Can someone explain what is done between the Primary and Study Completion Dates that takes 4 years to do?
The time difference is usually due to secondary measures. Galera probably wants to see if GC4419 inhibits tumor growth and hence improves survival time and has included survival analysis in secondary measures. Waiting sufficient number of people to die takes a long time. Cancer study part does not prevent Galera from filing for SOM after SOM related studies are done.
Primary completion date The date on which the last participant in a clinical study was examined or received an interventionto collect final data for the primary outcomemeasure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures.The "estimated"primarycompletion date is the date that the researchers think will be theprimarycompletion datefor the study.
Study completion date The date on which the last participant in a clinical study was examined or received an intervention/treatmentto collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit).The "estimated"studycompletion date is the date that the researchers think will be thestudycompletion date.