It won't become available until the data is unblinded.
In the double-blind trial, they cannot file for marketing approval based on ORR alone.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf 1980s, after discussion with the ODAC, the FDA determined that cancer drug approval should be based on more direct evidence of clinical benefit, such as improvement in survival, improvement in a patient’s quality of life (QOL), improved physical functioning, or improved tumor-related symptoms. These benefits may not always be predicted by, or correlate with, ORR.
If they have any hope of filing based on these trial results, what additional positive data will they have to supply to gain approval? Will they wait for PFS, even though it's not prespecified as an endpoint, before unblinding the data...? Will they try to use the open label trial data to argue clinical benefit? Can they use previous trials to support this filing if the trial protocols are different? (IIRC, this is the first trial using Docetaxol.)
I think they're going to be very careful to dot all Is and cross all Ts before unblinding the data.
FWIW
Just looked at your slide. They may not wait for PFS, but what biostatistical validity will it have if the data has already been unblinded?
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