Northwest Biotherapeutics: U.K. May Grant Early Patient Access For DCVax-L Prior To Formal Approval
- UK designates DCVax-L as first drug to be considered for early access approval under recently enacted EAMS program.
- Earlier this year, Germany granted approval to DCVax-L under its early access program.
- Early access means that DCVax-L can be prescribed prior to formal approval that might come in 2016. I expect revenues from German sales in 2014.
- These actions by regulatory agencies are unsurpassed validation for the potential of the DCVax-L technology, in my opinion.
- On another positive note, the phase 2 trial of DCVax Direct should begin in 4Q, 2014.