Sorry to intrude on this question Evaluate, but I wanted to expand it a bit to cover some additional points.
For an expanded access trial (other wise known as compassionate use), does the FDA takes the results of these patients into consideration?
I thought this trial was designed to provide the DCVax-L treatment to patients who did not qualify for the actual trial. If it is a compassionate use trial, would the results of the treatment be used for/against DCVax-L in the FDA approval process?
Does a compassionate use trial signal an increase in the probability for approval?