Wednesday, June 29, 2011

Weeden update


MannKind: We met with management and continue to feel comfortable with how discussions are proceeding with the FDA regarding the new type 1 and type 2 bridging studies with MannKind’s Afrezza rapid-acting insulin and Gen2 inhaler.
The company is waiting to hear back from the FDA regarding the timing for their next scheduled meeting. Assuming both studies can start enrollment in 3Q11 and complete enrollment in 2H12, this would imply a 2Q/3Q13 FDA approval and US launch (in-line with our current expectations). Management continues to pursue minimally dilutive options for financing.