden opportunity.
Nobody is aware of the massive swell that is just beginning to peek over the horizon or the ungodly strange, deep and distant low-level roar that is getting lounder by the second. Everyone is bent over and focused on gathering as many fish as they can before others come to share in the bounty.
But suddenly a huge shadow is cast over them and they are now keenly aware of a deafening roar. They turn and look up. They are horrified. A monsterous six-story wave is about to slam on the beaches with the fury and destruction of 10,000 atomic bombs. They drop their fish and baskets and run even though they know escape is futile.
The wave crashes and explodes. The ground shakes and tremors can be felt five miles inland. The wave is now an eighty foot high mass of roiling white water surging inland and destroying everything in its path. Thousands of bodies are being slammed to the bottom time and time again as the roiling waters churn with unimaginable fury.
Nobody on the beach survived. Their broken and unrecognized bodies are later discovered amongst massive heaps of destruction that continue for miles and miles.
Fair warning shorts. MannKinds's pps recedes and you scoop up a few nickels and dimes of profit, beware the MannKind tsunami is coming and there will be no warning. A revolution in diabetes treatment will be a reality. That day 50-90 million shares will be traded and the pps will surge into the stratosphere. Cheers.
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Post by spiro on Mar 11, 2014 15:22:35 GMT -5
Up again, with a favorable AdCom, some sort of squeeze is inevitable. With the lighter volume lately, the days to cover is probably closer to 10 now. This should make the shorts a little uneasy, since they prefer this number to be around 4 or less. # avg vol days to cover 2/28/2014 59,244,446 8,143,101 7.275416 2/14/2014 58,118,039 5,938,771 9.786206 1/31/2014 57,387,598 6,549,011 8.762788 1/15/2014 51,450,894 11,687,637 4.402164 12/31/2013 47,463,406 4,039,868 11.748752 Read more: www.nasdaq.com/symbol/mnkd/short-interest#ixzz2vgfBYEuE
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Post by spiro on Mar 11, 2014 10:12:56 GMT -5
Babaoriley, OK, maybe on golf and Miami Heat basketball, but definitely not kayaking.
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Post by spiro on Mar 11, 2014 9:24:42 GMT -5
Kathleen's response to George Rho. I could never win an argument with her.
Kathleen74 Comment (1) Dear George, Thanks for your clear, balanced assessment of what lies ahead with respect to Mannkind. I always enjoy reading your articles. As you may have guessed, I am the Kathleen referred to in your piece. Thanks for your kind words. Readers should be aware that yesterday (Sunday) Feuerstein blocked me from posting on his blog what were intended to be my final comments regarding his piece on Mannkind. Here is what I attempted to post (several times) as a response to his last exchange with me: "Adam, I am not going to engage in a silly tit for tat here. You miss the point of my response to your article which was to separate out the fact that you provided from the negative conjecture and innuendo - and what I perceived to be blatant attempts to mislead the reader. I'll post after PDUFA - either to put together a case for why Afrezza has huge market potential - that is where my background and experience (emphasis on the latter) will be put to good use, or to admit that I was wrong in my expectation that Afrezza had a good chance to be approved. I have no illusions here. I realize that I could lose the bulk of my investment in Mannkind if it suffers another FDA rejection, but I have not yet seen a cogent bear case that holds water. I truly would love to see one. I don't want to lose money that I don't have to - I have more in this speculative play than I would have normally put into one, but I believe it is worth the risk." George, thanks for the opportunity to post my comments intended for Feuerstein here - and thanks for your insightful ongoing commentary regarding Mannkind. 10 Mar, 03:07 PMReply! Report AbuseLike21
George Rho , Contributor Comments (395) Author’s reply » Hi Kathleen74, Thank you for your kind words. Thank you also for the comments you posted on AF's article, I thoroughly enjoyed the back and forth between you two, even though I don't normally appreciate mismatches. I almost felt bad for Adam. Any thoughts about taking the baton and writing the next article on MNKD?
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Post by spiro on Mar 10, 2014 14:09:55 GMT -5
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Post by spiro on Mar 10, 2014 8:30:15 GMT -5
Babaoriley seems to be intimidated by the Boogeyman. BTW, Ashiwi, my kayaking skills were excellent, I didn't fall in the water until I was trying to get out of the damn thing.
