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Post by compound26 on Dec 21, 2015 10:47:18 GMT -5
jpg was at the library today and scoured the magazines for ads, saw only one, in Cooking Light, for December. 20:1 outnumbered in the magazines by other diabetes meds at the small local library I frequent. the Sanofi/MNKD secrecy agreement is so insulting to retail shareholders. Obviously GSCO and the hedge funds knew the whole trajectory and played it like a grand piano, while thousands complained to SEC (which remained silent of course, being the tool of Wall Street). Should we be comforted by the completely linear refill Rx growth? It's very strange, almost controlled. Time will tell. I sure wish that there was an anti-anxiety TS application, and that retail shareholders could be part of Phase I, II, and III. And maybe beyond.... come on, Al, you don't have the f'ing punk to worry about anymore, let's see some action. I can confirm that there is Aferzza ad in the December 2015 issue of the Good Housekeeping. I have a copy of that issue. However, if you did not see the ad, it could be the ad was run regionally. |
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Post by compound26 on Dec 17, 2015 17:23:52 GMT -5
Sax, yes saw that about the 20unit. Funny how some people miss the real news. And listen to the wrong people.Things will get real exciting:-) Thank-you! Rozale probably will be very interested in 20 units as I remember he needs high dosages of Afrezza. And the 20 units will be much cheaper per unit wise. |
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Post by compound26 on Dec 17, 2015 13:02:58 GMT -5
Wonder if shkreli has covered all his shorting positions on MNKD at this moment?
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Post by compound26 on Dec 16, 2015 22:29:04 GMT -5
Unfortunately, it is a catch 22. If Sanofi only begins the trials now in order to show superiority and get a label change, those trials could take two years...or more! During that time, they don't lower the price which will keep insurance companies from adding Afrezza to their formularies. Additionally, Sanofi doesn't advertise because they don't want to waste money until the label is changed and the insurance companies cover and pay more. Can MNKD survive more than a year without significant changes in sales? The trials are important, but the insurance and advertising is more so. Sorry if I'm sounding broken record to some, but I disagree on the need for such long studies. It comes with the caveat that I'm not a medical researcher, but to me it would seem that a study anywhere from 3-6 months would be sufficient to show better control of blood glucose. This is assuming the medical community accepts the concept that lower A1c is a good thing. Obviously if you had to show some other end point such as lower cardiovascular risk, less neuropathy development, etc. you are talking about very long, expensive study. But I would think lower spikes and/or lower A1c without increasing risk of serious hypos would suffice. In another thread I discussed a study being done to look at useful of CGMs in real time dosing... and one of the research directors states that at least one person using Afrezza. This study only has each patient participate for 3 months. Don't see why Afrezza study would need to be longer if it were also based on CGM. mnkd.proboards.com/post/52801Agree. a 6-month trial probably is enough for superiority trial alone (without safety component). See the onset 3 trial below, which is a superiority trial. It lasts only 18 weeks. globenewswire.com/news-release/2015/12/09/793980/0/en/Novo-Nordisk-files-for-regulatory-approval-of-faster-acting-insulin-aspart-in-the-US-for-the-treatment-of-type-1-and-2-diabetes.htmlBagsværd, Denmark, 9 December 2015 - Novo Nordisk today announced the submission of the New Drug Application (NDA) for faster-acting insulin aspart to the US Food and Drug Administration (FDA). Faster-acting insulin aspart is a mealtime insulin for improved control of postprandial glucose excursions and has been developed for the treatment of people with type 1 and type 2 diabetes. The filing of faster-acting insulin aspart is based on the results from the 'onset' clinical trial programme which involved around 2,100 people with type 1 and 2 diabetes. In the onset programme, people treated with faster-acting insulin aspart achieved improvements in postprandial control versus NovoLog® (marketed as NovoRapid® outside the US) and an HbA1c reduction on par with NovoLog®. For people with type 1 diabetes, faster-acting insulin aspart results from the double-blinded onset 1 trial showed statistically significantly greater HbA1c reduction when dosed at mealtime or similar HbA1c reduction when dosed 20 minutes after a meal compared to NovoLog®. Across the onset trials, faster-acting insulin aspart had a safe and well tolerated profile, with the most common adverse event being hypoglycaemia, similar to the levels observed with NovoLog®. "We are happy to be able to file faster-acting insulin aspart for regulatory approval in the US and have the opportunity to