Exposing the Corruption of the 2017 Endo Consensus on T2D

[sayhey24]

Feb 21, 2017 21:52:46 GMT -5 mnholdem said:

Quick note: Seeking Alpha typically butchers transcripts (I sometimes wonder if the hire staff in India like my credit card company). The correct terminology for the new KPI discussed between the FDA and diabetes KOLs last summer is "Time in Range" rather than "Time and Range".

Ha! - thanks, I thought Ray had a new name for it.

[agedhippie]

Feb 21, 2017 21:42:39 GMT -5 sayhey24 said:

Feb 21, 2017 20:50:41 GMT -5 agedhippie said:

I think it has to be a G5 rather than a Libre as the Libre is only approved for blinded use. The Libre also has issues with correctly detecting lows which makes it unsuitable for this use.

I don't see it as either or, I would do two arms even if only the Dexcom arm can be submitted for the time and range for the FDA.  The Libre is approved for patient readings only in consultation with the doctor.  How that consultation is constructed and who doctor/PWD takes the readings is up to the doctor.  It does not have to be blinded as some doctors are currently doing.  There is little value for the PWD not seeing the readings real-time which is why some other doctors are having the PWD buy their own reader from the doctor and part of the consultation is for the PWD to keep a daily log which is reviewed in office every 2 weeks and compared with the readings done by the doctor. 

I think that any official work (trials) could not use the unblinded Libre as it is not FDA approved in that role so getting the FDA to approve the protocol may not work. As you say there is little value over the long term to a blinded Libre. My suspicion is that the error rate at low glucose levels will be a problem (are you in range or is it an error?) for a trial.

[peppy]

additional information:
the dexcom gives blood glucose data in mg/dl.

www.dexcom.com/get-started-cgm?utm_source=website&utm_campaign=70133000001LlpgAAC&gclid=CjwKEAiAirXFBRCQyvL279Tnx1ESJAB-G-QvZMukg0BAnp6HNSqVlA0MuYUqdYTlC8c9qrlrPPuQyhoCcy_w_wcB

Libre the glucose data is mmole/liter.
diatribe.org/abbott-freestyle-libre-transforming-glucose-monitoring-through-utter-simplicity-fingersticks

I know mg/dl by heart.

I would have to learn mm/l

www.diabeteschart.org/bloodsugarchart.html

like Celsius and Fahrenheit

miles and kilometers

pounds and kilograms

heh

[agedhippie]

Feb 22, 2017 9:06:18 GMT -5 peppy said:

additional information:
the dexcom gives blood glucose data in mg/dl.

www.dexcom.com/get-started-cgm?utm_source=website&utm_campaign=70133000001LlpgAAC&gclid=CjwKEAiAirXFBRCQyvL279Tnx1ESJAB-G-QvZMukg0BAnp6HNSqVlA0MuYUqdYTlC8c9qrlrPPuQyhoCcy_w_wcB

Libre the glucose data is mmole/liter.
diatribe.org/abbott-freestyle-libre-transforming-glucose-monitoring-through-utter-simplicity-fingersticks

I know mg/dl by heart.

I would have to learn mm/l

www.diabeteschart.org/bloodsugarchart.html

like Celsius and Fahrenheit

miles and kilometers

pounds and kilograms

heh

Roughly speaking multiply by 18 to get mg/dl although I tend to use 20 because it's easier and I am idle.

[peppy]

Feb 22, 2017 9:11:36 GMT -5 agedhippie said:

Feb 22, 2017 9:06:18 GMT -5 peppy said:

additional information:
the dexcom gives blood glucose data in mg/dl.

www.dexcom.com/get-started-cgm?utm_source=website&utm_campaign=70133000001LlpgAAC&gclid=CjwKEAiAirXFBRCQyvL279Tnx1ESJAB-G-QvZMukg0BAnp6HNSqVlA0MuYUqdYTlC8c9qrlrPPuQyhoCcy_w_wcB

Libre the glucose data is mmole/liter.
diatribe.org/abbott-freestyle-libre-transforming-glucose-monitoring-through-utter-simplicity-fingersticks

I know mg/dl by heart.

I would have to learn mm/l

www.diabeteschart.org/bloodsugarchart.html

like Celsius and Fahrenheit

miles and kilometers

pounds and kilograms

heh

Roughly speaking multiply by 18 to get mg/dl although I tend to use 20 because it's easier and I am idle.

we have been given the formula's all our lives.

2.2 pounds per kilo.

