Avid Bioservices Inc (CDMO)

[investingdog]

Let's take a closer look at that trial.


This is what we know:

Estimated Enrollment: 86
Study Start Date: June 2010
Enrollment completed: Sep 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Completion date has been postponed several times, originally they expected completion by mid 2012.
SOC in this trial is carboplatin and paclitaxel
MOS for front line stage IIIB/IV non-squamous is 10.3 months
MOS in single arm previous SOC+BAVI front line NSCLC was 12.4 months (including squamous).


This is what we can guess:

They estimated the original completion date of June 2012 based on the enrollment schedule and expected MOS for SOC and MOS for SOC+Bavi using some predefined trigger point


What has changed? Three possibilities:

1. Patients in both arms living a lot longer than historical data
2. Only patients in Bavi arm are living a lot longer
3. They decided to change trigger point from ~60% to ~80%+ to catch more of the tail end separation


Question I have:

Do we know what is trigger point and can they arbitrarily change the trigger point during trial.