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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.
News For NWBO From The Last 14 Days
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November 25, 2015
09:35 EDTNWBOWoodford turns activist on Northwest Biotherapeutics
Woodford Investment Management transitioned from a passive investor to an active shareholder in Northwest Biotherapeutics after sending a letter to the company's board requesting an independent non-executive director be appointed. In a letter to the board disclosed last night in a regulatory filing, Neil Woodford of Woodford Investment stated, "I am writing to ask you to formally accept our proposal to appoint an independent non-executive director to the Board. As we have stated, we believe that, at your current stage of development, the Company and its shareholders would greatly benefit from the appointment of one or more directors with the skills and experience to provide significant contributions and oversight to the Company's operations and growth." Woodford has also engaged Freeh Group International Solutions to provide risk management services in relation to its investment in Northwest Bio. "These services include the provision of a suitably qualified candidate, Mr Elliott Leary, for appointment to the Company's Board. Following your agreement in principle to this proposal on 13 November, 2015, we submitted a highly qualified candidate who met with the Board last week," the letter to the board stated. Woodford explained, "We believe the candidate's skills are especially suited to the current situation of the Company in relation to the various allegations of financial improprieties and regulatory failure that have been published by at least one anonymous source. We would like to note that we only became aware of certain of these allegations after the completion of our recent investment in the Company comprising US $30 million in new equity." Woodford Investment owns 28.1% of Northwest's outstanding shares. The stock is up 5c to $5.01 in early trading.

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