°F to °C -nDeduct 32, then multiply by 5, then divide by 9.

1 pound is 454 grams.

one ounce is 28.5 grams.

one gram is a centimeter cubed of water.

heh.

do it.

These glucose monitors are computers.

[rockstarrick]

Feb 22, 2017 9:17:05 GMT -5 peppy said:

Feb 22, 2017 9:11:36 GMT -5 agedhippie said:

Roughly speaking multiply by 18 to get mg/dl although I tend to use 20 because it's easier and I am idle.

we have been given the formula's all our lives.

2.2 pounds per kilo.

°F to °C -nDeduct 32, then multiply by 5, then divide by 9.

1 pound is 454 grams.

one ounce is 28.5 grams.

one gram is a centimeter cubed of water.

heh.

do it.

These glucose monitors are computers.

Conversions and dimensional analasys, gotta love it.

[agedhippie]

Feb 22, 2017 9:17:05 GMT -5 peppy said:

Feb 22, 2017 9:11:36 GMT -5 agedhippie said:

Roughly speaking multiply by 18 to get mg/dl although I tend to use 20 because it's easier and I am idle.

we have been given the formula's all our lives.

2.2 pounds per kilo.

°F to °C -nDeduct 32, then multiply by 5, then divide by 9.

1 pound is 454 grams.

one ounce is 28.5 grams.

one gram is a centimeter cubed of water.

heh.

do it.

These glucose monitors are computers.

I've had this particular argument with meter manufacturers before

In each country the regulator insists that the meter is locked to local units. The concern is that the user may be confused if somehow the different units. I would have though units were far enough apart for this not to be a problem but apparently not.

[peppy]

Feb 22, 2017 11:41:07 GMT -5 agedhippie said:

Feb 22, 2017 9:17:05 GMT -5 peppy said:

we have been given the formula's all our lives.

2.2 pounds per kilo.

°F to °C -nDeduct 32, then multiply by 5, then divide by 9.

1 pound is 454 grams.

one ounce is 28.5 grams.

one gram is a centimeter cubed of water.

heh.

do it.

These glucose monitors are computers.

I've had this particular argument with meter manufacturers before

In each country the regulator insists that the meter is locked to local units. The concern is that the user may be confused if somehow the different units. I would have though units were far enough apart for this not to be a problem but apparently not.

well I see what they mean. Diabetics are supposed to be bright enough to use subq insulin and not die. Only because the physician told them what to do.

but too stupid to see mg/dl over mm/l

I am surprised we are allowed to pump our own gas and decide between regular unleaded, or premium.

[mango]

• Federal lawsuit accuses Sanofi SA, Novo Nordisk and Eli Lilly & Co of simultaneously increasing the price of insulin
Research firm found prices of drug from three companies increased between 99 and 120 percent from 2012 to 2016
Lawsuit plaintiffs claim that some skipped meals or underdosed their insulin because they could not afford treatment otherwise
Senator Bernie Sanders and Rep. Elijah Cummings asked federal antitrust regulators to investigate possible insulin price collusion by the three companies

• All three pharmaceutical companies deny the allegations claimed in the lawsuit

www.dailymail.co.uk/news/article-4250932/Lawsuit-accuses-insulin-manufacturers-collusion.html


CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM – 2017 EXECUTIVE SUMMARY


DISCLOSURES

Dr. Jeffrey R. Garber reports that he does not have any relevant financial relationships with any commercial interests.

Dr. Alan J. Garber reports that he is a consultant for Novo Nordisk and Intarcia

Dr. W. Timothy Garvey reports that he is a consultant for AstraZeneca, Janssen, Eisai, Takeda, Novo Nordisk, Alexion, and Merck. He has also received research grants from Merck, Weight Watchers, Sanofi, Eisai, AstraZeneca, Lexicon, Pfizer, Novo Nordisk, and Elcelyx. Dr. Garvey is a shareholder in ISIS Pharmaceuticals, Novartis, Bristol Myers Squibb, Pfizer, Merck, and Eli Lilly.

Dr. Martin Julian Abrahamson reports that he is a consultant for Novo Nordisk, WebMD Health Services, and Health IQ.

Dr. Joshua I. Barzilay reports that he does not have any relevant financial relationships with any commercial interests.

Dr. Lawrence Blonde reports that he is a consultant for AstraZeneca, GlaxoSmithKline, Intarcia, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, and Sanofi. He is also a speaker for AstraZeneca, Janssen Pharmacueticals, Inc., Merck & Co., Inc., Novo Nordisk, and Sanofi. Dr. Blonde has received research grant support from AstraZeneca, Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Novo Nordisk, and Sanofi.

