shanghai
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3/3/2017 17-0008 Area Business Manager Manhattan NY
https://rew12.ultipro.com/MAN1011/JobBoard/ListJobs.aspx?__SVRTRID=E6638DC6-11AA-42D5-AD9B-1690FEB7FB0D
Speak to be based, data, can not guess their own
I tell you what is nrx now? refills how much?
What does nrx mean? What does refills mean?
Your words are nrx»refills
But the actual is nrx«refills, every week
I asked a question: 4Q 2016 earnings is not the latest, why?
I asked a question: 4Q 2016 AFREZZA sales or 0.57 million dollars?
I ask a question: Sanofi, Eli Lilly, Novo Nordisk has a number of scripts every week?
Alfred E. Mann
Playing the piano against a cow
This is Chinese
In fact, this is a commercial operation
I talked about a story, about 1910, the Americans doing business in Shanghai, selling kerosene, the beginning of business is not good, then the Americans change the way to send kerosene lamp (buy kerosene), the last American success.
Now, how about the future of mnkd's business? One thing I firmly believe afrezza is a revolutionary product
Alfred E. Mann spent $ 1 billion (for you are astronomical) success afrezza
China has a word ---- on the cattle playing the piano (perfect for you)
China also has a proverb: a sparrow to see the eagle flying too high, that fly too high is not good, I fly low, from the ground near the convenience (you do not think you are too like a small sparrow)
http://www.cbs58.com//story/34642667/special-report-inhalable-insulin#.WLga9I_FEUY.twitter
Cbs is a lie?
Thousands of people use afrezza for two years is a lie?
Who saw sfrezza had a medical accident?
New things come to power, old bad things to step down, this is the law of the world
Money is not a problem for me
Time is not a problem for me
But the money for you is the problem, the time for you is a big problem
Do you know the laws of the world?
New birth, old left
Just as you are going to leave, we are mastering the world (no matter how you struggle, the world is running it like this)
Do you know afrezza the biggest, the best is what?
Afrezza listed for two years, no medical malpractice, no negative news
Afrezza is a great product,
Afrezza will master all the diabetes
The first ever diabetes t.v. reality show now casting for type 1 and type 2 diabetics hosted by celebrity chef Charles Mattocks
Just followed me on Twitter.
https://twitter.com/CMattocks1?ref_src=twsrc%5Etfw
www.charlesmattocks.com/about
Google "PRN VMS inhaled insulin," and you will discover lots of new job openings nationally. See link below. If there is anyone with addional remarks, your thoughts are welcome....
usa.jobs/virtual-usa/prn-contract-clinical-educatordiabetes/5605E75B37E840A793F6BFB94770403F/job/?utm_campaign=.JOBS%20Sitemap%20Feed&vs=28&utm_medium=.JOBS%20Universe&utm_source=.JOBS%20Sitemap%20Feed-DE
www.kens5.com/news/health/making-insulin-delivery-easier-and-less-painful/410139623
One in ten Texans is diabetic. Most of those who are treating the illness are forced to stick themselves with a needle several times a day. However, there are alternative treatments that are more convenient and less painful.
John Caldwell found out he was diabetic when he was just 16-years-old.
Charles Chavez had been pre-diabetic much of his life, but just recently became insulin-dependent after having his pancreas removed due to cancer. Neither of them have to deal with multiple insulin injections every day.
They each get their insulin in more convenient ways.
"Technology is getting better and better and allows you to live a fuller life, even though there's no cure on the horizon," said diabetes patient John Caldwell.
The technology Caldwell is talking about is the MiniMed 670G from Medtronic, which he has been testing in a clinical trial. It combines precise insulin delivery with continuous glucose monitoring into one system.
"It is constantly monitoring your glucose levels, and it's adjusting basal rates so that people with diabetes can achieve better control more safely with less mental burden," said Mike Hill, vice president of global marketing with Medtronic.
Caldwell said that mental burden can be embarrassing when you're in public.
"You have to stick yourself in the stomach. If you're comfortable enough, you do it in the restaurant booth. That could be a little bit awkward, especially with strangers."
With the MiniMed 670G, you wear it discreetly on your belt or underneath your clothes.
