he scrutiny of data appears to have included not only that for the phase 1/2 glioblastoma trials of 20 newly diagnosed GBM patients who received DCVax-L but also patients given the drug in the phase 1/2 prostate cancer and phase 1/2 ovarian cancer trials as well as patients treated with compassionate use.
The Section 4b exemption was implemented in the German drug laws in July 2011. The approval for DCVax-L is the first such approval granted by the German regulatory authorities in multiple key ways. Only two prior approvals have been given in the more than 2-1/2 years since the law was put in place, and those were for two German companies with tissue engineered products which had already been on the market commercially under prior laws and were grandfathered for regulatory purposes, and which did not have pharmacological (i.e., drug-like) effects in the patient’s body.
The last approvals that the Germany government gave were 2 1/2 years ago and they went to German drug companies. This is a huge for the company and the efficacy of DCVAX-L. Germany is top country for new drugs. Wake up folks we have a first immunotherapy drug. Congrats to Longs .
I believe this is the biggest cross border regulatory "tell" i have seen in the last 30 years.
German regulators or tough and this greatly increases the probability of early DMCB stop on efficacy leading to early approval by the FDA.