Dr. George Grunberger reports that he has received speaker honoraria from Eli Lilly, BI-Lilly, Novo Nordisk, Sanofi, Janssen, and AstraZeneca. He has received research funding from AstraZeneca, Eli Lilly, Lexicon, and Medtronic.

Dr. Zachary Bloomgarden reports that he is a consultant for AstraZeneca, Johnson & Johnson, Merck, Intarcia, and Novartis. He is also a speaker for Merck, AstraZeneca, and Johnson & Johnson. He is a stock shareholder for Allergan, Pfizer, Zimmer Biomet, and Novartis.

Dr. Yehuda Handelsman reports that he is a consultant for Amarin, Amgen, AstraZeneca, Boehringer Ingelheim (BI), Janssen, Eli Lilly, Eisai, Intarcia, Merck, Novo Nordisk, Sanofi, and Regeneron. He is a speaker for Amarin, Amgen, AstraZeneca, BI-Lilly, Janssen, Novo Nordisk, Sanofi, and Regeneron. Dr. Handelsman has also received grant support from Amgen, AstraZeneca, BI, Esperion, Grifols, Hamni, GlaxoSmithKline, Lexicon, Merck, Novo Nordisk, and Sanofi.

Dr. Michael A. Bush reports that he is an Advisory Board Consultant for Janssen and Eli Lilly. He is on the speaker’s bureau for Takeda, Eli Lilly, Novo Nordisk, AstraZeneca, and Boehringer Ingelheim.

Dr. Irl B. Hirsch reports that he is a consultant for Abbott Diabetes Care, Roche, Intarcia, and Valeritas.

Dr. Samuel Dagogo-Jack reports that he is a consultant for Merck, Novo Nordisk, Janssen, and Boehringer Ingelheim. He has received research grants from Amgen. Additionally, AstraZeneca, Novo Nordisk, and Boehringer Ingelheim have clinical trial contracts with the University of Tennessee for studies in which Dr. Dagogo-Jack serves as the Principal Investigator or Co-Investigator.

Dr. Paul S. Jellinger reports that he has received speaker honoraria from BI-Lilly, AstraZeneca, Novo Nordisk, Merck, and Amgen.

Dr. Ralph Anthony DeFronzo reports that he is on the Advisory Board for AstraZeneca, Novo Nordisk, Janssen, Boehringer Ingelheim, Intarcia, and Ecelyx. He is also a speaker for Novo Nordisk and AstraZeneca. Dr. DeFronzo has received research grant support from Boehringer Ingelheim, Takeda, Janssen, and AstraZeneca.

Dr. Janet B. McGill reports that she is a consultant for Boehringer Ingelheim, Janssen, Merck, Novo Nordisk, Calibra, Dynavax, Valertias, and Intarcia. She is also a speaker for Janssen. Dr. McGill has received research grant support from Novartis, Dexcom, Bristol Myers Squibb, and Lexicon.

Dr. Daniel Einhorn reports that he is a consultant for Eli Lilly, Takeda, Novo Nordisk, Adocia, Sanofi, Epitracker, Janssen, Intarcia, Glysens, and Freedom-Meditech and has received research grant support from Novo Nordisk, Eli Lilly, AstraZeneca, Eisai, Janssen, and Sanofi. He is also a shareholder of Halozyme.

Dr. Paul D. Rosenblit reports that he is a consultant for AstraZeneca and a speaker for AstraZeneca (Bristol Myers Squibb), Boehringer Ingelheim, GlaxoSmithKline, Janssen, Merck, Novo Nordisk, and Takeda. He has also received research grant support from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, GlaxoSmithKline, Ionis, Eli Lilly, Lexicon, Merck, Novo Nordisk, Orexigen, Pfizer, and Sanofi.

Dr. Vivian A. Fonseca reports that he is a consultant for Takeda, Novo Nordisk, Sanofi, Eli Lily, Pamlabs, AstraZeneca, Abbott, Boehringer Ingelheim, Janssen and Intarcia. He is a speaker for Takeda, AstraZeneca, and Sanofi. Dr. Fonseca has also received research grants from Novo Nordisk, Asahi, Eli Lilly, Abbott, Endo Barrier, Bayer, and Gilead.