address unmet medical needs for people requiring improved blood glucose control around meals," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "Onset 1 shows that faster-acting insulin aspart has the potential to offer improved postprandial glucose and either an additional reduction of HbA1c or added flexibility compared with NovoLog®." Novo Nordisk intends to make faster-acting insulin aspart available in the prefilled delivery device FlexTouch®. About faster-acting insulin aspart Faster-acting insulin aspart is a mealtime insulin for the control of postprandial glucose excursions in type 1 and type 2 diabetes as well as in pump treatment. Faster-acting insulin aspart is insulin aspart (NovoLog®) in a new formulation in which two new excipients have been added to ensure early and fast absorption. About the onset clinical programme The onset programme is a phase 3 clinical programme with faster-acting insulin aspart consisting of four trials encompassing more than 2,100 people with type 1 and type 2 diabetes. The onset 1 trial (1,143 people randomised) - a 26+26-week randomised, double-blinded, basal-bolus, treat-to-target trial investigating faster-acting insulin aspart compared to NovoLog®, both in combination with Levemir® in adults with type 1 diabetes. The results were reported in March and October 2015. The onset 2 trial (689 people randomised) - a 26-week randomised, double-blinded, basal-bolus, treat-to-target trial investigating faster-acting insulin aspart compared to NovoLog®, both in combination with insulin glargine in adults with type 2 diabetes. The results were reported in March 2015. The onset 3 trial (236 people randomised) - an 18-week randomised, open-label, basal bolus vs basal trial confirming superiority (in terms of HbA1c) of mealtime faster-acting insulin aspart in a full basal-bolus regimen versus basal insulin therapy, both in combination with metformin. The results were reported in January 2015. The onset 4 trial (37 people randomised) - a six-week randomised, double-blinded, parallel-group trial confirming pump compatibility and safety of faster-acting insulin aspart and NovoLog® in type 1 diabetes. The results were reported in August 2014. |
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Post by compound26 on Dec 15, 2015 19:42:43 GMT -5
Funny how the teenagers figured out the dosing in a few days all on their own. Kids are always tinkering (in other words, messing around  ). That's why they are better learners than adults on most things technical (and new). And that is the way of thinking and learning that Nassim Taleb has been advocating. |
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Post by compound26 on Dec 15, 2015 19:23:48 GMT -5
Quote: "There is a major shift in the treatment of diabetes....". " More closely mimics the body's natural patterns....also leaves your body quicker, which is the most probably accurate to our human insulin our body will release if you won't a diabetic" " Do not have to calculate how much insulin to inject...." " my sugars being more normal and helps me feel better..." " Made a huge difference in the quality of life...". mssciguy, thanks of posting. This is clearly one of the best TV reports on Afrezza we have seen so far. www.afrezzajustbreathe.com/tv-news-report-on-afrezza/ |
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Post by compound26 on Dec 15, 2015 9:34:37 GMT -5
I don't remember where I read this, but I seem to recall that, in biopharma, the general rule is that the "value" is comparable to 5 years worth of projected profit, (no P/E factor). So - how should we project the next 5 years of profit? We are forced to make assumptions - which is, of course, the case for any such 'valuation'. I would think that for 2016, we could expect to reach 200,000 patients. By the end of 2017, let's say it grows to 1 million... By December of 2018, 2 million... 3 million by 2019... At the end of 5 years, I would (hope) that the patient total is at or near 4 million (globally). Now - using Matt's 25% royalty equivalency, and assuming $5000/year for each patient, we can compute the "5 year projected profit": 2016 - 200K x 5000 x 25% = $250 million. 2017 - 5 x the 2016 number = $1.25 billion 2018 - 2 x the 2017 number = $2.5 billion 2019 - 1.33 x the 2018 number = $3.3 billion 2020 - 2 x the 2018 number = $5 billion Total profit = $9.8 billion... divide that by, oh, let's say with some dilution, 500 million shares = $19.60 PPS I personally think that's low, but that's what I seem to recall reading... somewhere! I like Your post even if I think that numbers are a little bit pumped. We saw from Lantus that reaching 1 Billion sales takes 5 years. Also if We can consider 250 million $ profit from Afrezza next year it means We don't need any cash from now to the eternity. Unfortunately I don't think so. But thinking about a more prudent picture We could have something similar to..... 30 m$ 2016 100 m$ 2017 250 m$ 2018 600 m$ 2019 and 1 Billion$ 2020 This will bring to a 2 Billion$ total profit in 5 years divided 430 million (today) shares We have 4,65$ per share (Today)
Only from Afrezza.