The pump connects to a very small delivery tube which attaches to the skin on your waist, with only one prick needed a week.
"When you see the shield that shows you the algorithm is working and the pump is automatically adjusting insulin based on your glucose levels," Hill said.
Caldwell said that constant monitoring is especially useful at night when he's sleeping.
"My wife Cheryl worries a lot less about me getting sick overnight because my glucose gets too low," said Caldwell.
Charles Chavez is still getting used to checking his glucose.
"On a regular basis, I have to monitor my blood glucose count before each meal," said Chavez, who is now insulin dependent after his pancreas removal.
He still has to inject himself with insulin at night, but the rest of the day, he uses an inhaler called Afrezza.
"What I like most about this insulin is it's a quicker onset of action, and it does not stay in your body too long. There is less risk of hypoglycemia," said endochrinologist Dr. Shahid Aziz.
It's also discreet.
"No one knows I'm taking insulin unless I tell them. Pop it open, drop in the little capsule, close it and inhale it," Chavez said.
"You don't have to go into the restroom or out in the parking lot and take the insulin out and inject. You can just take a small breath, inhale it and you are done," Aziz said.
Afrezza is available now, but not all insurance companies cover it.
The MiniMed 670G will be available this spring, but you can contact Medtronic now to get on their current system, the 630G, and get priority access to the new system for little to no cost.
It was great work, though late, but not late
This job is no worse than tv
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Afrezza ads have been added to Google search
AFREZZA® (insulin human) - Inhalation Powder and Inhaler?
Adwww.afrezza.com/?
Helps control mealtime blood sugar fast. Get prescribing info w/ boxed warning
Safety InformationFind a DoctorHow AFREZZA WorksPrescription Savings Card
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Someone has to use google to do a search for "insulin" or any other search words that Mannkind selected. It is perfectly acceptable to use your competitor's product name as search terms, so Mannkind could pay to have the ad displayed when someone searches for "Novolog" or "Toujeo". Companies in effect bid for placement... the more they are willing to pay per click the more often the ad is shown and the higher it is in the search results. The cost per click can be a few cents to tens of dollars depending on how competitive the bidding for words is. As investors try not to click on adverts if you see them as Mannkind would pay for that. You can see the link address and then copy and paste it into your browser so that Mannkind doesn't get charged for it... and have incorrect data showing more interest in the advert than really represents patient interest.
Afrezza ads have been added to Google search
AFREZZA® (insulin human) - Inhalation Powder and Inhaler?
Adwww.afrezza.com/?
Helps control mealtime blood sugar fast. Get prescribing info w/ boxed warning
Safety InformationFind a DoctorHow AFREZZA WorksPrescription Savings Card
p.s. Reading the Mannkind report at FDA.GOV provides plenty of clues why Afrezza is a failure.
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1, failure or success, not you and I talk about the sure (you and my professional knowledge will not be higher than the fda reviewer)
2, I am an investor, I often take common sense to see the world,
3, on the side effects, whether it is needle insulin, mouth smoking insulin, their chemicals are insulin (of course, early insulin is animal insulin), the only side effect of artificial insulin is low blood sugar, is how the patient's own dose control,
4, on the side effects of the lungs, I have always thought that there is no, smoking people have a lot of longevity
5, failure and success, very interesting topic, born aborted, born after the continuous efforts and success, born flat and faint life have, but only time is the final judge
I bet 2017:
1, February script 2xx
2, March script 3xx
3, April Script 4xx
---------------------
12, November script 11xx
13, December Script 12xx
-------------------------------------------------
In addition,
Mnkd sales are successful: my standard December 31, 2017, the script should be greater than (650-700); the 650 script is the largest sales of Sanofi.
In fact, the current script 300 is only about half of 650,
If the script on December 31, 2017 is lower than (650-700), I will choose time to leave mnkd.
For the reverse dividend, I remain neutral, not good, nor bad, is a number game
But these are only stories. If they are any good they should put them in an FDA report. IMHO.
