FDA LABEL http://hcp.afrezza.com/afrezza.pdf
WEEKLY NUMBERS http://investorshub.advfn.com/boards/read_msg.aspx?message_id=116919069
Many Afrezza users have reported rapid drops in A1c
Yeah, but in the only clinical trials that compared Afrezza to rapid acting insulins, Afrezza did no such thing.
Straight from the label:
Absolute HgA1c reduction:
Afrezza : 0.21
Rapid I : 0.40
% of patients reducing by 7% or more:
Rapid I: 27.1%
And there is your problem. Tweets do not counter clinical trial data.
Afrezza avoids the needle, for sure.But is it better?
It has a faster/narrower spike. BUT, to take advantage of this, the user need to know how to use it.
Perhaps a few users have got it down, and do better. But that does not work for the masses.
MNKD really needs to figure out how to work with the new electronic glucose monitors to solve this issue.
p.s. Reading the Mannkind report at FDA.GOV provides plenty of clues why Afrezza is a failure. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM390865.pdf
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic products for patients.
AFREZZA® (pronounced uh-FREZZ-uh) is a rapid-acting inhaled insulin indicated to improve glycemic control in adults with diabetes. AFREZZA was approved by the FDA in 2014. MannKind has a global licensing agreement with Sanofi for the development and commercialization of AFREZZA. Sanofi is responsible for global commercial, regulatory and development activities and. MannKind manufactures AFREZZA at its manufacturing facility in Danbury, CT.
AFREZZA utilizes our proprietary Technosphere® formulation technology , which is based on a class of organic molecules that are designed to self-assemble into small particles onto which drug molecules can be loaded. We believe Technosphere represents a versatile drug delivery platform that may allow pulmonary administration of certain drugs that currently require administration by injection, such as GLP-1. Pulmonary administration provides convenience for the patient and we believe a major advantage of drugs inhaled as Technosphere formulations is that they have been shown to be absorbed very rapidly into the arterial circulation, essentially mimicking intra-arterial administration. MannKind is also developing other inhalation technologies, including an innovative line of patient-focused, breath-activated, dry powder inhalers and inhalation profiling to characterize patient inhalation. - See more at: http://www.mannkindcorp.com/about-us-overview.htm#sthash.6MYBImtD.dpuf
Alfred E. Mann, Founder (Deceased)
Alfred E. Mann had been one of MNKD's directors since April 1999, Chairman of the Board since December 2001 and Executive Chairman since January 2015. He also served as our Chief Executive Officer from October 2003 until January 2015. Mr. Mann has founded and largely funded 14 companies in his career. Nine were acquired at an overall total of almost $8 billion, and three companies became public. In addition to MannKind, he is currently involved with:
• Bioness, which develops and manufactures systems to address neural deficits and to restore controlled function of paralyzed limbs;
• Second Sight, which is developing a visual prosthesis to restore sight to the blind;
• IncuMed, which is developing novel percutaneous seals for various applications;
• PerQFlo, which is developing drug delivery systems; and
• RoundTrip, which is developing location and identification technology.
In 1993, Mr. Mann founded and served as Chairman and Chief Executive Officer of MiniMed Inc. until August 2001 when it was acquired by Medtronic, Inc. Medtronic MiniMed develops, manufactures and distributes microinfusion systems and continuous glucose monitoring systems that have revolutionized the treatment of Type 1 diabetes. Mr. Mann founded and funded Medical Research Group (MRG), a developer of an artificial pancreas. MRG was also acquired by Medtronic in 2001. Mr. Mann also founded and served as the Chairman of the Board and Chief Executive Officer of Advanced Bionics Corporation from its founding in 1993 until it was acquired by Boston Scientific Corporation in 2004. Advanced Bionics developed neurostimulation devices for various neural deficits, including cochlear stimulators. Previously, Mr. Mann founded and was Chairman of the Board and CEO of Pacesetter Systems, Inc., which developed, manufactured and distributed cardiac pacemakers, from 1972 until 1985 when it was acquired by Siemens, AG. From 1985 to September 1992, Mr. Mann continued to serve as Chairman and CEO of the successor company, Siemens-Pacesetter, Inc., Pacesetter is now the Cardiac Rhythm Management unit of St. Jude Medical. Prior to 1972, he was President of Spectrolab, an electro-optical and aerospace systems company, and Heliotek, a semiconductor and electro-optical components manufacturer. Mr. Mann founded these companies in 1956 and 1960, respectively, sold them to Textron Inc. in 1960 and continued to lead them until 1972, when he left for Pacesetter. They are now part of the Boeing Company.
Mr. Mann founded and endowed, and from 1985 until 2006 served as Chairman of the Board of Trustees of The Alfred Mann Foundation, a nonprofit research organization devoted to development of advanced medical products in a variety of fields. Mr. Mann is currently Chairman of the Board of Trustees of the Alfred Mann Institutes at the University of Southern California, Purdue University, and The Technion Institute (Israel), all of these medical research foundations founded and endowed principally by Mr. Mann. He also serves as a Trustee for the University of Southern California, as a member of the Board of Overseers of the Keck USC School of Medicine, and as the Chairman of the Southern California Biomedical Council, a nonprofit association dedicated to the fostering of the bio-medical industry in the Los Angeles Metropolitan area. Alfred Mann also serves as a Director of the Nevada Cancer Institute.
Mr. Mann holds B.A. and M.S. degrees in physics from the University of California, Los Angeles and honorary doctorate degrees from the University of Southern California, The Johns Hopkins University, Western University and the Technion Institute (Israel). Mr. Mann is also a member of the National Academy of Engineering.
Ronald J. Consiglio has been one of our directors since October 2003. Since 1999, Mr. Consiglio has been the managing director of Synergy Trading, a securities-trading partnership. From 1999 to 2001, Mr. Consiglio was Executive Vice President and Chief Financial Officer of Trading Edge, Inc., a national automated bond-trading firm. From January 1993 to 1998 Mr. Consiglio served as Chief Executive Officer of Angeles Mortgage Investment Trust, a publicly traded Real Estate Investment Trust. His prior experience includes serving as Senior Vice President and Chief Financial Officer of Cantor Fitzgerald & Co. and as a member of its board of directors. Mr. Consiglio has served as a member of the board of trustees for the Metropolitan West Funds since 2003. Mr. Consiglio is a certified public accountant and holds a bachelor’s degree in accounting from California State University at Northridge
MannKind Corporation, a development stage company, engages in the discovery, development, and commercialization of therapeutic products for the treatment of diabetes and cancer. Its lead investigational product candidate, the Technosphere Insulin System, is in phase III clinical trials in the United States, Europe, and Latin America for the treatment of diabetes. This dry powder therapy consists of Technosphere particles onto which insulin molecules are loaded. These loaded particles are then aerosolized and inhaled into the deep lung using its proprietary MedTone inhaler. The company is also developing therapies for the treatment of solid tumor cancers. The lead product candidate in this program, MKC1106-PP, which is in phase I clinical trial is intended for the treatment of various solid-tumor cancers, including ovarian, colorectal, pancreatic, renal, breast, and prostate carcinomas and melanoma. MannKind was founded in 1991 and is headquartered in Valencia, CA.