NorthWest Biotherapeutics Inc (NWBO)

[gnawkz]

According the American Cancer Association ...

http://www.cancer.org/treatment/treatmentsandsideeffects/clinicaltrials/compassionate-drug-use

The following quote:

A company sponsoring a drug in the late stages of drug development, such as Phase III clinical trials, can offer expanded access programs for patients who are not able to enroll in a clinical trial. (See Clinical Trials: What You Need to Know to learn more about the phases of clinical trials.)

The FDA generally approves these EAPs if the drug has shown that it works at least somewhat to treat cancer in the clinical trials that are being done. This can allow a lot of people access to the unapproved drug, as long as they meet the requirements of the EAP.

Since DCVax-L was recently approved for a 99 patient EAP, I believe it is another piece of evidence that FDA has been exposed to data from the first interim analysis of DCVax-L AND that it shows some form of efficacy.