PP Talks -- Is It Common for Compounds to Fail the FDA Approval Process?

1. Stages of FDA Approval Process IND

a. Phase 1 – Safety – 20-100 healthy, 2 yrs.

b. Phase 2 – Effectiveness – 100-500 patients, 2 yrs.

c. Phase 3 – Effectiveness & ADR, 1K-5K, 3.5 yrs.

2. Vaccines

a. Phase I fails = 37%

b. Phase II fails = 69%

c. Phase III fails = 42%

d. Biologics License Application (BLA) application

e. Vacc & Related Biologics Prod Adv Cmte (VRBPAC)

3. Risks

a. New vaccine for new virus

b. Clinical trials never succeed

c. Vaccine induced enhancement

d. Acquire study population

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