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Post by compound26 on Dec 7, 2015 19:36:29 GMT -5
Fidelity just lowered again to 20.5%! Rate cut in half in about 2 weeks! Any theories why? I say more shares flooded the market to lend out recently. As PPS dropped, the demand for new shorting is not that high. So as a result of supply and demand, interest rate dropped. |
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Post by compound26 on Dec 7, 2015 19:19:38 GMT -5
I'll buy when one or more insiders buys at market price. If the company is working on any deal (say a TS deal that is close to agreement) or any negotiation with a BP, the insiders probably will be prevented from buying even though they know the shares are cheap now. |
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Post by compound26 on Dec 7, 2015 19:17:16 GMT -5
compound26 ... the question isn't whether Afrezza could ultimately become successful if the deal with SNY fell apart. The question is whether MNKD shareholders would still have any equity left at that point... at least that is the question that worries me most. Granted I'd hate to see Afrezza die as a product, but my main concern has to be my own investment. I would expect some dilution, but not significant. |
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Post by compound26 on Dec 7, 2015 19:12:05 GMT -5
compound26 At the current rate of share price disintegration, we will arrive at Goldman's (possibly self-fulfilling) prophecy very soon, $1 I would not compare this to insulin pump. Insulin pumps already exist, how could you compare the novelty of an insulin pump when none existed before to the dreamboat inhaler. The facts of the matter are that other inhalers exist. The Dreamboat might have been very great a few years ago but you get a decay in novelty over time. Even Sanofi has something apparently better in the works with a metered inhaler. We should stop being cheerleaders.... face the reality, sometimes you fall into unrequited love and that drives people into total insanity or war... Discuss pros and cons. It is SNY and MNKD who should have the PR people and investors relations. mssciguy, I do not think the Sanofi inhaler device is better. It is definitely more complex. It allows metered dosage. But whether that is better than fixed dosage, it is debatable. Especially, Afrezza acts like a signal (phase 1 and 2). Think about users in their 70s and 80s and that need to use the meters to get the precise metered dosage each time. That may be considered an inconvenience to them. On the SEC, although I hate the short sellers and manipulators, the possibility is basically zero for SEC to take any meaningful actions to help us. Their action and response time is measured in years not days. And they seldom respond to any pleas of individuals. At least that is my impression after reading: Fooling Some of the People All of the Time, A Long Short (and Now Complete) Story and Confidence Game: How Hedge Fund Manager Bill Ackman Called Wall Street's Bluff. That's why even Al Mann cannot do anything to Martin Shkreli. You will bet Al Mann hate this guy. |
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Post by compound26 on Dec 7, 2015 18:46:57 GMT -5
Let's stay cool. Things are not that bad. The only thing that is bad right now is the PPS. But someone mentioned the other day that Regeneron was down from $26 to $4.6 (or something like that) when it started to partner with Sanofi. Now it is at $546 (as of today). The Afrezza ramp up is slow. But I think if we reach $10-15 million a quarter 12 months from now, then by all means the ramp up is probably 12 months behind the original schedule. That is ok. And whether Sanofi continues to partner with Mannkind (which in all likelihood it will) or Mannkind does it by itself or partner with another BP, the above timeline will be achievable under all these circumstances. Sanofi has already laid the foundation and did the initial marketing. So the existing prescribing doctors will continue to prescribe and the existing user will continue to use. And new users will join the user group gradually. So it appears we will need 2-3 quarters of additional funds, at current rate of cash burn, that will be around $50/60-75/90 million, which may be covered by a TS partnership upfront, debt financing, Sanofi milestone, a second offering, or a combination of them. So there may be some dilution, but I do not expect any significant dilution.As I stated before, we know that pursuant to this article (published in 1995), for Minimed, they started to sell insulin pump in 1985 and in 1990, their annual sales were still at $12.5 million. So five years after launch, Minimed’s annual sales of insulin pump was $12.5 million. Yet, we know that, in the end, Al succeeded in turning insulin pump into a viable option for diabetics. It appears Afrezza’s first year of launch probably will achieve sales of around $10 million, about equal to Minimed’s sales of insulin pump in the sixth year into launch. Quoting the article, “ it's hard to conceive of a more difficult product to develop and market: The pumps must be virtually flawless because their users' health depends on their reliability. But their sales are complicated by their cost--about $4,000 per pump--doctors' skepticism, and the reluctance of diabetics themselves to change their lifestyles.” All the above statements sound familiar? |
