Since 1986, Visx had been directing several procedures refractive eye disorders through the FDA approval procedure that was multistage and to treat corneal pathologies. The costs associated with submitting clinical trial information to the FDA were taking a toll. Difficulties increased radically in September 1994, when Visx's stock price fell 26% with the news that FDA approval was delayed due to compliance irregularities discovered at some clinical testing websites. And its earnings dropped by 19%.
Mark Logan @ Visx, Inc. (A) Case Study Solution
Getting FDA approval was exceptionally important to Visx, as it'd have its foot in the door and be able to sell its excimer laser system in America.
PUBLICATION DATE: March 25, 2009 PRODUCT #: UV2713-PDF-ENG
This is just an excerpt. This case is about ORGANIZATIONAL DEVELOPMENT