- A request may be premature if:
- The sponsor does not specify the investigational clinical product.
- The sponsor does not provide preclinical proof-of-concept (POC) or other pilot data.
- The sponsor has not conducted any preclinical studies (e.g., proof-of-concept studies) with their intended clinical product.
When will FDA provide guidance?
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/otp-interact-meeting
https://www.fda.gov/media/93740/download
Ann: Updated Strategy and Investor Presentation, page-364
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