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Success cases

Closed gaps in IND submission

Deffai provided technical and thorough assessment from the lens of former FDA reviewers. Successfully identified and closed gaps for a gene-therapy IND submission.

IND review for AAV gene therapy combination product for genetic disorders.

Success cases

Prevented a clinical hold

Deffai prevented a potential clinical hold after reviewing INTERACT package, gave a small team the technical depth of a former FDA director.

INTERACT assessment for human tissue extract for neurodegenerative indication.

Success cases

Surfaced critical Pre-BLA gaps

Deffai identified critical deficiencies after reviewing Phase 2/3 clinical data, and supported a better preparation of pre-BLA meeting.

Pre-BLA clinical assessment for Phase 2/3 study for oncology.

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