Shares of SkyePharma were sliding this morning after the UK developer told investors that the FDA would probably come back with a request for more data on its lead drug Flutiform, adding to the time it will take to reach the marketplace.
SkyePharma based its prediction on an analysis of its 74-day letter from the FDA, concluding that more clinical work would probably be needed before the agency approves the asthma drug. Analysts appeared concerned, but not overly alarmed.
"Potentially it is significant because there might be more data needed, but it's not significant enough for me to start reviewing my financial model at this point," analyst Jacob Plieth at Edison Investment Research tells Reuters.
- here's the report