Dr. Guillermo E. Umpierrez reports that he is a consultant for Sanofi and Glytec. He also received research grant support from Merck, Sanofi, Boehringer Ingelheim, AstraZeneca, and Novo Nordisk.

Dr. Jeffrey I. Mechanick reports that he is a consultant for Abbott Nutrition International.

Dr. Stephanie Adams reports that she does not have any relevant financial relationships with any commercial interests.


www.aace.com/sites/all/files/diabetes-algorithm-executive-summary.pdf

[peppy]

Feb 22, 2017 23:14:45 GMT -5 mango said:

• Federal lawsuit accuses Sanofi SA, Novo Nordisk and Eli Lilly & Co of simultaneously increasing the price of insulin
Research firm found prices of drug from three companies increased between 99 and 120 percent from 2012 to 2016
Lawsuit plaintiffs claim that some skipped meals or underdosed their insulin because they could not afford treatment otherwise
Senator Bernie Sanders and Rep. Elijah Cummings asked federal antitrust regulators to investigate possible insulin price collusion by the three companies

• All three pharmaceutical companies deny the allegations claimed in the lawsuit

www.dailymail.co.uk/news/article-4250932/Lawsuit-accuses-insulin-manufacturers-collusion.html


CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM – 2017 EXECUTIVE SUMMARY


DISCLOSURES

Dr. Jeffrey R. Garber reports that he does not have any relevant financial relationships with any commercial interests.

Dr. Alan J. Garber reports that he is a consultant for Novo Nordisk and Intarcia

Dr. W. Timothy Garvey reports that he is a consultant for AstraZeneca, Janssen, Eisai, Takeda, Novo Nordisk, Alexion, and Merck. He has also received research grants from Merck, Weight Watchers, Sanofi, Eisai, AstraZeneca, Lexicon, Pfizer, Novo Nordisk, and Elcelyx. Dr. Garvey is a shareholder in ISIS Pharmaceuticals, Novartis, Bristol Myers Squibb, Pfizer, Merck, and Eli Lilly.

Dr. Martin Julian Abrahamson reports that he is a consultant for Novo Nordisk, WebMD Health Services, and Health IQ.

Dr. Joshua I. Barzilay reports that he does not have any relevant financial relationships with any commercial interests.

Dr. Lawrence Blonde reports that he is a consultant for AstraZeneca, GlaxoSmithKline, Intarcia, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, and Sanofi. He is also a speaker for AstraZeneca, Janssen Pharmacueticals, Inc., Merck & Co., Inc., Novo Nordisk, and Sanofi. Dr. Blonde has received research grant support from AstraZeneca, Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Novo Nordisk, and Sanofi.

Dr. George Grunberger reports that he has received speaker honoraria from Eli Lilly, BI-Lilly, Novo Nordisk, Sanofi, Janssen, and AstraZeneca. He has received research funding from AstraZeneca, Eli Lilly, Lexicon, and Medtronic.

Dr. Zachary Bloomgarden reports that he is a consultant for AstraZeneca, Johnson & Johnson, Merck, Intarcia, and Novartis. He is also a speaker for Merck, AstraZeneca, and Johnson & Johnson. He is a stock shareholder for Allergan, Pfizer, Zimmer Biomet, and Novartis.

Dr. Yehuda Handelsman reports that he is a consultant for Amarin, Amgen, AstraZeneca, Boehringer Ingelheim (BI), Janssen, Eli Lilly, Eisai, Intarcia, Merck, Novo Nordisk, Sanofi, and Regeneron. He is a speaker for Amarin, Amgen, AstraZeneca, BI-Lilly, Janssen, Novo Nordisk, Sanofi, and Regeneron. Dr. Handelsman has also received grant support from Amgen, AstraZeneca, BI, Esperion, Grifols, Hamni, GlaxoSmithKline, Lexicon, Merck, Novo Nordisk, and Sanofi.

Dr. Michael A. Bush reports that he is an Advisory Board Consultant for Janssen and Eli Lilly. He is on the speaker’s bureau for Takeda, Eli Lilly, Novo Nordisk, AstraZeneca, and Boehringer Ingelheim.

Dr. Irl B. Hirsch reports that he is a consultant for Abbott Diabetes Care, Roche, Intarcia, and Valeritas.

Dr. Samuel Dagogo-Jack reports that he is a consultant for Merck, Novo Nordisk, Janssen, and Boehringer Ingelheim. He has received research grants from Amgen. Additionally, AstraZeneca, Novo Nordisk, and Boehringer Ingelheim have clinical trial contracts with the University of Tennessee for studies in which Dr. Dagogo-Jack serves as the Principal Investigator or Co-Investigator.

