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Post by lakers on Mar 7, 2016 14:16:52 GMT -5
I heard some unconfirmed chattering re: due to Al Mann death Mnkd will get debt forgiveness from Al Mann Group through a will or estate planning. I forgot how much Mnkd owed the Mann group.
The Pps increase may portend decent Sny settlement and/or regional partnerships.
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Post by lakers on Mar 7, 2016 3:05:13 GMT -5
Omeros CEO said: “And we don’t have a formal life science or biotech initiative like Texas, Wisconsin, Florida and Massachusetts where multi-billion dollar biotech initiatives contribute to the ability to establish companies in those states,” he added. “At Omeros, we are trying to support that sort of initiative by putting together a fund, in cooperation with Life Science Discovery Fund and Vulcan to use our profits to spin out biotech startups.” www.emikeflynn.com/blog/286/omeros-juno-restore-
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Post by lakers on Mar 4, 2016 16:39:02 GMT -5
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Post by lakers on Feb 27, 2016 17:53:55 GMT -5
VDEX must be very deep pocketed. It must be funded by big players. "Beginning with a single office in New Jersey and two more to follow closely behind, we have ambitions to introduce our model of diabetes care throughout the United States. Please check back to see new locations as they are added across the country." Lakers, What makes you believe that they need to have deep pockets, well beyond the capacity of some MNKD investors. They utilize the infrastructure of existing, smaller care centre companies, have some few equipment and an endo on telephone standby. Does not sound expensive to me. Adding centers means to do more contracts. This is the same concept as store within store, Apple, Samsung stores within Thousands of Best Buy stores nationwide. Apple, Samsung paid a lot to do just that. Small player can't afford that. Matt's slide mentioned large scale deployment.
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Post by lakers on Feb 27, 2016 17:39:02 GMT -5
Could it be a JV startup funded by Verily and DEXcom? It fits their treatment vision. No.. its made clear in one of the threads that this idea came in from Mannkind investors...No big player involvement VDEX must be very deep pocketed. It must be funded by big players. "Beginning with a single office in New Jersey and two more to follow closely behind, we have ambitions to introduce our model of diabetes care throughout the United States. Please check back to see new locations as they are added across the country."
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Post by lakers on Feb 27, 2016 17:32:47 GMT -5
No .. its not something google would get into..treatment centers? Could it be a JV startup funded by Verily and DEXcom? It fits their treatment vision. The VDEX doesn't sound like a single meaningful word. It seems a joint entity?
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Post by lakers on Feb 27, 2016 17:26:50 GMT -5
Google Life Sciences (Verily) earlier this week announced a partnership with Sanofi, maker of an insulin inhaler and a slew of other products for people with diabetes. Google is also working with Johnson & Johnson on surgical robots, Biogen on potential treatments for multiple sclerosis and Novartis and Dexcom on diabetes-related projects. www.npr.org/sections/health-shots/2015/09/06/437570402/why-google-is-going-all-in-on-diabetesCheck out the VDEX Symbol with Black V in circle (contact lense) and DEX in Blue - 2 different designs. Verily symbol is a single underlined "V". DEXcom symbol is "DEXCOM". www.vdexdiabetes.comAlfred E. Mann, 1925 - 2016 Vdex Diabetes [Real Time Diabetes Control] is dedicated to the memory of Alfred Mann who was responsible for the betterment of so many lives both diabetic and otherwise. Al lived his life in a manner that serves as a model to us all. His focus, both personally and professionally, was on solving problems for others. We at Vdex strive humbly to carry on his legacy in the field of diabetes. Whatever success we enjoy will forever rest upon the foundation created by Al Mann. Beginning with a single office in New Jersey and two more to follow closely behind, we have ambitions to introduce our model of diabetes care throughout the United States. Please check back to see new locations as they are added across the country. Selecting a pin below will enable you to see website and direction information for each VDex location.
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Post by lakers on Feb 27, 2016 2:52:33 GMT -5
Hope there will finally be a full 60min, 20/20 story about Al's contributions to Mankind, how he made a dent in the universe. Ironically, it may take his passing for Afrezza to finally be known nationally. As most of you I celebrate his meaningful life and great contribution to Mankind. May Al's spirit guide Matt and the BoD to realize his vision.
