tuesday - new news , page-17

gowie77
Re nwbio.com
Do you know if cvac qualifies for the same FDA benefit
as this companies lead product DCVax as shown below

The Company?s platform technology, DCVax?, uses a patient?s own dendritic cells, the starter engine of the immune system. The dendritic cells are extracted from the body, loaded with tumor biomarkers or ??antigens??, thereby creating a personalized therapeutic vaccine. Injection of these cells back into the patient initiates a potent immune response against cancer cells, resulting in delayed time to progression and prolonged survival. The Company?s lead product candidate is DCVax?-Brain which targets Glioblastoma Multiforme (??GBM??), the most lethal form of brain cancer. DCVax?-Brain has entered a Phase II FDA-allowed clinical trial, which is designed and powered as a pivotal trial (i.e. a trial from which a company may go directly to product approval). Following this trial, the Company anticipates filing a biologic license application (or ??BLA??) with the FDA for DCVax?-Brain. DCVax?-Prostate, which targets hormone independent (i.e. late stage) prostate cancer, has also been cleared by the FDA to commence a Phase III clinical trial, which is also designed and powered as a pivotal trial
Thanks in advance.