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1, the story is written by people
2, the fact that the real world
3, I do not know whether your brain is normal, whether there is dementia
thekid2499:
It really is shocking to me how little has been done at this point to market Afrezza and raise awareness. I have a family member who is in the health care system in the Northeast and manages various practices. Today is literally the first time someone has come in to introduce one of his practices to Afrezza. The physicians literally have never heard of it before. The questions the physicians were asking (about spirometry and cancer concerns) are issues that were being discussed 2 years ago here. While the physicians came away impressed and are going to try Afrezza on a few targeted patients, it is crazy to me that this is the first time they have been exposed to Afrezza. The person who gave the presentation from MNKD was the regional sales manager because according to him, his team hasn't been fully built out yet.
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Today, I see good news
sayhey24:
Open Letter to Sales Team
Welcome to Mannkind, I am very excited to have you on our team as our hopes and future are now in your hands. Afrezza is the greatest advance in diabetes treatment since Banting and Best first used insulin in 1922, 95 years ago. You have the ability to dramatically affect the future in diabetes treatment. Research teams are currently working on methods to reduce A1c from the 9+'s to the 7's. With afrezza it should be the norm for patients to be in the 6's, 5's and even 4's. If the patients are not hitting these numbers, don't blame the product as they are either dosing improperly, holding the inhaler upside down, or the patient has other issues in addition to their diabetes.
There is only one thing which can bring down high blood sugar and it is insulin. The best insulin which does this is the insulin secreted from the pancreas, monomer human insulin. No pills, DPP-4 Inhibitor, GLP-1 Agonist, SGLT-2 Inhibitor, or any Analog insulin can do what the healthy pancreas can do. If you can NOT sell afrezza don't blame the product as the product is this exact same insulin which the pancreas secretes. No other product can do what afrezza does and has the pharmakinetics afrezza does which mimics the pancreas. No other Analog is as easy to use as afrezza and there is no carb counting. If sold properly afrezza should dominate the entire diabetes space and should be used by most T1's and T2's including off label for corrections for smokers and those with COPD.
It will not be easy as Big Pharma has been and will continue to throw everything at you to stop you and afrezza. They will convince doctors its too new BUT you know its human insulin and human insulin has been around since the beginning of man. You will also be armed with all the info on FDKP.
BP will point the doctors to the lackluster A1c results from Studies 171 and 175 but you will be armed with the study results from that one doctor in those studies called out by the FDA because he had his patients follow the 90 minute second dose as outlined in the protocol to mimic phase 2 pancreatic release and his results blew away the Insulin Aspart results. You will explain how afrezza mimics the healthy pancreas with phase1 and phase 2 insulin release. You will also explain how import each phase is and that only afrezza can provide that ALL important phase 1 release. You will also be armed with the clamp study results and explain why A1c is really not the best way to treat diabetes but rather time in range.
They will then tell you the current protocol for T2's is to first treat will pills but you will have all the latest studies which show how early insulin intervention can not only stop the progression their patients will see on those pills but in some cases reverse diabetes. For early insulin intervention there is no better choice than afrezza.
Once they run out of every other excuse they will throw the cancer Red Herring at you but since you already know human insulin does not cause cancer you will smile. You will then explain that current diabetics do have a higher rate of cancer and you will be armed with the studies which point to the elongated amount of time the current analogs are in the system as one potential for increased cancer rates. You will explain how fast afrezza is in and out so this may give afrezza a big advantage for not promoting cancer as other analogs may do. You will also have the AspB10 report and explain that no one is quite sure of the long term effects with the analogs and work is just starting to understand if the analogs may be a reason for the higher incidents. Yes, we have been told they are safe but are they really safe for everyone? We know human insulin is safe.
You will be armed with your Abbott Libre and Dexcom and explain titrating using the guide in the starter kit and explain why glucose measuring several times after eating is needed and a second and maybe even a third dose of afrezza may be needed after meals to mimic the pancreas phase 2 release. You can then explain the Libre is fully covered and by lending the new T2 a scanner for several months to do the home measurements while returning every two weeks to collect and review the measurements it is not only the best way to titrate but also fully covered for the patient and profitable for the doctor. It will also guarantee the measurements are available and correct. Ideally Mannkind will have software which can model these results and highlight adjustments which can be made to dosing.
