Prosthetic joint infection.
The objective of our development program is to conduct clinical trials and to obtain marketing approval by the FDA and other regulatory authorities. Participation in clinical trials is the first and most preferable route. If participation in clinical trials is not an option, physicians may consider a single-patient expanded access IND. Requests are considered on an individual basis. The general criteria used to evaluate such requests for individual patients are as follows: 1) The patient is diagnosed with PJI; 2) Assessment that the company has an adequate supply of the investigational medicine; and 3) A determination that expanded access will not interfere with the company’s ability to complete clinical trials in a timely fashion or which might otherwise delay marketing approval and ultimately availability to all patients. The company may request additional information, including patient history, in order to fully evaluate the request. If the physician will be the sponsor for the IND, he or she is required to obtain necessary ethical and regulatory clearances, including informed consent, as well as provide reporting on treatment outcomes.