Replies to post #544094 on NorthWest Biotherapeutics Inc (NWBO)

[dr_lowenstein]

right, so the fda confirmed that they did not mandate the crossover If fda approved the SAP, that is what it says

[HyGro]

FDA reviews and approves the pre-trial protocol. All other changes that are filed are NOT approved, Sponsors can request FDA to COMMENT on the changes, but it is not an approval. Please read the FDA Guidance on Changes in IND Protocol:
https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-reporting-protocol-amendments

Nowhere does the FDA specify that they will provide APPROVALS to the changes -- it just requires filing of protocol changes that meet certain requirements.