No additional studies required, just more information, as is required for any decision process it seems today. Can't blame the FDA with the area of responsibility they have in desiring to have all the information they require for a sound decision. BD
Johnson & Johnson(JNJ - Cramer's Take - Stockpickr) said late Tuesday that the Food and Drug Administration asked it for additional data before it will approve its paliperidone palmitate, an investigational once-monthly intramuscular injection for schizophrenia. The company, which said regulators will not require any additional studies, is currently evaluating the letter and will work with the agency to resolve any outstanding questions.