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Post by compound26 on Dec 7, 2015 16:49:06 GMT -5
Actually that string of posts makes me nervous. One of the strongest advocates of MNKD is now raising possibility that MNKD will walk from SNY as potentially positive, throwing forth Google connection and making the unsubstantiated claim that tangible insurance improvement has been seen... seems like he is merely posting every hope based long argument from YMB. DBC, I think Nate is just saying these are all possibilities. And I think Nate is also suggesting, even if Sanofi walks away, Mannkind, by itself, or with a new partner, can still make Afrezza a success. I am also of this thinking. The fundamentals (all the signs point to the fact that Afrezza works and works greatly) have not changed. If any change, evidences are accumulating and growing everyday to support this observation.
The only thing changed is the share price, which greatly distorts people's judgment and sentiment.
However, even without much improvement in insurance, with the steady uptick of refills and some modest expansion of the prescribing base, it won't be difficult for Afrezza to sell at least 10-15 million a quarter 12 months from now. That will bring Mannkind much closer to break even (not close to earning a profit, but greatly reduces the quarterly cash burn rate). So we are really talking about 12 months' funds needs from this moment. Existing cash can at least sustain Mannkind to summer/fall of 2016. So we are really talking about two or three quarters' additional cash needs. Probably $50-60 millions. With Al on board, one thing he does have is that he can at least buy some time (or add some flexibility) in terms of the timing of raising additional capital. I.e., if needed, he can increase the Mann Group loan cap at least by a relatively small size (say $20-30 million at one shot) to wait out the downturn of share price and make a second offering or debt financing when the share price stabilize or is in an upward trend. Within the next few quarters, there definitely will be such opportunities for Mannkind to make a second offering or debt financing without significant dilution. It could be any one or more of the following events (which are likely events):
an announcement of a TS partnership with upfront payment,
Sanofi's release the next milestone payment (the development milestone),
Sanofi's demonstration of commitment (enrollment of the safety study) or starting of TV ads,
announcement of EU or Japan filing,
approval of Afrezza is any other coutries (Israel or others),
steady uptick in scripts,
some improvement in insurance, etc.So as stated above, all the signs point to the fact that Afrezza works. So there is no reason that either Mannkind or Sanofi will give up. See my post here for more detailed arguments. And even if Sanofi walks away, Mannkind, by itself, or with a new partner, can still make Afrezza a success. And the current sales of Afrezza is not that disappointing, if compared with Exubura, insulin pump (MiniMed) or Apidra (Sanofi). So both Sanofi and Mannkind have needed experience in overcoming soft launches and historically neither of them gave up under any those circumstances. |
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Post by compound26 on Dec 7, 2015 16:07:02 GMT -5
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Post by compound26 on Dec 7, 2015 12:20:13 GMT -5
Note that Sam (Sam on Tudiabetes.org, not Sam Finta) uses less than one box in one month (he says one box will last 1.5 months for him). That is atypical. Most Afrezza users use more than that. Sam Finta uses about two boxes a month and I think at some time Laureen indicated that she uses 9 boxes for three months. In another tweet she mentioned she got a refill for 90 days for 7 boxes. I would roughly estimate that generally a user will probably need two boxes of Afrezza per months. That would reasonable as a 90 cartridge only gives you one cartridge for each meal. Since you will naturally need additional units for snacks and follow-up doses, two boxes per month would seem to be the right (average) number. In that case, the average cost will be much higher (than $159 as indicated by Sam on Tudiabetes.org), if not covered by insurance. This is because the Sanofi savings card is limited to one box per prescription/refill. So if you need two boxes per month, without insurance, the cost will be $380+ (say if you get two boxes of 90 x 4Us at Costco without insurance) or somewhere around $400. |