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Post by lakers on Feb 23, 2016 17:16:14 GMT -5
www.keyc.com/story/31295473/sanofi-us-to-return-auvi-q-epinephrine-injection-usp-rights-to-kaloBRIDGEWATER, N.J., Feb. 23, 2016 /PRNewswire/ -- Sanofi announced today that the license and development agreement between Sanofi and kaléo, formerly Intelliject Inc., the developer of Auvi-Q® (epinephrine injection, USP), will terminate later this year. At that time, all U.S. and Canadian rights will be returned to kaléo. Sanofi is in discussions with kaléo on these terms and for an orderly transition plan. Kaléo will evaluate timing and options for bringing Auvi-Q back to market. The decision to return rights for Auvi-Q aligns with Sanofi's ongoing transformation to focus on critical therapeutic areas in its five global business units: Diabetes & Cardiovascular, General Medicines & Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi US will complete the return and reimbursement process associated with the October 28, 2015, voluntary nationwide recall of Auvi-Q. For more information on the recall, please visit www.Auvi-Q.com. Indication Auvi-Q® (epinephrine injection, USP) is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions. Important Safety Information Auvi-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after use. Each Auvi-Q contains a single dose of epinephrine. Auvi-Q should only be injected into your outer thigh. DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY. If you accidentally inject Auvi-Q into any other part of your body, seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms. Sanofi abandoning Auvi-Q after dosage problems led to total recallBy Dan Stanton+, 23-Feb-2016 Sanofi is poised to terminate its Auvi-Q marketing deal says PDL Biopharma, citing manufacturing issues last year which led to a complete recall of the epinephrine injection product. www.in-pharmatechnologist.com/Processing/Sanofi-abandoning-Auvi-Q-after-dosage-problems-led-to-total-recall12) Mannkind 3 Internal Technosphere Drugs In Development 2 Will Be Partnered & 1 Held By Mannkind 13) Epi Pen New Inhaled Drug Development Will Be Held By Mannkind & Has Huge Potential14) Technopshere Future Drug Candidates Regulatory Path Will Be Quick Only Needing Bio-equivalency TrialsFormer Mylan CMO, current Mnkd CMO Ray said, "The last candidate I’d like to speak about is Epinephrine for the acute treatment of anaphylaxis. In the U.S. alone, Epinephrine used in anaphylaxis represents a market over $1 billion. Epinephrine is used as a drug of choice with initial treatment of suspected anaphylactic reactions. Patients with known allergies are often asked to carry Epinephrine auto injectors. These drug device auto injectors tend to be large and inconvenient to carry around. They also involve an invasive procedure that is to say an injection into the lateral thigh. This has led to episodes where patients have postponed this injection leading to an adverse clinical outcome. We believe that the oral inhalation route will provide more than adequate levels of Epinephrine. In addition, this noninvasive step has the potential to prevent untoward outcomes secondary to delaying treatment for fear of an injection. Epinephrine is in the early technical assessment phase. Preclinical work is expected to begin in the second quarter of this year followed by clinical trials beginning in the first quarter of 2017.For those that may have questions whether an inhaled medication is suitable for use during the initial phase of an anaphylactic reaction, patients typically know when they are having the reaction. This is well before the full physiologic effects of anaphylaxis become apparent. This is when they typically take an antihistamine, for example, Benadryl because they do not want to inject themselves thinking that the Benadryl will help. Well, it doesn’t. This product will now offer them a noninvasive option. Clearly, there is a very substantial U.S. and global market already for Epinephrine including millions of pediatric and young adult patients. The market is dominated by one player [Mylan]. We will be pursuing partners in which to penetrate this established market with a product that addresses a significant unmet medical need." Read more: mnkd.proboards.com/thread/5129/mnkd-investors-cc-slides-16#ixzz411J1bXsHMylan Confirms Availability of EpiPen® (epinephrine injection) Auto-Injector for U.S. Patients Affected by Sanofi's Auvi-Q® (epinephrine injection, USP) Recall www.prnewswire.com/news-releases/mylan-confirms-availability-of-epipen-epinephrine-injection-auto-injector-for-us-patients-affected-by-sanofis-auvi-q-epinephrine-injection-usp-recall-300168925.htmlAccording to Sanofi, Auvi-Q® products have been found to potentially have inaccurate dosage delivery. If a patient experiencing a serious allergic reaction did not receive the intended dose, there could be significant health consequences. [ Imagine Mnkd partners with Mylan for inhaled Epinephrine]
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Post by lakers on Feb 23, 2016 17:07:38 GMT -5
Form 8-K for MANNKIND CORP
23-Feb-2016
Change in Directors or Principal Officers
Item 5.02 Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(b) On February 17, 2016, Alfred E. Mann notified us of his resignation from our Board of Directors, effective immediately. We issued a press release announcing the resignation described above on February 19, 2016.
(e) Mr. Mann continues to serve as an employee of MannKind Corporation and receives salary at the annual rate of $240,000.
On February 18, 2016, we granted the following stock option to Matthew J. Pfeffer, our chief executive officer, in connection with his promotion to such office on January 10, 2016:
Exercise Price
Name Options Per Share
Matthew J. Pfeffer 604,267 (1) $ 0.92
(1) Twenty-five percent of the shares subject to the option vest one year following the vesting commencement date of January 1, 2016, and thereafter the remaining shares subject to the option vest in equal monthly installments over the following 36 months.
The foregoing stock option was granted under our 2013 Equity Incentive Plan (the "Plan") and is evidenced by a Stock Option Grant Notice and Option Agreement (collectively, the "Grant Documents"), which, together with the Plan, set forth the terms and conditions of the stock option. The foregoing is only a brief description of the material terms of the stock option, does not purport to be complete and is qualified in its entirety by reference to the Plan, attached as Exhibit 99.1 to our Registration Statement on Form S-8 (File No. 333-188790) filed with the Securities and Exchange Commission on May 23, 2013, and the forms of Grant Documents under the Plan, which are attached as Exhibit 99.2 to our Registration Statement on Form S-8 (File No. 333-188790) filed with the Securities and Exchange Commission on May 23, 2013.