Dr. Paul S. Jellinger reports that he has received speaker honoraria from BI-Lilly, AstraZeneca, Novo Nordisk, Merck, and Amgen.

Dr. Ralph Anthony DeFronzo reports that he is on the Advisory Board for AstraZeneca, Novo Nordisk, Janssen, Boehringer Ingelheim, Intarcia, and Ecelyx. He is also a speaker for Novo Nordisk and AstraZeneca. Dr. DeFronzo has received research grant support from Boehringer Ingelheim, Takeda, Janssen, and AstraZeneca.

Dr. Janet B. McGill reports that she is a consultant for Boehringer Ingelheim, Janssen, Merck, Novo Nordisk, Calibra, Dynavax, Valertias, and Intarcia. She is also a speaker for Janssen. Dr. McGill has received research grant support from Novartis, Dexcom, Bristol Myers Squibb, and Lexicon.

Dr. Daniel Einhorn reports that he is a consultant for Eli Lilly, Takeda, Novo Nordisk, Adocia, Sanofi, Epitracker, Janssen, Intarcia, Glysens, and Freedom-Meditech and has received research grant support from Novo Nordisk, Eli Lilly, AstraZeneca, Eisai, Janssen, and Sanofi. He is also a shareholder of Halozyme.

Dr. Paul D. Rosenblit reports that he is a consultant for AstraZeneca and a speaker for AstraZeneca (Bristol Myers Squibb), Boehringer Ingelheim, GlaxoSmithKline, Janssen, Merck, Novo Nordisk, and Takeda. He has also received research grant support from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, GlaxoSmithKline, Ionis, Eli Lilly, Lexicon, Merck, Novo Nordisk, Orexigen, Pfizer, and Sanofi.

Dr. Vivian A. Fonseca reports that he is a consultant for Takeda, Novo Nordisk, Sanofi, Eli Lily, Pamlabs, AstraZeneca, Abbott, Boehringer Ingelheim, Janssen and Intarcia. He is a speaker for Takeda, AstraZeneca, and Sanofi. Dr. Fonseca has also received research grants from Novo Nordisk, Asahi, Eli Lilly, Abbott, Endo Barrier, Bayer, and Gilead.

Dr. Guillermo E. Umpierrez reports that he is a consultant for Sanofi and Glytec. He also received research grant support from Merck, Sanofi, Boehringer Ingelheim, AstraZeneca, and Novo Nordisk.

Dr. Jeffrey I. Mechanick reports that he is a consultant for Abbott Nutrition International.

Dr. Stephanie Adams reports that she does not have any relevant financial relationships with any commercial interests.


www.aace.com/sites/all/files/diabetes-algorithm-executive-summary.pdf

In 1978, researchers at a burgeoning biotechnology company called Genentech announced that they had introduced a human gene for insulin into a safe strain of E. coli bacteria, which then produced the protein. Genentech partnered with Lilly, which brought engineered human insulin to the market in 1982 under the brand name Humulin, the first recombinant DNA drug product in the world.

Biotechnology allowed people with diabetes to take insulin that is virtually identical to the body's version. But that was just the beginning for insulin medications. Having the ability to tweak the insulin gene, scientists started to develop new-to-nature forms of insulin—called insulin analogs—such as insulin lispro (Humalog) and insulin glargine (Lantus). Analogs have become increasingly popular among prescribers and patients. Engineers build desirable properties into analogs by tweaking their amino acid sequences in ways that force the body to process them faster or slower than plain human insulin. These new attributes give people with diabetes more options for controlling blood glucose.

Lilly agreed to take Diabetes Forecast on a tour of parts of its Indianapolis insulin production complex. Covering 1.38 million square feet, or 18 soccer fields, the Lilly facilities in Indianapolis are constantly generating Humulin and the insulin analog Humalog.

At Lilly, insulin-making E. coli is grown in 50,000-liter tanks called fermentors. There are more than 5,000 tanks on site.According to Lilly, a batch of insulin from one fermentor could produce a year's supply of insulin for thousands of people. "Our facilities are designed to produce insulin crystals in multiple metric-ton quantities," Walsh says.

