Nabi Biopharmaceuticals and the FDA have reached an agreement on a Special Protocol Assessment (SPA) for a Phase II trial of NicVAX, the company's anti-smoking vaccine. An SPA is a process by which sponsors and the FDA reach agreement on the design and size of clinical trials.
"This SPA provides us with a clear, well-defined path to support approval of NicVAX and further strengthens our leadership position to bring the first smoking cessation vaccine to market," said Dr. Raafat Fahim, President and CEO of Nabi. "Ideally, we would prefer to initiate Phase III testing with a strategic partner and we continue to pursue all options through our strategic alternatives process. The SPA further reduces the regulatory risks associated with the NicVAX program for both Nabi and its potential partners.
- here's Nabi's release