Do your homework, be prepared and be persistent. You have one of the biggest $ markets to sell into and you have the best product. You have the potential to have hundreds of $millions in sales within a few short years. You have never had such a sales opportunity as this. You have real users showing real results on youtube which researchers still can't mimic in their labs with non-insulin approaches. As additional technology products which measure and track real time glucose levels enter the market this should make selling afrezza even easier because nothing can control high blood sugar like afrezza except a healthy pancreas.
www.healthline.com/diabetesmine/afrezza-updates-february-2017
I heard VDEX will do telemedicine for Afrezza Rx
Google for new phone
mango:
• Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism.
—Interesting.
• TOUJEO is a long-acting man-made insulin
—Man-made insulin. Hmm...
• It is not known if TOUJEO is safe and effective in children
—I wonder why that is...
• No clinical studies to establish the cardiovascular safety of TOUJEO have been conducted.
—Of course not.
• TOUJEO SoloStar disposable prefilled pens must never be shared between patients, even if the needle is changed. Pen sharing poses a risk for transmission of blood-borne pathogens.
—Interesting.
• Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between TOUJEO and other insulins, instruct patients to always check the insulin label before each injection.
—No surprise. Interesting nonetheless.
• On a unit to unit basis, TOUJEO has a lower glucose lowering effect than LANTUS [See Clinical Pharmacology (12.2)].
—Interesting.
• In clinical trials, patients who changed to TOUJEO from other basal insulins experienced higher average fasting plasma glucose levels in the first weeks of therapy compared to patients who were changed to LANTUS.
• To minimize the risk of hyperglycemia when initiating TOUJEO monitor glucose daily, titrate TOUJEO according to labeling instructions, and adjust co-administered glucose lowering therapies per standard of care [See Dosage and Administration (2.2, 2.3)].
• Higher doses of TOUJEO were required to achieve similar levels of glucose control compared to LANTUS in clinical trials [see Clinical Studies (14.1)].
—Higher doses to achieve similar outcomes of another man-made product developed by Sanofi? Shocker. Sounds like an inferior product. It is what it is, a genetically modified product— produced by a laboratory strain of Escherichia coli for human consumption.
• Some patients taking insulin therapy, including TOUJEO have experienced erythema, local edema, and pruritus at the site of injection. These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported [See Warnings and Precautions (5.5)].
—Interesting. What do patients experience at the site of inhalation with Afrezza? The sound of a whistle?
• As with all therapeutic proteins, there is potential for immunogenicity.
• In a 6-month study of type 1 diabetes patients, 79% of patients who received TOUJEO once daily were positive for anti-insulin antibodies (AIA) at least once during the study, including 62% that were positive at baseline and 44% of patients who developed anti-drug antibody [i.e., anti-insulin glargine antibody (ADA)] during the study. Eighty percent of the AIA positive patients on TOUJEO with antibody test at baseline, remained AIA positive at month 6.
• In two 6-month studies in type 2 diabetes patients, 25% of patients who received TOUJEO once daily were positive for AIA at least once during the study, including 42% who were positive at baseline and 20% of patients who developed ADA during the study. Ninety percent of the AIA positive patients on TOUJEO with antibody test at baseline, remained AIA positive at month 6.
*** Subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and Himalayan rabbits.
• Insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 50 times the recommended human subcutaneous starting dose of 0.2 Units/kg/day (0.007 mg/kg/day). In rabbits, doses of 0.072 mg/kg/day, which is approximately 10 times the recommended human subcutaneous starting dose of 0.2 Units/kg/day (0.007 mg/kg/day), were administered during organogenesis. The effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or rabbits.
• However, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.
—What is dilation of the cerebral ventricles?
Not something you would want your future child to have to experience. It can lead to fetal ventriculomegaly. Nice 'however' surprise delivery at the end though, Sanofi
• Endogenous insulin is present in human milk;
—Which includes human insulin (Afrezza)
• it is unknown whether insulin glargine is excreted in human milk.
—Will it ever be known? Ok, wishful thinking...
• Because many drugs, including human insulin, are excreted in human milk, caution should be exercised when TOUJEO is administered to a nursing woman.
—Interesting.
• The safety and effectiveness of TOUJEO have not been established in pediatric patients.
—Interesting. Will it ever?
