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News Breaks
March 10, 2014
08:13 EDTNWBONorthwest Biotherapeutics announces two German approvals
Northwest Biotherapeutics announced that it has received approval from the Paul Ehrlich Institute of a "Hospital Exemption" early access program under Section 4b of the German Drug Law. Under this Hospital Exemption, NW Bio may provide DCVax-L to patients for the treatment of any glioma brain cancers, both newly diagnosed and recurrent, outside of the company's clinical trial and charge full price. The patients may be from Germany or elsewhere. This approval has a term of five years, and can be re-applied for and re-issued at the end of that period. DCVax-L products that are to be covered by the Hospital Exemption in Germany must be manufactured in Germany, but can be administered to patients from anywhere. As in the company's clinical trial, DCVax-L will be administered under the Hospital Exemption as an adjuvant treatment after surgical removal of the tumor and radiation/chemotherapy where applicable. The company will provide annual data reports to the German regulatory authority during the five-year term of the Hospital Exemption. The company expects to activate this program over the coming months.
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August 21, 2015
15:26 EDTNWBONorthwest Biotherapeutics confirms Phase 3 trial of DCVax-L is ongoing
Northwest Biotherapeutics confirmed that its Phase III trial of DCVax-L for newly diagnosed glioblastoma multiforme is ongoing and the patients enrolled in the trial are continuing to be treated per the protocol. Over 300 patients have been recruited for the trial. The total anticipated enrollment is 348 patients. The only change in status of the trial is that new screening of patient candidates for the trial has been temporarily suspended while the company submits certain information from the trial for regulatory review. Such screening involves the initial evaluation of patient candidates to determine whether they meet eligibility criteria for the trial. Some blogs and social media comments have noted that the EudraCT trials database in Europe states that there is a "Temporary Halt" of the trial in Germany. In actuality, the trial status in Germany is that the trial is ongoing as noted above, and the company has only undertaken a temporary suspension of new screening. The company has sought to have the EudraCT listing corrected, but the database includes only certain pre-specified categories and there is no category that corresponds to a temporary suspension of new screening only, while a trial is ongoing. The company is in the process of preparing the trial information for regulatory review and anticipates submission within the next couple of weeks.
12:49 EDTNWBONorthwest Bio stops screening new patients in DCVax-L study, Reuters reports
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09:13 EDTNWBOOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Accuray (ARAY), up 12.7%... Brocade (BRCD), up 6%... salesforce.com (CRM), up 3.5%. DOWN AFTER EARNINGS: Intuit (INTU), down 6.7%... Deere (DE), down 5.4%... Nordson (NDSN), down 4.4%. ALSO LOWER: GigOptix (GIG), down 20% after 9.22M share Spot Secondary priced at $1.70... VirnetX Holding (VHC), down 19.8% after filing to sell 35M shares of common stock... Northwest Biotherapeutics (NWBO), down 8.7% after TheStreet's Adam Feuerstein reports, via Twitter, that CVax Phase 3 study has been temporarily halted in Germany.
08:49 EDTNWBONorthwest Phase 3 study halted in Germany TheStreet's Feuerstein says
The European Union Clinical Trials Register says Northwest Biotherapeutics' DCVax Phase 3 study has been "temporarily halted" in Germany, TheStreet's Adam Feuerstein reports via Twitter. Shares of Northwest are down 63c to $8.25 in pre-market trading.

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