RE:Bear , in response to Carpe you say...Fuzzy,
Phase 3 BETonMACE is a smallish trial of only ~2400 patients and somewhere in the ballpark of 3600 to 4000 patient years. From what Resverlogix has communicated, both the EMA and FDA seem on board for path to approval with just Phase 3 BETonMACE. However, because of the limited number of patients and trials conducted by Resverlogix for apabetalone, there may be addiitonal follow up trials (hopefully after initial approval) to show LONG term safety in a LARGE number of patients. 2400 patients for median dosing of about 2 years is a small population and short duration.
Phase IV is pretty clean cut. From the
AHA. "
Phase IV trials track additional information about an experimental drug or treatment's safety and optimal use after it has been approved by the FDA and made available to the public."
I don't know as much about Phase 3b trials.
One description I read describes it as "
Phase IIIb: Clinical trials conducted after regulatory submission of an NDA or other dossier, but prior to the medicine's approval and launch. These trials may
supplement earlier trials, complete earlier trials, or may be directed toward new
types of trials (e.g., quality of life, marketing) or Phase IV evaluations. This is the
period between submission and approval of a regulatory dossier for marketing
authorization." Another Phase 3b description states "
A subcategory of a Phase-3 clinical trial, performed near the time of approval to accumulate additional findings which and may be required as a condition of regulatory authority approval. Dossier review may continue while associated Phase-3B trials are conducted."
BearDownAZ