Adam F from "The Street" redefines the term "clinically significant" for FEV1 reduction in his article titled:

"MannKind's Mysterious Lung-Safety Study Is Open But Shhh...Don't Talk About It"

http://www.thestreet.com/story/11897731/2/mannkinds-mysterious-lung-safety-study-is-open-but-shhhdont-talk-about-it.html

Adam makes the statement:

"The chart above is reprinted from the lung-safety study results published in Diabetes, Obesity & Metabolism. It shows a statistically significant, 34 ml relative decrease in forced vital capacity for Afrezza compared to usual care after 24 months."

The Problem:

Adam's definition of "clinically significant" does not:is not aligned with:

1. Definition of "statistically significant" within this trial:

Non-inferiority = annualized change is no greater than 50 mL/year.

The 34 and 37 mL decrease was below this number, thus the P value being less than 0.05.

2. Definition of "statistically significant" from the American Thoracic Society:

The American Thoracic Society (ATS)

recommends a 15% year-to-year FEV1

decline for clinical significance.

With a baseline of 3.24 and 3.29, the 34 mL reduction equates to:

10%

He defends this term vigorously in the comments section, and is a blatant misrepresentation of facts to mislead investors, as I'm fairly confident Adam understands statistics, or I hope so, as his mantra is "Data Are".

Well, "Data Are" was misrepresented.

I'm mad as hell, and I'm not going to take it any more!