Words more powerful than data

WASHINGTON - The use of clever language in the proposed label indication probably saved Organogenesis Inc. from having the recommended indication for its Apligraf engineered skin product severely limited by an FDA advisory panel.

At the meeting, the company presented data showing no statistical significance between Apligraf and standard compression in the primary end points of frequency and time to complete wound closure at up to six months. However, the subgroup of patients whose ulcers were more than a year old at baseline did show significant improvement...