Biotech FAQ

How soon must a biotech release materially important information to the public?

Form 8-K is the “current report” companies must file with the SEC to announce major events that shareholders should know about. Companies have four (4) business days to file a Form 8-K for the events specified in the items in Sections 1-6 and 9 above (i.e. on the SEC page listed below).

What does an "a" or "b" mean after the clinical study phase (eg: Phase 2b)

The letter indicates it is a dose-ranging study. The sponsor is testing different drug dosages and measuring the effectiveness (and safety) of each.

Phase 2a Clinical Trials are pilot studies done on a relatively smaller number of patients (30-150) in order to judge the efficacy and safety of the investigational drug.

Whereas Phase 2b Clinical Trials are Pivotal studies, a well established controlled trails done on a larger number of patients in order to judge the efficacy and safety of the investigational drug.

Below is an example of a Phase 2a study. You can see the were trying to figure out which concentration showed the best benefit. The 40 mg dosage was best!