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Post by compound26 on Dec 5, 2015 12:14:06 GMT -5
Got over 1000 page views yesterday globally. It is so fascinating to see all of the countries and browsers out there, interest in Mannkind is GLOBAL prntscr.com/9anf6z (Note to Sanofi: It's time to give the people what they want). compound26 I'll launch more pages including your emax health (just a copy and paste with a couple of images) -- Monday though. I've noticed that the Europeans seem to mostly browse M-F .. the US is more addicted to internet than elsewhere generally, it seems Please let me know if you have anything else. I am very fast with blogspot mssciguy, again nice job! In addition to the emax health article, consider also posting the Cleveland clinic article and the ProMedica news reports. Note in the ProMedica news reports, the harmacist for ProMedica commented: But Rocha says so far, so good for the ProMedica diabetic patients that she's worked with. "I don't think I've heard any negative feedback from patients that have started it and that were able to successfully go on it with their insurance company approving it," she said. And in the Cleveland clinic article, they summarized the benefits of Afrezza as follows: It decreases risk for hypoglycemia. The onset time is 12 to 15 minutes and it is totally out of your system within 180 minutes. It is painless, convenient and effective. Once inhaled, the insulin gets released into the body through your lungs and released into tiny airways that help move the insulin into the bloodstream quickly. Color coding makes the dosages easy to identify. The color coding of the blisters are blue for four units, green for eight units and yellow for 12 units of insulin. This color coding decreases the possibility of errors. The blister and the inhaling device are small and compact. Both can easily fit into a small purse or pant pocket. The inhaling device is included with the monthly prescription. The device is changed every two weeks and needs no special care. Simply place the cap back on after use. It is easy to use. To properly use the inhaling unit, you just place the prescribed blister containing a powder form of insulin into the device. Breathe out, place the device in your mouth and take in a deep breath slowly over the course of three to five seconds. Then breathe normally. links to the articles can be found here: www.afrezzajustbreathe.com/afrezza-introductory-materials-made-by-physicians/ |
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Post by compound26 on Dec 5, 2015 12:03:13 GMT -5
ProMedica utilizes insulin inhaler for some diabetic patients
www.wtol.com/story/30662215/promedica-utilizes-insulin-inhaler-for-some-diabetic-patients#.VmIjccZF6bM.twitterPosted: Dec 03, 2015 3:07 PM CST; Updated: Dec 03, 2015 5:24 PM CST By Cristina Mutchler (WTOL) -Many diabetics receive insulin through an injection, but there may be another option available. Some medical experts are recommending inhaling insulin for diabetic candidates who qualify. Currently, there's only one insulin inhaler on the market, and it's called Afrezza. "It is new; it was released over a year ago, and it is a small inhaler. It is a rapid-acting insulin," said Rachel Rocha, pharmacist for ProMedica. "It is to be taken before every meal, and if you're a Type 1 diabetic, you still need to be getting a long-acting insulin, which would have to come still from an injection." Rocha says both types of diabetic patients may be able to benefit from the inhaler, with some restrictions. The compact device contains inserted, pre-measured, rapid-acting insulin that is used before meals. An insulin powder is breathed into the lungs and enters the bloodstream through the vessels. Many diabetic patients can utilize it, including those who may be more comfortable with an inhaler rather than an injection. "If someone is needle-phobic, I think this is a good option, if we could just get their dose to be appropriate to fit this model," said Rocha. Afrezza comes in different strengths and dosages, but it’s not approved for children. "Some common side effects of Afrezza are low blood sugar, which is across the board with all insulin, and then also a dry cough or a productive cough, also some throat pain, or headache," said Rocha. Smokers or those with lung disease, such as asthma or COPD should not use inhaled insulin. In fact, in order to begin utilizing it, patients first need to complete a lung function test. If the results are poor, they are not considered a candidate for Afrezza. But Rocha says so far, so good for the ProMedica diabetic patients that she's worked with.
