Northerner
Admin (Retired)
- Relationship to Diabetes
- Type 1
MannKind Corp said the U.S. Food and Drug Administration extended the review date of its inhaled insulin treatment by three months, sending the company's shares down as much as 22 percent before the bell.
The news comes less than a week after an advisory panel to the FDA recommended approving the treatment, Afrezza, but said longer-term studies would be required to gauge the risk of lung cancer and other potential side-effects.
MannKind said on Monday the new review date of July 15 was set to give the FDA time to fully review information it had submitted.
http://www.foxbusiness.com/industri...delays-decision-on-inhaled-insulin-treatment/
The news comes less than a week after an advisory panel to the FDA recommended approving the treatment, Afrezza, but said longer-term studies would be required to gauge the risk of lung cancer and other potential side-effects.
MannKind said on Monday the new review date of July 15 was set to give the FDA time to fully review information it had submitted.
http://www.foxbusiness.com/industri...delays-decision-on-inhaled-insulin-treatment/