The FDA's Endocrinologic and Metabolic Drugs Advisory Committee meets April 1 to discuss Mannkind's (MNKD) AFREZZA NDA.
The company originally submitted the New Drug Application for its ultra fast-acting inhalable insulin in March 2009. A couple of CRLs and clinical trials later, CEO Al Mann hopes this is the long-awaited breakthrough in light of his $1B+ investment to date.
Considering the inherent risk in a binary event such as an Ad comm vote, longs might want to hedge their positions.
Shares are up 12% premarket on heavy volume.
The firm's market cap is ~$2B.