Replies to post #5569 on Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

[EM]

Question is why an AUDIT Committee should recommend the appointment of a Data Monitoring Committee (using Waymack's words, DMC is generally an external independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing) even though it wasn't be requested by the FDA (check here https://clinicaltrials.gov/ct2/show/record/NCT02172040?term=kitov&rank=2 and search for Data Monitoring Committee).
Data Monitoring Committee was not part of the SPA protocol.