Novus Therapeutics Inc. shares rose nearly 12% in premarket trade on Tuesday after the company said that the Food and Drug Administration had provided guidance on the company's OP-02 drug-device product for otitis media, a type of infection in the middle ear. The company won't need any additional preclinical or clinical studies beyond a planned phase 1 safety study to start phase 2 studies in children, Novus President Catherine Turkel said. Young children are especially at risk of getting these types of infections. Most clear up in a few days, but complications -- though infrequent -- can be serious. Novus has another ear technology, OP-01, but has focused on developing OP-02 since last year. Novus shares have risen 2% over the last three months, compared with a 2.2% rise in the S&P 500 and a 1.5% rise in the Dow Jones Industrial Average