OncoSec Medical Inc (ONCSQ)

[hschlauch]

Hi Twiz, a registration study is designed to sufficiently answer specific efficacy and safety questions. These trials are typically large enough to test for statistical significance and they serve as the basis for new drug applications. The FDA evaluates a NDA to determine whether or not a drug should be approved. A registration study, therefore, is the last trial prior to approval or a denial, ie, a complete response letter. Most registration studies are phase 3 trials, but not always.

You can have a phase 2 trial serve as a registration study, but typically you would be required to follow it up with a confirmatory trial after the drug gets approved, assuming it gets approved. In other words, the drug could be marketed while it goes through the confirmatory trial.