[Matt Has Great Incentive to Get The Price Up!]
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Post by lakers on Feb 23, 2016 15:23:08 GMT -5
12) Mannkind 3 Internal Technosphere Drugs In Development 2 Will Be Partnered & 1 Held By Mannkind 13) Epi Pen New Inhaled Drug Development Will Be Held By Mannkind & Has Huge Potential
14) Technopshere Future Drug Candidates Regulatory Path Will Be Quick Only Needing Bio-equivalency TrialsFormer Mylan CMO Ray said, "The last candidate I’d like to speak about is Epinephrine for the acute treatment of anaphylaxis. In the U.S. alone, Epinephrine used in anaphylaxis represents a market over $1 billion. Epinephrine is used as a drug of choice with initial treatment of suspected anaphylactic reactions. Patients with known allergies are often asked to carry Epinephrine auto injectors. These drug device auto injectors tend to be large and inconvenient to carry around. They also involve an invasive procedure that is to say an injection into the lateral thigh. This has led to episodes where patients have postponed this injection leading to an adverse clinical outcome. We believe that the oral inhalation route will provide more than adequate levels of Epinephrine. In addition, this noninvasive step has the potential to prevent untoward outcomes secondary to delaying treatment for fear of an injection.
Epinephrine is in the early technical assessment phase. Preclinical work is expected to begin in the second quarter of this year followed by clinical trials beginning in the first quarter of 2017.
For those that may have questions whether an inhaled medication is suitable for use during the initial phase of an anaphylactic reaction, patients typically know when they are having the reaction. This is well before the full physiologic effects of anaphylaxis become apparent. This is when they typically take an antihistamine, for example, Benadryl because they do not want to inject themselves thinking that the Benadryl will help. Well, it doesn’t. This product will now offer them a noninvasive option. Clearly, there is a very substantial U.S. and global market already for Epinephrine including millions of pediatric and young adult patients. The market is dominated by one player [Mylan]. We will be pursuing partners in which to penetrate this established market with a product that addresses a significant unmet medical need. " Read more: mnkd.proboards.com/thread/5129/mnkd-investors-cc-slides-16#ixzz411J1bXsHMylan Confirms Availability of EpiPen® (epinephrine injection) Auto-Injector for U.S. Patients Affected by Sanofi's Auvi-Q® (epinephrine injection, USP) Recallwww.prnewswire.com/news-releases/mylan-confirms-availability-of-epipen-epinephrine-injection-auto-injector-for-us-patients-affected-by-sanofis-auvi-q-epinephrine-injection-usp-recall-300168925.htmlAccording to Sanofi, Auvi-Q® products have been found to potentially have inaccurate dosage delivery. If a patient experiencing a serious allergic reaction did not receive the intended dose, there could be significant health consequences. [ Imagine Mnkd partners with Mylan for inhaled Epinephrine to beat Sanofi]
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Post by lakers on Feb 23, 2016 12:30:20 GMT -5
5) Did Not Criticize Sanofi Marketing Strategy But Matt Clearly Thought Different Direction Would Have Helped 6) Matt Was Not Lead Person Working With Sanofi Last Year But Was On The Committee 7) Mat Said Sanofi Listened To Mannkind's Suggestions Last Year But Did Things Their Way 8) Large Organizational Structure & Diabetes Drug Pipeline Conflicts At Sanofi Hurt Afrezza Marketing & Sales 9) Mannkind Is A Much Smaller Company & More Nimble To Market Afrezza More Efficiently & Effectively 10) Despite Sanofi's reduced Sales Focus on Afrezza Scripts Are Still Doing Well & Slowly Growing
Conflict of interest. Mnkd disagreed with Sanofi in JAC but was ignored/overruled. Some thought Mnkd had no ground against Sanofi if Mnkd agreed w/ Sanofi's Marketing plan. Matt was a JAC member. Now he has to play nice to get some indemnity from Sanofi.
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Post by lakers on Feb 23, 2016 0:13:14 GMT -5
Hopefully they are resolving it with a cash settlement ! It means cash settlement.
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Post by lakers on Feb 22, 2016 14:31:19 GMT -5
Mnkd and Sanofi are in process of resolving the (licensing) agreement, I learnt. The 4Q15 ER CC date will be on Mon 2/29/16, TBA'ed shortly.
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Post by lakers on Feb 19, 2016 20:50:50 GMT -5
Sorry to pour cold water on this thread but if you do a simple search for oxytocin and mannkind you'll come up with this as the first hit. www.mintakafoundation.org/our-projects/maternal-health/If I remember correctly, Matt spoke about this several months ago. Also doing a search on here brings up an older thread that dispels Monash as the company. With all the research Lakers does, you'd think he would have figured out there is no link between Mannkind and Monash with Oxytocin especially when I just figured it out in less than 10 seconds typing it into google. The fact is it is another nonprofit that happens to have M as the first letter of its name. You miss the point. Monash uses TS for pain med. That's new. Monash has been doing research for GSK. Oxytocin was one example.
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