NorthWest Biotherapeutics Inc (NWBO)

[highwayman4life]

Special protocol assesments, or SPAs, are important for every drug company, from the tiniest fleaspeck biotechnology company all the way up to Pfizer. They are agreements between a company and the FDA that a clinical trial, if conducted as planned and successful, should produce enough data for a drug to be approved. This reassures companies that they are not going to pour $40 million into a late-stage study only to have the FDA say it did the wrong trial. SPAs also ease investor fears, helping smaller companies raise money.

Unfortunately, they are treated by FDA as confidential communications between the agency and companies. What is said to investors about the SPA is entirely up the the company.

Just another example for Ex. Protocol changes, updated SAP can ALL happen as long as the sponsor is still blinded.
The FDA removed the partial clinical hold based upon agreement on revisions to the CANOVA study protocol, including new risk mitigation measures, protocol-specified guidelines and updated futility criteria. Enrollment in the CANOVA trial may resume as determined by each participant site based on the approved protocol.
https://news.abbvie.com/news/press-releases/abbvie-announces-us-fda-lifts-partial-clinical-hold-on-phase-3-study-venetoclax-in-patients-with-multiple-myeloma-positive-for-t1114-genetic-abnormality.htm