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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