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Post by compound26 on May 7, 2015 21:56:13 GMT -5
If Sam and Brian do interview, *their "off label" impact will be tremendous*. You cannot pay enough to have honest and true testimonials such as theirs, I don't care whether you feel the writer is biased or not...it's not like they could "screw up" anything as when you speak the truth you have nothing to fear...the nonsense thrown around about having a great product but if nobody knows about it won't be the case with Afrezza, this is part of the whole process as it continues to gain in acceptance and validation. 100% agree. At this point, publicity is key. It will be especially helpful if this is an in-depth interview so that Sam and Brian can provide as much information as possible to the readers. As long as the paper relays what Sam and Brian say, it will be good publicity for Mannkind, Sanofi and Afrezza.
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Post by compound26 on May 7, 2015 18:42:47 GMT -5
To me, tomorrow's script numbers are more important than the earnings call. At this point, I do not think there is anything significant going to be announced in the call. So the only thing has any real impact on us right now is the scripts trend. Although I do not pay much attention to the result of a particular week, I would hope our growth trajectory remains intact.
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Post by compound26 on May 7, 2015 18:36:13 GMT -5
It appears the author has been following the Mannkind story for quite sometime. Based on his past articles (taken together), he does not sound like a basher of Mannkind or Afrezza.
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Post by compound26 on May 7, 2015 18:33:42 GMT -5
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Post by compound26 on May 7, 2015 18:30:42 GMT -5
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Post by compound26 on May 6, 2015 17:05:39 GMT -5
Thanks, brentie. For easier reference, I am pasting the report here. www.wdbj7.com/news/local/new-inhaled-insulin-takes-the-place-of-mealtime-injections/32845044 New inhaled insulin takes the place of mealtime injections "Patients like it," said Dr. Bailey. "I think it's going to be very popular." Jean Jadhon, jjadhon@wdbj7.com POSTED: 04:28 PM EDT May 06, 2015 UPDATED: 04:40 PM EDT May 06, 2015 ROANOKE, Va. - A new device used to take insulin is now making its way to patients in Roanoke. It's an inhaler that takes the place of mealtime injections many diabetics must give themselves. MannKind Corporation got Food and Drug Administration approval last year for its Afrezza insulin delivery system. At the busy Endocrinology Associates office in Roanoke, the inhaler became available to patients less than a month ago. "Patients like it," said Endocrinologist Dr. D. James Bailey. "I think it's going to be very popular."
The device itself is actually quite small, about the size of a whistle. It allows diabetics to inhale a powdered form of insulin. "This allows people to take their mealtime insulin, the fast acting insulin without having to take an injection," said Dr. Bailey. "They can take it with just a short puff on the delivery system." The powdered form of insulin comes in small cartridges. The patient puts the cartridge in the inhaler device and closes the top which automatically punctures the foil on the cartridge. "All they have to do is remove the little tip (on the inhaler) and then inhale and it goes right in so it doesn't have a propellant," Dr. Bailey said. Dr. Bailey's patients are now just beginning to use Afrezza. So far the feedback is positive. "They like not having to take injections and in fact they're starting to tell their friends who take injections at meals about this," said Dr. Bailey. "So we've had a lot of inquires."
Inhaled insulin is not new. About seven years ago a much larger inhaler by Pfizer pharmaceuticals was introduced but it did not prove successful. This new device from Mannkind Corporation is different. The device itself is much smaller and doctors hope the powdered insulin will be tolerated well by patients. Afrezza is for short term insulin use at meals only and it's not for everyone. People with lung problems such as Chronic Obstructive Pulmonary Disorder (COPD, ) emphysema, asthma and people who smoke won't be able to use it, said Dr. Bailey. • Copyright © 2015, WDBJ7
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Post by compound26 on May 6, 2015 15:31:42 GMT -5
IMHO, there is a good chance that in five years MannKind will be where Regeneron(REGN) is today. Five years ago, Regeneron has a market cap of around 2 billion and today its market cap is around 48 billion. Basically, a 20 times increase.