***Carcinogenesis, Mutagenesis, Impairment of Fertility***
• In mice and rats, standard two-year carcinogenicity studies with insulin glargine were performed at doses up to 0.455 mg/kg, which was for the rat approximately 65 times the recommended human subcutaneous starting dose of 0.2 Units/kg/day (0.007 mg/kg/day).
• The findings in female mice were not conclusive due to excessive mortality in all dose groups during the study.
—WTF?!? Interestingly scary to say the least...
• Histiocytomas were found at injection sites in male rats (statistically significant) and male mice (not statistically significant) in acid vehicle containing groups.
—Wow. No suprise.
• These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. The relevance of these findings to humans is unknown.
—Uh huh. Interesting. Will they ever be known to humans?
—Wait...I wonder if Toujeo has a black box warning? Interesting...
www.accessdata.fda.gov/drugsatfda_docs/label/2015/206538lbl.pdf
11/09 / 16cc, there are 1200 doctors
02/01 / 17cc, insurance coverage of 70%
Script 200-300
,,,,,,,
Where is the problem?
The site below gives information on Afrezza coverage in United States.
It is quite long and proves the extent of effort put forth by the Mannkind team in my opinion.
Thank you Mike and Matt.
Try using the below inputs:
formularylookup.com
Input the following: Drug: Afrezza Location (click Pencil): All Location Sort By: Status
Clicking on the "Status" of individual Payer/PBM gives the list of Afrezza alternatives.
Note: Afrezza is the only inhalable and fastest acting diabetic drug listed.
Read more: http://mnkd.proboards.com/thread/7123/afrezza-coverage-growth#ixzz4X73rjs2z
“All-in” on MannKind (MNKD) 1/27/17
*** The following is excerpted from Issue #264 of Nate’s Notes, which was published for subscribers on January 20, 2017, and reflects our opinions of the market, MannKind, and all other stocks mentioned as of that date. ***
The world doesn’t make sense,
so why should I paint pictures that do?
– Pablo Picasso
Still Too Early To Say Much…
First off, I want to acknowledge that the bulk of this month’s issue is once again devoted to discussing MannKind; however, I also want you to know that it is being done on purpose because a) I believe we are at a point in the MannKind story where the tide is either going to turn or it’s not (and so it is worth “pounding the table” sooner rather than later), and b) to be honest, until we see what Trump actually plans to do as President (versus talk about doing as President-elect), I believe it is far more useful to spend time discussing a situation that is at least somewhat “knowable” than to spend a great deal of time reflecting on what a Trump presidency might mean for the stock market as a whole (though rest assured that the topic is also on my mind daily, and it will be discussed in future issues as more information becomes available!).
That being said, as you will notice when you look at the charts of our recommended stocks in this month’s issue, The Trump Rally appears to be alive and well, especially when it comes to our chip stocks, and though it is still too early to know which way the market is going to go once it finally breaks out from the “flatline” pattern it has been tracing out heading into Inauguration day, if it happens to go higher, you are strongly encouraged to look at the move as a reason to add to your positions rather than take profits (beyond the ones that you may need to take in order to allow yourself to sleep more easily at night if certain positions have grown “too large”).
On the flip side, however, as you will see in the Eyebrow Levels table below, the BTK biotech index is continuing to lag the market, and at least a portion of the reason for this is that Trump has spent some time talking about going after the pharmaceutical industry… and so we will need to watch this index especially closely to see how investors end up responding to whatever moves Trump ends up making (or perhaps not making?) as his term gets underway.
Again, my apologies for not spending more time playing “what if” with regards to Trump – for all of the reasons cited below, rest assured that this will likely be the last time I will choose make MannKind the focus on an entire issue… and I hope the fact that virtually all the rest of our positions are “acting well” helps to make up for the fact that I am going out of my way to lay out the case for MannKind one last time before the next chapter of the story gets underway! Cheers!
“All-in” on MannKind
After surging close to 30% in a single day shortly after last month’s issue went to press, MannKind’s stock has pulled back a bit and has spent the past couple of weeks consolidating nicely in the $0.60-$0.70 range… and, while it is true that we would all like to see the stock return to a more reasonable valuation as quickly as possible, a “two steps forward, one step back” chart pattern is not only the more likely path to higher prices (barring a piece of catalytic news, of course), but it is also the sort of price action I would actually prefer to see, as history suggests it will help to set the stage for a longer, more sustained rally as it picks up steam.