"I don't think I've heard any negative feedback from patients that have started it and that were able to successfully go on it with their insurance company approving it," she said.
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Post by compound26 on Dec 4, 2015 22:54:52 GMT -5
Sanofi's inhalable insulin Afrezza new hope for diabetes treatmentwww.emaxhealth.com/1/pfizers-inhalable-insulin-afrezza-new-hope-diabetes-treatmentBy Susanna Sisson 2015-11-19 19:00 Early in 2015, it was announced that the world’s first viable, inhalable form of insulin, Afrezza, was about to hit the market. Another similar drug, Exubera, marketed by Pfizer in 2005, failed in marketplace showing as well as efficacy due to the enormous size of the delivery device, and was taken off the market within two years. According to the manufacturer, Mannkind who teamed up with French pharmaceutical giant Sanofi to produce Afrezza, the drug has many benefits over current available hyperglycemic drug options. Pros of Afrezza• Approved for both Type 1 and 2 diabetics.
• No needles – Afrezza is powdered insulin that dissolves immediately when inhaled into the lungs, and is then quickly dumped into the bloodstream to start working. The drug is delivered via a tiny inhaler device rather than the standard insulin pen or pump that is meant to be disposed of after 15 days. • Convenient – The device, called the Dreamboat, is about the size of a human finger thus easy to carry in purse or pocket. Afrezza is available as 4 unit and 8 unit single-use cartridges. Three cartridges are contained in a single cavity of a blister strip. Each card contains 5 blister strips separated by perforations for a total of 15 cartridges. Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package). The perforation allows users to remove a single strip containing 3 cartridges, which can be carried in a pocket or a purse. The company is planning new sizes of the drug in 9 and 12 unit cartridges.[4] • Rapid acting – Afrezza enters the bloodstream faster than Humalog insulin and has a shorter half-life so it is able to counteract the peak blood level spike of glucose from carbs and is out of the system rapidly enough to prevent lingering low blood sugar levels. • Reduces hypoglycemic episodes – While doctors and proponents of Afrezza say it does reduce incidence of post-prandial (post meal) episodes of low blood sugar, the FDA would not allow that to be part of the product usage labeling. • Tighter control - Afrezza can be used after a larger meal to lower blood sugar and bring down highs quickly without the risk of stacking insulin. • Less weight gain – While some diabetes medications cause weight gain, Afrezza does not appear to have that side effect. • No munchies – with better blood sugar control, there are fewer episodes of blood sugar drop and the hunger that goes with which may also account for less weight gain. Cons of Afrezza• Not a stand-alone insulin therapy and does not replace other hyperglycemic drugs such as injectable insulin. Afrezza is intended for pre-prandial use and post-prandial spikes. • Contraindicated for patients with any lung disorder such as COPD or asthma or for smokers. • Not approved for pediatric patients, yet, but the company is seeking FDA approval for pediatric use. • Not covered by some insurance plans so be sure to check your policy. Afrezza is fairly also cost effective and comparable to injectable insulin. Walgreen quoted a cost of $334 out-of-pocket cash price for a box of 30 4-unit cartridges or 60 of the 8-unit cartridges. Insurance companies that currently pay 50% of patient’s insulin costs also cover Afrezza, so, the price would be $130.80 for a box of 60 of the 4-units that should last a month. That is comparable to current insulin prices – and even potentially a bit less than what many pay for a month's worth of Humalog or Novolog. Resources: 1. www.mannkindcorp.com/2. www.webmd.com/diabetes/news/20140630/inhaled-insulin-afrezza?page=33. www.healthline.com/diabetesmine/welcome-afrezza-inhaled-insulin-gets-real#44. www.healthline.com/diabetesmine/holding-our-breath-for-inhaled-insulin-afrezzaIMPORTANT SAFETY INFORMATION FOR AFREZZA® (INSULIN HUMAN) INHALATION POWDER WARNING: RISK OF SUDDEN LUNG PROBLEMS (BRONCHOSPASM) IN PATIENTS WITH LONG-TERM (CHRONIC) LUNG DISEASE Sudden lung problems (acute bronchospasm) have been seen in patients with asthma and COPD (chronic obstructive pulmonary disease) using Afrezza®. Afrezza® is not to be used in patients with long-term lung disease such as asthma or COPD.
