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Replies to post #705 on Algernon Pharmaceuticals Inc (AGNPF)
01/15/17 6:17 AM
PRIMARY COMPLETION DATE
The date on which the last participant in a clinical study was examined or received an intervention and that data for the Primary Outcome Measure were collected. Whether the clinical study ended according to the protocol or was terminated does not affect this date. The "estimated primary completion date" is the date that the researchers think will be the Primary Completion Date for the study. The Primary Completion Date is the term used on ClinicalTrials.gov for "completion date" as defined in Section 801 of the Food and Drug Administration Amendments Act of 2007. (See also Primary Completion Date data element on ClinicalTrials.gov.)
PRIMARY OUTCOME MEASURE
The planned Outcome Measure in the protocol that is the most important for evaluating the effect of an intervention. Most clinical studies have one Primary Outcome Measure, but some may have more than one. (See also Primary Outcome Measure data element on ClinicalTrials.gov.)
High-risk devices (also known as Class III products) are generally assessed through the premarket approval (PMA) process, under which manufacturers must conduct at least one clinical study and submit their data for FDA review.