Of course, the question is whether it can/will pick up steam… and though we will only know the answer to that question in hindsight, I hope the following set of thoughts gives you some optimism that the tide may finally be turning for us.
First off, with recognition that one of our favorite mantras in the newsletter is “trends often go on for longer than seems reasonable” (so I can’t claim to be all that surprised), the downtrend in MannKind’s stock has gone on for far longer than I ever thought possible (especially given the sorts of results patients are reporting once they’ve learned how to dose Afrezza).
Not only have shareholders suffered through what turned out to be “a lost year (and then some)” thanks to Sanofi’s lack of effort to promote the product, but short sellers have been relentless with their selling… and, as mentioned before, I firmly believe that absent the “extra” 100 million or so shares that have been dumped on the market over the years, the stock probably never would have fallen below $3 or $4.
Of course, at some point (and unless they can force the company into bankruptcy), these short sellers will need to buy back those shares in order to close out their positions, and though they are clearly not doing so in droves just yet, I believe the price action we saw right after last month’s issue went to press may have been a preview of what’s to come. As mentioned before, honest-to-goodness short squeezes are far more rare on Wall Street than folks like to think they are, but when they do happen, they can be spectacular to watch (and, ideally, benefit from!).
And, while I am no way guaranteeing that one will develop around the MannKind situation, based on what I am seeing in the marketplace – along with the emails I have received from subscribers over the past several months – I do believe believe very strongly that virtually all of “the float” (all of the outstanding shares that are not held by management or other insiders, i.e. all of shares that “float” back and forth between regular old investors who buy and sell them on the open market) is now held by investors who are planning to hold their shares “to the bitter end, no matter which way it goes,” as everyone else who didn’t have the stomach for the story has already given up and sold their shares.
While this “ultra-thin float” doesn’t mean much as long as volume remains low and a small number of buyers can get their orders filled by the sellers on the other side of the trade (and vice-versa) without moving the stock much, as we saw a little over a month ago, as soon as a buyer of any size attempts to establish a position, they quickly discover that there isn’t really much stock available for sale unless they are willing to become more aggressive with their bidding.
No, MannKind is hardly a “darling of Wall Street” at this point in time; however, given how the story is unfolding, I believe the odds are improving every day that this “unloved dog of a stock” is on the verge of getting a second look from investors, and given just how large the disconnect has gotten between “current value” and “true value” of company… along with the very large short position… and a sizable cadre of biotech analysts who only have one direction they can go with the stock (from “sell” back to either “hold” or “buy”)… and the aforementioned ultra-thin float (especially when measured against the size of the short position)… it may only take one or two big buyers to finally set the gasoline drenched stack of wood on fire.
Naturally, I’m sure many of you are wondering at this point why I seem to be more optimistic today than I have been in awhile, and the answer is that in addition to the price action itself, I am also very pleased with a number of “news” events that have taken place over the past five weeks – in particular, Matt Pfeffer’s presentation at the JP Morgan Healthcare Conference (JPM) and the hiring of another “high profile” individual from Amgen (in this case, Stuart A. Tross, Ph.D. to head up Human Resources, Information Technology and West Coast Facilities for MannKind as it enters the next stage of its evolution).
Not only is the hiring of Dr. Tross interesting for the simple reason that he is also coming over from Amgen (which is where Mike Castagna came from as well), it provides us with indirect evidence that perhaps things aren’t as bad “behind the scenes” as they sometimes appear to those of us who are trying to figure out what’s going on from this side of the curtain (and, of course, though I am not predicting an Amgen buyout, his arrival has helped to fuel a buzz on social media that he and Mike are there to “get MannKind structured as an Amgen-like entity so that Amgen can hit the ground running once they take over”).
