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===Phase 3 Clinical Studies===

--Expanded controlled and uncontrolled trials--
Phase 3 studies are expanded controlled and uncontrolled trials.

--Phase II: Primary evidence->effectiveness has been obtained--
--Phase III: More for effectiveness and safety--
--Phase III: Overall benefit-risk relationship--
1. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase 2,
2. and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.

===An adequate basis for extrapolating the result===

--information to transmit in the physician labeling--
Phase 3 studies also provide an adequate basis for extrapolating the results to the general population and transmitting that information in the physician labeling.

--Several hundred to thousand patients needed--
Phase 3 studies usually include several hundred to several thousand people.

--Failed to pass if unsafe or clearly deficient for its objectives--
In both Phase 2 and 3, CDER can impose a clinical hold if a study is unsafe (as in Phase 1), or if the protocol is clearly deficient in design in meeting its stated objectives.

--Ensure decision not make isolation but base on the current knowledge--
Great care is taken to ensure that this determination is not made in isolation, but reflects current scientific knowledge, agency experience with the design of clinical trials, and experience with the class of drugs under investigation.

*** PRR PhaseIIa has been passed through***
So it has been confirmed that the primary evidence of the effectiveness of CVac has been obtained