Small tubes of the bacteria have been stored in a freezer at minus 70 degrees Celsius (minus 94 degrees Fahrenheit) for decades. Lilly produced a granddaddy batch of E. coli, now referred to as the "master cell bank," sometime in the 1980s. It has gone on to seed every batch of Humulin to this day

www.diabetesforecast.org/2013/jul/making-insulin.html

[agedhippie]

Lets be clear on what this lawsuit is and isn't. This is about the pricing model and the role of PBMs. The complaint is about the gap between the retail price and the price a PBM pays with the argument that the insulin manufacturers increased the retail price while keeping the PBM price constant in order to increase the commission paid by insurers on cost savings.

It isn't a federal or state action, it's a class action law suit. It is not about pricing collusion (which makes sense because it's difficult to prove if the defendents are half way competent). It isn't about smashing the insulin cartel at all. The real target is PBM pricing and if this works they will use it as a cookie cutter to go after a lot of other drugs. Likely they chose insulin as the first drug because diabetics have a sympathetic image.

This is ambulance chasing but on the principle of the enemy of my enemy is my friend I am all for it.

[mango]

Let's be clear on this—you can continue defending all you want and giving nothing but your opinions. Not gonna change anyone's mind. Maybe you are not aware of who Scott W. Rothstein is? A crook associated with the largest qui tam case in history that involved Eli Lilly. Inside whistleblowers reported Eli Lilly's unlawful practices with their MARKETING and SALES of Zyprexa. Went into the history books. They keep finding themselves in legal trouble.

This involved over a billion dollars.

Here's the Wiki on it:

Joe Faltaous worked as a Neuroscience Sales Specialist for Eli Lilly for two years before resigning after expressing concerns about Eli Lilly’s practices. Joe complained of Lilly’s illegal marketing, promotion and sale of Zyprexa to children and in higher-than-recommended dosages to adults. Joe also complained that, as part of the marketing and promotional schemes, Lilly encouraged physicians by means of monetary payments. In 2009, Faltaous and 9 other whistleblowers won a settlement with Eli Lilly in a civil qui tam action in U.S. District Court.[19]

en.m.wikipedia.org/wiki/Qui_tam

[mango]

To suggest nothing is going on and everything is rainbows and sunshine is the dumbest thing I have ever heard.

[dreamboatcruise]

Feb 21, 2017 21:42:39 GMT -5 sayhey24 said:

Feb 21, 2017 20:50:41 GMT -5 agedhippie said:

I think it has to be a G5 rather than a Libre as the Libre is only approved for blinded use. The Libre also has issues with correctly detecting lows which makes it unsuitable for this use.

I don't see it as either or, I would do two arms even if only the Dexcom arm can be submitted for the time and range for the FDA.  The Libre is approved for patient readings only in consultation with the doctor.  How that consultation is constructed and who doctor/PWD takes the readings is up to the doctor.  It does not have to be blinded as some doctors are currently doing.  There is little value for the PWD not seeing the readings real-time which is why some other doctors are having the PWD buy their own reader from the doctor and part of the consultation is for the PWD to keep a daily log which is reviewed in office every 2 weeks and compared with the readings done by the doctor. 

If MNKD can show as much value using the Abbott as the Dexcom this provides some leverage for MNKD with Dexcom and Dexom's partner Verily.  Today, the Libre is much more affordable and fully covered by Medicare and provides a profitable business for the doctors replacing the sensors and reviewing the results every two weeks.  Once MNKD proves time and range can be done and the shift starts away from A1c, Dexcom/Verily/Onduo needs afrezza more than MNKD need Dexcom.  This time and range study is the make or break for MNKD but anyone who has been following afrezza as close as everyone on this MB already knows what the results will be.  Place your bets as IMO these results will determine whether Matt needs to execute on the R/S which will be approved in a few days.

Where is this information coming from?  Are there diabetes forum sites that have patients discussing having Libre readers they acquired from their US docs?

Seems odd that values would be compared if they are coming from the same device.  Is this to see if a patient has the ability to read and write?

Are the sensors the same in the US... according to what I've read the US version only takes readings every 15 minutes.  That would be considerably less useful for dosing... and off label.

[agedhippie]

Feb 23, 2017 13:17:16 GMT -5 mango said:

Let's be clear on this—you can continue defending all you want and giving nothing but your opinions. Not gonna change anyone's mind. Maybe you are not aware of who Scott W. Rothstein is? A crook associated with the largest qui tam case in history that involved Eli Lilly. Inside whistleblowers reported Eli Lilly's unlawful practices with their MARKETING and SALES of Zyprexa. Went into the history books. They keep finding themselves in legal trouble.

Am I wrong about the terms of the lawsuit? No. Next please.