But finally, I am sure We will never need to wait. Afrezza or more then Afrezza will be sold soon It is a new technology and, if succesfull, can be in the market and increasing position for 15-20 years. No one will push Afrezza so high without owning the drug. Just my opinion.
parrerob, agree. That's also my (conservative) assumption of the grown curve for Afrezza. I basically have the same projections as you laid out above. Of course, if we get EU and Japan approval and superiority study done in the near future, the growth curve can be much better. |
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Post by compound26 on Dec 14, 2015 19:14:02 GMT -5
I just read the latest edition of Nate's Notes (dated 11 December, but published today). So the notes were very updated (have the closing price of $1.53 as of last Friday). Nate does not seem to be concerned about the financial situations of Mannkind at all. He averaged down continuously and encouraged his subscribers to average down at this moment (if they are interested). He noted that MNKD's PPS, if without shorts' action, would be around $8-12. So he attributed the current PPS mainly to shorting + tax loss selling. Of course, his discussion is much more detailed than the above. Nate has 28 years' experience investing in biotech and he started to recommend Celgene when it was at $0.44 (split adjusted price) and Celgene is currently at $108 per the notes. So his experience does give me comfort. If you do not subscribe for his newsletter, maybe you can subscribe for one month for $34 to get access to the last few months' notes to see his thoughts on Mannkind. (FYI, I am not affiliated with Nate in any way.  Just a reader of his newsletter.) |
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Post by compound26 on Dec 14, 2015 15:00:48 GMT -5
I don't think they had better information. I think they analyzed the information better and weren't drinking the koolaid. Also, there are no significant well-heeled longs defending the long side and there is smart, agile committed money defending the short side. Trend Agree. Imagine Mannkind has ample cash and is buying back 50 millions share at this level, what will happen? |
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Post by compound26 on Dec 14, 2015 14:34:15 GMT -5
I think most investors are painfully aware of this fact. There may be a lot of disagreement as to why there are so few, but no one is under the illusion that there are thousands of doctors prescribing with the script numbers where they are. Original poster is suggesting a controlled launch as do many others. Drs not willing to prescribe and a controlled launch I am interpreting as two very different things. This may not be a controlled launch by design. But the low awareness of Afrezza among doctors and physicians suggests that at least Sanofi is not spending a big efforts in getting the messages out to the doctors and physicians. In that sense, I think one can still view the launch as a controlled launch. It's kindly of like they arrive under an apple tree, and instead of climbing on the tree to pick the apples one by one, they just lazily throw a couple of stones at the trees and see what happens. I think Sanofi did hold back its efforts in the marketing of Afrezza while they collect, observe and evaluate the feedbacks from users in real life. Therefore, I believe, once they use their full efforts, the scripts will be significantly higher than the current level. |
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Post by compound26 on Dec 14, 2015 14:18:40 GMT -5
I think some investors do not realize how many Dr's are not on board with Afrezza. From laziness to to not knowing long term health problems I believe they are the biggest road block. I think most investors are painfully aware of this fact. There may be a lot of disagreement as to why there are so few, but no one is under the illusion that there are thousands of doctors prescribing with the script numbers where they are. Agree. The small prescribing base (of doctors) + low awareness of Afrezza + high price of Afrezza + Poor insurance coverage (both in terms of tier placement and prior authorization requirements) are the main restraint on script growth. The high price is helped by the Sanofi savings card, but the high price also makes it difficult to improve insurance coverage. I think the small prescribing base (of doctors) is attributable to both low awareness (many doctors have not been educated by Sanofi representatives) and slow adjusting/learning (i.e., unwilling to prescribe (or try new things in general)). However, advertisement will improve awareness and a better label will help on the other three of the four restraints. It now appears a better label is the crucial to the success of Afrezza. |
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Post by compound26 on Dec 14, 2015 13:40:23 GMT -5
Things look rather bad and everyone is depressed so I couldn't resist but to buy back in with a small nibble. This is a good drug. Don't know what the risk reward is but at these prices it is starting to feel like a good gamble (and yes it is a gamble that Sanofi is not dumping them and that they have at least 6 months of cash). JPG, wellcome back. Agree, the stock is way oversold here at this level by tax-selling aggravated by shorting + FUD spread by shots. If Mannk is able to pull in some funds (say, $100-200 million funds, whether from Sanof, a TS partner, debt or equity financing, or a combination of them, or anywhere else) within the next 6-12 months, which I think is more than likely, I think we should at least triple from here (now market cap is $600 million, a triple from here is still less than $2 billion in market cap). |
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Post by compound26 on Dec 14, 2015 13:13:35 GMT -5
Apparently the trial has started (probably sometime in October, Since Sam's message was dated 3 November).
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Post by compound26 on Dec 14, 2015 11:27:35 GMT -5
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Post by compound26 on Dec 14, 2015 10:07:05 GMT -5
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). That's why they are better learners than adults on most things technical (and new). And that is the way of thinking and learning that Nassim Taleb has been advocating.
Just a reader of his newsletter.)