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Post by spiro on Mar 9, 2014 21:12:10 GMT -5
Yes, I know $50 may seem a little conservative, considering the monstrous size of the diabetes worldwide market, not to mention the value of Technosphere particular in the pain market. When you consider that if everything goes right, MNKD could have over $10 billion in worldwide sales within 6 or 7 years, I guess $50 a share would seem to be quite a bargain to a big pharma company getting ready to lose patent protection on a $7 billion a year drug. Or maybe they would like to spend $5 billion or so developing a new drug from scratch. OK, but I'm not greedy, I will take $40, but that would make me a little disappointed, but happy.
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Post by spiro on Mar 9, 2014 18:29:31 GMT -5
You guys are too much! I believe the Yoda on this one. Fear leads to Anger, anger leads to hate and hate leads to selling. OK, maybe he said suffering. Up until today, I thought Dr. Rasmussen ran a polling firm. What is he doing on our AdCom? Personally, I don't care who this guy Rasmussen works for, the AdCom will vote in favor of approving Afrezza, by a huge margin. Furthermore, i have come to the conclusion that big pharma is not interested in partnering with MNKD. I now believe that they prefer an outright buyout of the entire company. This will happen very soon after approval. depending on the label, I am predicting a buyout price of somewhere between $50 and $75 per share. These big drug companies know that if they partner first and then Afrezza becomes the expected blockbuster in 2 or 3 years, a buyout will cost them 3 or 4 times more because of the added potential of the Technosphere pipeline. Also, GLP 1 with Technosphere delivery could prove quite valuable in the future. Al Mann will still have skin in the diabetes game, because one of his private companies is working on another potential monster in the basal insulin patch. MNKD is so undervalued at $5.71 it is ludicrous. It's time the longs start manipulating the share price, the shorts have had there way for too long. I am officially fired up now and will be buying more calls on Monday and Tuesday.
Spiro
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Post by spiro on Mar 7, 2014 9:34:44 GMT -5
This Kathleen lady knows how to rip someone apart. If I were smarter, I would have said the same thing. I hopes she finds our board and starts contributing here.
Biotech Stock Mailbag Extra: MannKind's Afrezza Panel Setup - Adam's Biotech Beat - TheStreet
Kathleen • 12 hours ago So with all those important things you are involved in (I checked "your" bio online) you found time to post on a blog in the middle of the day. Why, you even "know" that Adam has never shorted a stock. Too funny.
Kathleen • 13 hours ago I googled him too. Perhaps someone should call Dr. Karpf to see if was actually he who posted on this blog. I have my doubts.
Kathleen • 13 hours ago As a follow-up to my earlier post outlining my concerns with Adam's analysis, I would like to say that I expect more out of The Street than articles such as this. As an investor, I count on The Street objective, fact-based analysis with conclusions drawn from an assessment of those facts. I have no problem with contrarian opinion, so long as there are facts to back it up. And as a special note to Adam, I hope that you stick to the facts and dispense with the childish commentary as evidenced by your tweets from the JPM Conference (you know what I mean), when you blog from the FDA panel. Your readers deserve nothing less.
Kathleen • 14 hours ago Correction - numbers 4 & 5 should be 3 & 4. Missed that in my editing.
Kathleen • 14 hours ago Adam, as a former market strategy consultant with Fortune 500 companies, former corporate senior executive and Harvard MBA I find your case against Mannkind less than compelling and at times totally without merit. Normally, cases are made using concrete facts - and in the case of quantitative studies, using significantly significant findings, not conjecture and spin (or as they call it in the ad business, weaseling). While there are some facts in your analysis, your use of conjecture and spin intended to appear as facts is especially troubling. Let me address your case point by point.
Adam: "Maybe MannKind totally mis-read the situation and FDA always intended to convene a panel for Afrezza."
OK - what if Mannkind misread the situation? So what? Does that count against Afrezza with respect to FDA approval? Your use of the word "maybe" suggests that you really don't know the facts which, in this case, if they existed, are irrelevant.
Adam: "Or, maybe some time between last fall and January, MannKind received feedback from the FDA suggesting the agency had serious problems with the new Afrezza phase III data."
Seriously, is this what you consider fact? Again, your use the word "maybe" demonstrates pure conjecture on your part. In fact, it seems like a blatant attempt to foster serious misgivings about Afrezza's phase III data. Where is your proof? Feel free to provide it. There are many who have serious money invested in Afrezza who deserve to know.
