Avid Bioservices Inc (CDMO)

[Thurly]

The protocol lists a single Primary Outcome Measure: ORR. But it specifies the timeframe as Until Disease Progression. It appears that the data will not be unblinded until the PFS data point is reached.

On ClinicalTrials.gov, the company estimates the Primary Completion Date to be April 2012 and the Study Completion Date to be June 2012.

That pretty much accords with your statement:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=72266356
Hopefully the median PFS data would be released by the end of May...

Since the data won't be unblinded until the PFS data point is reached, doesn't that mean that the ORR numbers won't be released before the PFS numbers?

That's a long-winded way to argue that, for a timeline: ORR and PFS data will be released together in late May or sometime in June.

Separately...

Since PFS data will be calculated from the blinded data once unblinded, doesn't that preserve the possibility of an ammended protocol where PFS is specified as a primary or secondary endpoint prior to unblinding? AFAIK, there is no statistical penalty for ammending the protocol prior to unblinding.

It's speculation, but assuming they want a shot of AA, no matter how remote, wouldn't it behoove them to preserve the possibility of generating stat. sig. PFS data?

I'm thinking that they have a good notion of what to expect (bavi is well enough characterized) based on the two earlier NSCLC trials. Based on how long the double-blind period goes, they should have a good notion of whether or not they're in the ballpark of stat. sig. PFS -- of whether or not they have hit a homerun.