So when we give something a biologics license, we are really saying that we have a lot of confidence in that product, in the safety, efficacy and manufacturing information. Not just when it's used exactly according to how it's labeled, but potentially if it were used somewhat differently by physicians. - Peter Marks, FDA
And that is why an approval of DCVax-L will open doors for its expanded prescription for those physicians willing to prescribe it off-label for their patients’ other operable solid tumor cancers.