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RuleofK

10/05/17 12:15 PM

#137726 RE: beachhyena #137724

I do not know the answer to that , but I seem to recall that the number of patients under this program was 9 or 10. There was some discussion that h.e. was put on hold for new patients when the trial recruitment hold began. Somebody with a better memory or more time to research please confirm this.

flipper44

10/05/17 12:17 PM

#137727 RE: beachhyena #137724

10K covered status of Hospital Exemption:

In March 2014, we received approval from the German regulatory authority of a “Hospital Exemption” for DCVax-L for glioma brain cancers under Section 4b of the German Drug Law outside of our Phase III trial. Since then, we have undertaken program development and preparation activities, including an annual filing for a potential reimbursement score. We undertook treatment of 9 patients under the Hospital Exemption. We did not undertake new Hospital Exemption patients while the Phase III trial enrollment was on partial hold. We do not plan to undertake new Hospital Exemption patients while we complete the accumulation of data events, and analysis and reporting of the data, for the Phase III trial.
-- 10K 2016, Filed April 2017