) to reduce from neutral.
Analyst Annabel Samimy says based on details from his first-quarter review, he talks with company individuals. He believes MannKind may not be able to file its new drug application for Technosphere Insulin (TI) until the second half of 2008.
He notes the company has not yet begun a two-year safety/efficacy study in Type 1 and 2 points, enrollment of which is expected to take one year. He says this comes on top of a complex clinical program that may include up to 5 Phase III studies, two of which may be at least one year.
Based on these timelines, he assumes the launch in early 2010. He cuts his $15 target to $7, 35 times 82 cents 2010 earnings per share estimate and discounted at 35%.