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Post by mnholdem on Sept 1, 2018 16:17:17 GMT -5
Primatine Mist was indicated for asthma before the FDA banned all aerosols using the old propellant. TreT is for indicated for PAH not for asthma. I don’t see to two in conflict with each other or how TreT poses a threat.
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Post by mnholdem on Aug 30, 2018 14:57:56 GMT -5
TEVA recently got FDA approval on generic Epi pen, didn’t they? |
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Post by mnholdem on Aug 30, 2018 14:52:39 GMT -5
Remember that the PR likely won’t come until after the interest payment and only if the Deerfield Agreement gets amended. Cash payment means no PR until the next earnings call.
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Post by mnholdem on Aug 30, 2018 7:57:22 GMT -5
It appears that MannKind’s new CMO is earning his pay.
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Post by mnholdem on Aug 30, 2018 7:52:58 GMT -5
Correct. I should have mentioned the inclusion of more recent data.
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Post by mnholdem on Aug 29, 2018 21:45:11 GMT -5
www.thediabetescouncil.com/inhaled-insulin-afrezza-being-marketed-to-those-with-type-1/Excerpt: The main benefit other than a needle free introduction into the body, of Afrezza is that it works in five minutes after it is inhaled. It has been shown to shut down the hepatic glucose production, which means the blood glucose in the body does not go up first then come down as it typically does with regular injectable insulin.
There is Still Work to Be Done
Before Afrezza can become a hit with many in the diabetic community there is still plenty of work to be done. Doctors as well as insurance companies and patients need to be educated about the inhaled insulin.
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Post by mnholdem on Aug 29, 2018 20:03:43 GMT -5
They have presented at both of these annual events before. They need to provide an agenda that updates on progress in Brazil with Biomm, progress with Cipla in India and what Tanner is doing to provide distribution of Afrezza and the pediatric study. An estimate of when shipments to these counties is essentail. Mike also needs to have a compelling story for TrepT. Anything else will have the analysts and investors heading for a potty break before Mike gets to the podium. They have heard the Afrezza story before and should have heard about STAT by now. It's time to shine or quit exposing the fact that progress has been hellaciously slow. If there is ever a time to provide "clarity" it is before the presentations. C'mon Mike you can do this! An accurate assessment of the market share of Technosphere API in the pipeline would be good, but the CEO needs to present specific and compelling reasons why MannKind believes that Afrezza will become the Standard of Care among Type 1 mealtime insulins and for treatment of early-stage Type 2 diabetes. One of the CEO's objectives is to convince several analysts to publish Buy recommendations for MNKD stock with significantly higher 1-Yr price targets. Repeating data, charts and graphs will not be sufficient. CEO Castagna needs to succinctly communicate his vision for MannKind Corporation. |
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Post by mnholdem on Aug 29, 2018 19:46:19 GMT -5
Certainly the John E. Anderson publication in The Journal of Family Practice qualifies since it presents Afrezza and recent data supporting inhaled prandial insulin. I get the gist of your post, though, in light of Dr. Kendall's recent comments that several publications will be released in the coming months. In September, two active clinical studies are scheduled to complete their primary outcomes: the Baltimore study on introducing Afrezza in early diabetes and the Afrezza-OneDrop study. Both have primary outcomes which measure reduction of A1c levels. It's an antiquated measurement, but one that's still accepted by the medical community. Publication dates for these two studies should be in the October/November timeframe, IMO. Finally, there is Dr Kendall's presentation at the EASD 2018 annual meetings. Publication of Kendall's findings likely cannot be published before the Oct 2-5 meetings in Germany and, I believe, will involve CT SCAN stats mined from data of past clinical studies. I think these findings will be significant and may even impact the FDA-mandated post-market lung safety study. Kendall's October presentation will be the 2nd publication mined from past studies, what MannKind's CMO labeled as 'veins of gold'.  |
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Post by mnholdem on Aug 29, 2018 16:57:12 GMT -5
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Post by mnholdem on Aug 28, 2018 21:04:02 GMT -5
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Post by mnholdem on Aug 26, 2018 21:53:27 GMT -5
Matt lowballed by estimating land and building value only (interesting that he specifically uses the term “liquidation scenario”)!and stating, in effect, why would a company buy a plant where they cannot manufacture their other drugs. The answer is obvious: the plant would only be used to manufacture Afrezza until other plant(s) could be built globally. One other factor Matt overlooks is the manufacturing licensing fee.
