Biotech Values

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IF TRUE, that largely negates the assertion that FDA would not bother to inspect unless they were nearing approval and the inference of near-term approval.

ANDA is less transparent. For NDA, inspection doesn't imply approval at all. Inspection is done by district/local office, it is part of review process. There are tons of examples of inspection done without approval. For example, Provenge, FDA requested new trial, FDA also inspected DNDN plant prior to CRL, and raised issues of the plant in CRL. However, plant deficiency was NOT the key reason for rejecting Provenge application.