They claim FDA 'Fast Track' status.
From their site:
**In drug development, the proof is in the clinical trial…and OncoVAX® has demonstrated outstanding success in early trials. As a result, it has been granted SPA and Fast Track status by the FDA.
Vaccinogen’s OncoVAX® vaccine offers outstanding potential for commercial success, both in the short term and long term. It’s approval for commercial use in Switzerland will yield revenues over the next few months. A vast global market could unfold as soon as 2011, if FDA approval is achieved as expected.
**Vaccinogen has met many of the challenges of commercialization
Automated identity, potency & product characterization for a patient-specific tumor vaccine;
Vaccinogen has a patented sterile manufacturing process for patient-specific tumor vaccines, with the participation of the surgeon and the pathologist in the operating room;
Regulatory approval of commercial manufacturing facility in Holland by Dutch/Swiss Authorities; and
900/m2 facility has five class B manufacturing suites and two class C QC laboratories with a capacity to produce 2,500 OncoVAX® vaccines per year - a production amount sufficient to cover the pivotal Phase III clinical trial and the commercial sales of OncoVAX® in Switzerland.