Today, Mannkind's market is around 2 billion (a little bit less than that at today's closing price). In five years, if Afrezza sells as well as Lantus does today (at around 6 or 7 billion per year), at 25% royalty rate (per Mannkind's management), Mannkind's income will be about 1.5 to 1.75 billion. A 50 billion market cap will put Mannkind at around 30 times P/E on Afrezza alone. Given there will also be additional income that will come from other Technosphere® applications, that valuation won't be unreasonable. And given Afrezza's effectiveness, by the time it is approved and marketed worldwide (i.e., US, EU, Japan, China and rest of the world), a sales matching that of Lantus sales today won't be out of reach.
Interestingly Sanofi owns 30% of Regeneron. Not sure if Sanofi will similarly take some equity interest in Mannkind within the next few years.
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Post by compound26 on May 6, 2015 14:27:30 GMT -5
jpg and seanismorris, both of your arguments made sense to me. However, I do think Sanofi and Mannkind need to release the "2U" whenever they can do it to address the needs of the type 1s. I do not envision Afrezza to get approved by FDA for use by the youth in the near future as Sanofi and Mannkind will need to conduct new clinical studies to support an application like that. That will take years and may not be in their priority lists at all. I understand that, a lot of times, drug companies get into the youth markets just by off-label prescriptions. Especially if the size of the youth market is relatively small compared with the adult market.
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Post by compound26 on May 5, 2015 17:57:07 GMT -5
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Post by compound26 on May 5, 2015 16:41:46 GMT -5
SF: Was that when you changed to the new device? AM: No, I think that a problem during the trials was that some patients took their dose of Afrezza even before starting to eat. The trial protocols called for Afrezza to be dosed "at the beginning of the meal," but sometimes it was taken even before. We need to do additional trials to gain more experience with optimized dosing times. Actual ingestion of food in most meals in the United States except in restaurants takes only about 30 minutes, so I believe that the first Afrezza dose really ought to be taken ten or fifteen minutes after starting to eat. For a longer meal, which is not very common, a second dose might be taken fifty or sixty minutes after starting to eat. For a long feast that lasts for an hour and a half or more, I suggest a third dose be taken at maybe one and a half hours after start. Interestingly I believe the size of all those doses should probably be the same for most patients. Unfortunately the trial protocols called for dosing at the beginning of the meal so we will need to do more trials to be able to gain FDA label approval of optimized dosing. An Exclusive Interview with Al Mann, Founder and CEO, Mannkind Corp. www.diabetesincontrol.com/articles/85-clinical-gems/16894-an-exclusive-interview-with-al-mann-founder-and-ceo-mannkind-corp
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Post by compound26 on May 5, 2015 16:36:53 GMT -5
If that chart depicts the actions of Afrezza and healthy people insulin responses accurately, it appears the best time to take Afrezza is 15 minutes after one starts eating.
This chart confirms what Al Mann has said about the timing of Afrezza (I recall Al Mann said in his speeches that the best time to take Afrezza is 15 minutes after one starts eating).
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Post by compound26 on May 4, 2015 18:38:15 GMT -5
A superiority label will help with EU (and other counties) approval and launch. Even after approval by EU, some European countries have gateway institutions/authorities that do benefit vs cost analysis before recommending drugs to doctors.
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Post by compound26 on Apr 30, 2015 19:07:00 GMT -5
I have not lent out any MNKD shares. So no personal knowledge on this. However, in IB, there is shareholder Yield Enhancement program, through which IB can lend out investors' shares. IB and Investors split the interests received from lending out such shares. Based on my personal experiences, you can choose to participate or quick this program at any time by just checking a box in your account set-up. I assume this (for you to quick your program and thus take back your shares) is routine and not a big deal to the brokers. I would imagine that the short-sells bear the risks that the shares they borrowed may be taken away at any moment by the owners of such shares (through the brokers).
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Post by compound26 on Apr 30, 2015 18:33:06 GMT -5
Yes, agree.
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Post by compound26 on Apr 30, 2015 18:31:52 GMT -5
It could be that SNY has so far only reached out to a very small number of endos, which has resulted the flattening of the growth curve. A Sanofi spokeswoman said that the initial rollout of Afrezza was “ targeted and focused” on building awareness about the product and appropriate usage. It will take time for the drug to demonstrate its potential. MannKind and Sanofi plan to launch a direct-to-consumer campaign this year. www.valuewalk.com/2015/04/mannkinds-afrezza-q1-sales-sanofi/
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