The value of Danbury is not just building and land. Brazil and China could be supplied with Afrezza immediately and expand finish fill lines if needed. Incidentally, the Sanofi agreement included a manufacturing license. Look it up.
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Post by mnholdem on Aug 26, 2018 7:02:40 GMT -5
The Right Recipe for Achieving PPG Control: To Inhale or Inject?
Medscape Education Diabetes & Endocrinology, August 24, 2018
This interactive symposium will guide participants through a comprehensive diabetes management plan, including a detailed look at how inhaled insulin can be used to improve patient outcomes
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Post by mnholdem on Aug 26, 2018 6:30:49 GMT -5
One idea being batted around among my circle of friends is to sell the Danbury plant to Amphastar for roughly $200 million cash as part of a China deal. MannKind could either lease the plant or give AMPH manufacturing rights which would eventually expand into manufacturing plants in China and Europe. Amphastar has first rights to China sales as part of a renegotiated purchase agreement with MannKind for the insulin used to manufacture Afrezza and it has experience in manufacturing inhalable medications. They’ve recently announced expansion plans for China. Source: ir.amphastar.com/news-releases/news-release-details/amphastar-announces-expansion-amphastar-nanjing-pharmaceuticalsAmphastar Pharmaceuticals, Inc., headquartered in Rancho Cucamonga, California, established in 1996, is a recognized specialty pharmaceutical company that uses state-of-the-art, cGMP compliant facilities to develop, manufacture, and market injectable and inhalation products. In addition to the Corporate Headquarters, Amphastar has five manufacturing facilities located in the United States, China and Europe along with a state-of-the-art New Drug Research Center. |
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Post by mnholdem on Aug 25, 2018 11:33:45 GMT -5
Great rebuttal, tinkerbell. I’m not suggesting that Castagna is not keeping himself busy, but I would expect a CEO, as the face of the company, to be more public. While it’s important that he build a vision and plan for his executives, my concern is that he’s micromanaging.
I guess that I expected the CEO to be actively promoting the company to more than shareholders and investor conferences.
For example, the new CMO has been assertive, calling current diabetes treatments “antiquated and barbaric”. Now that he’s CEO, I don’t see that type of assertiveness from Mike.
I would expect a CEO to be heavily involved in negotiations so perhaps that’s where much of his time is being spent and why public promotion of the company’s technology, potential and challenges has taken a back seat.
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Post by mnholdem on Aug 24, 2018 21:12:38 GMT -5
I do have a difficult time explaining how MannKind’s former Chief Commercial Officer, who was selected by the Board of Directors for a CEO position in spite of his lackluster results, is still struggling with the effective marketing of Afrezza.
I happen to agree with CEO Castagna that scripts should be in tens of thousands, but I have yet to see any sign whatsoever that he can deliver market acceptance. He may have sold himself to the majority owners and the BoD but he has not sold himself to me or a majority of shareholders.
I’m not prepared to give Castagna full credit for the Kendall hiring either. Castagna was the closing pitcher on that win.
Was he so arrogant that he believed his marketing skills & ideas alone were sufficient to get the job done (via his hiring of specialists) and only now after nearly three years of getting control of Afrezza back from Sanofi he’s putting together a qualified marketing team?
Perhaps he blamed his lack of success on the previous CEO. But now, as CEO, all failure and success must be laid on his shoulders. I believe Afrezza will eventually become successful because of the Kendall hiring. The new marketing team is an unknown at this point. But Castagna, unfortunately, still remains a big unknown to shareholders and to Wall Street.
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