Replies to post #223263 on NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Visiting the 82 sites would be part of a different multi-month task, and would be done on the part of the CRO (contract research organization).

[CherryTree1]

The 2 processes are independent in that the SAP needs to be updated before anyone making the changes has seen the results MartyDg.

Good Review Practice:Clinical Review of Investigational New Drug Applications
Sponsors should be encouraged to include the SAP as part of the protocol, rather than providing it in a separate document, even if the SAP has not been finalized. If the SAP is changed late in the trial, particularly after the data may be available, it is critical for the sponsor to assure the FDA that anyone making such changes has been unaware of the results.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM377108.pdf