Moving on from such exciting speculation, however, I want to point out that along with the “obvious” factoids that were presented at JPM (see below), I was also struck by two things in particular while listening to Matt’s presentation – not only did he make the presentation with much more confidence and “presence” than he has in during past presentations, even more importantly (in my humble opinion), “the pitch” regarding Afrezza has undergone a significant transformation… and though I haven’t asked him about it yet, I am guessing that all of the “extra” talking points that were made are a direct consequence of the information that was gathered during the first round of having a salesforce on the ground in doctors’ offices figuring out what works and doesn’t work in terms of educating doctors and patients alike about the product (and if this hunch is correct, I believe it bodes well for the next round of the rollout, which is due to get underway early next month).
And, speaking of which, that is one of several items I want to mention from the JPM presentation, namely, we learned that, for a variety of possible reasons, the company is transitioning from using a contract sales force to hiring all of its own sales reps. Not only will this allow the company to offer a more enticing incentive package (via stock options), the fact that they are making the move at all suggests, once again, that things are not as dire on the financial front as they appear on the surface. An unfortunate (but minor and temporary!) consequence of this transition is that Matt hinted that we are once again in a period where there isn’t much going on in terms of sales people trying to generate new prescriptions while the in-house staff gets brought up to speed, and though I know many of you are concerned about “the woeful lack of scripts,” I want to remind you that despite the “dismal” numbers week after week, the stock is actually up over 50% from where it was a month ago… and this is yet another clue to me that anyone who wanted to sell the stock probably already has.
Along with this news about hiring an in-house salesforce, we also learned that MannKind is moving forward with the filings required to sell Afrezza in a number of regions that essentially only require “FDA approval and some paperwork,” namely, Brazil, Canada, Mexico, Australia, MENA (Middle East and North Africa), UAE (United Arab Emirates), and it is also evaluating what would be required to gain approval in “Europe and other regions.” Of course, the company could simply be bluffing, but if they are not, this sort of language once again suggests that they feel much more confident that there will be money around to implement the plan than there might appear to be on first glance by an outsider (or in any one of a handful of persistently bearish blog articles you can read on a weekly basis!).
Not only does the company appear to be moving forward with plans to grow sales of Afrezza in both the U.S. and abroad, it seems to be moving forward with other applications of the Technosphere platform at a slightly more aggressive pace than it was forced to take prior to the settlement with Sanofi (a turn of events that I want to remind you not only changed the financial position of the company by quite a bit, but also made it significantly easier for the company to start talking with other potential partners who may have been reluctant to get involved while Sanofi still had a tentacle involved in the story). Along with its efforts to develop inhalable ephinephrine (efforts that include what the company has called a “successful” meeting with the FDA back in December), the company is moving forward with projects to develop inhalable treprostinil and palonosetron, with an eye towards eventually partnering those products once they are further along in the clinic.
And, speaking of “the clinic,” I believe it is also worth noting that Matt also pointed out at JPM that MannKind is moving forward with plans to conduct pediatric, dosing, and time-in-range clinical trials with Afrezza. In addition, once the commercial(s) have been approved by the FDA (expected in the April time-frame, if I remember correctly), MannKind is planning to rollout its first direct-to-consumer (DTC) TV ads (in very targeted markets at first, mind you). As you might imagine, these clinical trials and TV ads will all require time, personnel, and, money to bring them to fruition… and, once again, these are all things that it would appear on a first glance that MannKind does not have at its disposal, but, reading between the lines, may have “lined up” after all, even if a partnership and/or buy-in (or perhaps even a wildly unexpected – by outsiders – ramp in Afrezza scripts?) that would provide additional capital hasn’t actually been announced/revealed yet.
Moving on to a topic that is less optimistic in nature, as you know, MannKind’s stock is in jeopardy of being “delisted” sometime in mid- to late February if it is not able to get back over $1 and stay there for 10-consecutive trading days; however, to help allay some of the fears that have been expressed to me via email over the past several weeks, I want to remind you of the following things…
First off, even if the stock has not managed to get back over $1 and stay there long enough in time to meet the criteria to avoid delisting, the company can file for another six-month extension (and such petitions are almost always granted), or, alternatively, the company could guarantee the stock price would be over $1 by simply convincing shareholders to approve a reverse split of the stock.