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Post by compound26 on Dec 4, 2015 15:02:12 GMT -5
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Post by compound26 on Dec 4, 2015 14:57:00 GMT -5
I also confirmed it here. If you choose to not trust my information that is your problem. I do not post unreliable information. |
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Post by compound26 on Dec 3, 2015 17:39:42 GMT -5
Can you then switch insurance to get a better coverage for 2016? Or is that not a practical option for you? And how many boxes you are using in one month and 90 days? lookup.decisionresourcesgroup.com/And if you are able to switch insurance, go ahead switch and then write a letter to UHC informing them that you have to switch insurance because they do not cover Afrezza. With enough people switching, the insurance companies will have to wake up and beef up their coverage for Afrezza. |
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Post by compound26 on Dec 3, 2015 17:13:52 GMT -5
Remember how Shkreli got involved by interfering with the FDA, which led to the second CRL and another half $billion in development costs?
Perhaps Sanofi is prudent and keeps a lid on things because they know that not only shorting hedge fund managers but many direct pharmaceutical competitors would also try to interfere if they were to know Sanofi's game plan... MN, I do not know if your comment was directed to me, but just in case. When I say I would like a bit more clarity I do not mean from Sanofi. It would be nice to know what they are planning, but I understand their concerns and why they do not feel compelled to share anything. On the other hand, I do feel like Mannkind could lift a huge weight from our shoulders by clarifying a bit more what their financial situation is, and how if any it is affecting future development of other TS apps. I feel the longer they go without saying anything the longer and more ingrained the perception that they are in serious trouble will dominate the events. Personally, I am now thinking 2 to 4 more years before we see MNKD really do well in our portfolios. My concern is how they are going to cope financially and what will need to be sacrifice if any. I am sure there is a plan, I just would like them to, at least, give us some pointers. As long as Sanofi has a strong commitment, Mannkind will find ways to finance the gap (from now till Afrezza ramp up). Sanofi buy in (a minority interest) or provides a loan are certainly among many of the options there. I agree with Stevil that "SNY will dump obscene money into making sure Afrezza is successful if they choose to stick with it. SNY needs something big right now, and while I don't think they're quite desperate, they probably aren't far off. SNY needs something big to stay a market leader." Their PPS has dropped about 15% in the last month and they now do not have a product to maintain their market leader position in the insulin market. I do not think they can count on Tuojeo to be able to fend off Tresiba. And now all kinds of evidence suggesting that Sanofi has a strong commitment. The 500 people trial where Afrezza is used (which trial won't end until 2017), the three post-marketing trials being completed/recruiting, with the pediatric trial requiring CGM (hinting of collecting of additional data for use by Sanofi), the November Vegas training of reps people rumored about, continuing print media DTC (latest is the December issue of Good Housekeeping, which supposedly reaches an audience of 24 million each month), recent start of mass direct mailing in select markets (CA, Florida, etc.), and now this advisory board meeting with early adopters of Afrezza (and probably also certain prescribing physicians, as we know that Dr. Steven Edelman prescribes Afrezza). |
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