Adam: "In Type 1 diabetics, Afrezza was numerically worse than Novo Nordisk's (NVO) Novolog."
Interesting that you had to use the word "numerically" and not the words "statistically significant." That's called a weasel, intended to imply that the differences were meaningful when they were not. In any legitimate quantitative study, findings need to show statistical significance, not a numerical difference. The statement should read "In Type 1 diabetics, Afrezza performed at parity to Novolog.
Adam:"The study met its primary endpoint -- barely -- only because MannKind set a low bar with respect to the statistical non-inferiority endpoint."
Congratulations Adam, you presented a fact. The study did meet it's primary endpoint. End of story. However, correct me if I'm wrong, didn't Mannkind develop the study and endpoints in conjunction with the FDA? If it's good enough for the FDA to be statistically non-inferior (or parity), then it should be good enough for us laymen, yes?
Adam: "Results from the study in Type 2 diabetics were more favorable for Afrezza but still, the product under-performed relative to MannKind's expectations."
Excellent, another fact: Results from the study in Type 2's were more favorable for Afrezza. Period. How it performed relative to Mannkind's expectations, assuming you even have evidence of what those expectations were, is a non-starter. The bottom line is the results overall were more favorable than Novolog.
Adam: "Afrezza also caused more weight gain in Type 2s."
You're correct. However, you left this out: Afrezza caused less weight gain vs. rapid-acting analogs (according to Mannkind). How this information impacts approval remains to be seen. I look forward to the FDA's opinion.
Adam: "We still don't know, exactly, how the current "Dreamboat" inhaler performed relative to the older Medtone inhaler."
You're right, we don't. But that was not the purpose of the study. The purpose was to ensure that Afrezza was efficacious with respect to the new, improved Dreamboat inhaler. The study met it's endpoints - end of story.
Adam: "We know the inhaled insulin causes a persistent cough. MannKind claims the cough is benign, but what will FDA say?"
Correct me if I'm wrong, but isn't the word PERSISTENT your word? This is contrary to what Mannkind presented as a finding: "The most common respiratory side effect experienced with Afrezza in trials was a mild, transient, non-productive cough. Discontinuation due to cough was uncommon." Whom should I believe, those involved with the trials and having access to the full data, or you? I guess we'll find out. I definitely want to hear what the FDA will say.
In summary, based on only the FACTs that you presented (and not all of the facts presented by Mannkind), here is what we know:
1. Afrezza met its primary endpoints in the trial.
- Afrezza performed at parity to Novolog in Type 1's.
- Afrezza performance vs. Novolog was more favorable in Type 2's.
2. Afrezza caused a cough, but there is a dispute between Adam and Mannkind as to how that cough is characterized.
- Mannkind characterizes it as benign. - Adam, who was not at the trials and admittedly not privy to all of the data, characterizes it as persistent.
4. Afrezza caused some weight gain in Type 2's. (No information provided by Adam re Type 1's but Mannkind says that Type 1's experienced less weight gain vs. rapid-acting analogs.)
5. Adam does not have enough information to assess product safety.
In addition to those conclusions, here are some additional facts, according to Mannkind, that readers might find relevant. (Adam, if you have data to contradict these findings please feel free to provide.)
1. Use of Afrezza resulted in a reduced risk of hypoglycemia vs. rapid-acting analogs. 2. Afrezza demonstrated reductions in HbA1c. 3. Afrezza delivers insulin without the use of injections.
Thank you for allowing me the opportunity to respond to your article. I look forward to any additional information you can provide, including factual evidence of mis-characterizations on my part. I am open-minded and willing to be proven wrong. After all, I have real money invested in Mannkind.
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Post by spiro on Mar 5, 2014 11:02:39 GMT -5
Ok, IMO type 1 is a slam dunk and will be approved. Do you think the type 2 data is good enough for approval? What issues do you think the FDA may focus on with this data?
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Post by spiro on Mar 5, 2014 9:45:30 GMT -5
Welcome to the board, I am glad you found us. This is a great board, with a lot of good people posting. i am not too concerned about the Deerfield situation and find it mostly a distraction to the real issue of whether or not Afrezza gets FDA approval. It would be great if you could share your opinion with the board, regarding the results of the 171 and 175 trials.
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Post by spiro on Mar 3, 2014 17:35:21 GMT -5
Goyo, I guess we are bored and playing the connect the dots game. i would rather go back and read this stuff than to focus on a useless hit piece written by some screwball.
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