However, I think it is also extremely important to keep in mind that even if the stock does end up getting “delisted,” the only thing that actually changes is that rather being traded on THE Nasdaq trading system, the stock will instead be traded on a “lesser” platform… and while this will undoubtedly cause some investors to steer clear of the stock (and/or cause some institutions to sell their positions based on their by-laws that might require them to only invest in stocks traded on Nasdaq, for example), as mentioned above, I believe everyone who was interested in selling as a result of concern about delisting has already done so.
In addition, and perhaps most importantly, I want to make it clear that your shares would still represent exactly the same thing they represented before the delisting – they would simply be trading on a less prestigious (and, almost certainly, less liquid) “exchange”… and, ironically, I believe it is worth noting that if the stock stopped trading on the main Nasdaq system, it would, in theory, make it even more difficult for the shorts to find shares to cover with IF they ever decide to start covering their position… so, in some ways, it might be worth rooting for delisting; other than that, you will still be a shareholder with the same ownership position and voting rights that you had prior to the delisting (so please don’t let anyone on the interwebs convince you that your shares will instantly become worthless).
Finally, to wrap up what has become a much longer write-up than I was originally planning on putting together for you this month, I want to re-iterate what I said last month, namely, that I think we really are at a point in time where the stock is either going to make it, or it’s not… and, while it will take a bit longer before I would be willing to admit failure and start scaling-out of our position, I do think the odds are very good that IF the story is shaping up the way I think it is, we could see Wall Street returning to the story (i.e. starting to bid up the stock) any time between now and mid-March.
In response to all of the above (and because I believe so very strongly in the underlying value of Afrezza itself), I am making one final “all-in” bet and increasing our position size by 25% in both Portfolios this month… and, barring some bizarre twist, the next trades the newsletter will make in the stock will be sales, either to take some well-deserved profits or to begin the process of scaling-out of our intentionally large positions.
As has been said a number of times, please do not invest more in the story than you a) can afford to lose, and b) can sleep with comfortably at night; however, provided you are still below your threshold on both fronts, I encourage you to step up to the plate and add a few more shares alongside me – “inefficient markets never last forever,” and I really am convinced this is one of the most extreme examples of “the mispricing of assets” I have seen in my 29 years of following the stock market. Stay tuned!
MannKind
As mentioned above (and in last month’s issue as well), I believe we are at a critical juncture in terms of how Wall Street is going to handle the MannKind/Afrezza story going forward… and though I may turn out to be wrong, based on my very strong belief that the company is currently trading for a small fraction of what it is actually worth, I am comfortable pushing the rest of my chips into the pot at this stage of the game and waiting to see what happens. And, along those lines, I will make the “bold” prediction that by the end of this year, we will either be mostly out of our position… or MannKind will have moved onto the list of “core stocks” that we intend to “hold forever.” MNKD remains a very strong buy under $2 and a buy under $5.
Top Picks (for new money this month)
All else being equal (i.e. you already own “pretty much everything” in the newsletter), my top picks for you this month are:
Cirrus Logic (CRUS) – Yep, it’s the same three stocks as Top Picks this month, and for all the same reasons – Cirrus’ stock is bumping right up against its all-time high, and this is always a “bullish” indicator for a stock (at least on a shorter-term basis).
MannKind (MNKD) – As mentioned elsewhere in the newsletter, we’re approaching the “do or die” point for the stock… and so if you have been waiting to buy some, it’s probably time to place your bet.
Skyworks Solutions (SWKS) – not only is the chip sector continuing to act well, it is hard to interpret the recent “gap up” in Skyworks’ stock as anything but “bullish.”
Outstanding Orders
For the reasons discussed above and below, the Model (Aggressive) Portfolio will sell 250 NVDA and purchase 50 (200) Apple, 100 (400) Celgene, 250 (900) First Solar, (300) Illumina, 20,000 (400,000) MannKind, 750 (2,000) PowerShares DB Ag., 700 (3,000) PowerShares DB Cmdties., 200 (500) Qorvo, 100 (500) Skyworks Solutions, and 50 (200) SPDR Gold Trust ETF. We will use the closing prices on Monday, January 23rd, for all transactions.
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www.ktbs.com/story/34287961/inhaled-insulin-shows-promise-as-a-treatment-for-diabetes