|By PR Newswire||
|March 12, 2014 11:22 PM EDT||
BETHESDA, Maryland, March 13, 2014 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today refuted what the Company strongly believes are false statements and material distortions made by Adam Feuerstein in an article on Tuesday, March 11.
Feuerstein accused NW Bio of manipulating its news by delaying announcement of the Hospital Exemption approval by the Paul Ehrlich Institute ("PEI," the FDA of Germany). The Company strongly believes that Feuerstein's accusations were factually wrong, materially misleading and reflect a lack of knowledge on Feuerstein's part in regard to the German procedures and legal requirements relating to the PEI decision and the Company's announcement.
Feuerstein noted that the PEI decision was delivered to the Company on Friday, February 21. What Feuerstein failed to note was that the quite lengthy PEI decision document was delivered to the Company entirely in German. Due to the length and technical nature of the document, it required more than a week for the Company to receive the English translation. The Company then had to obtain confirmation of the accuracy of the translation, and obtained confirmations about certain provisions of the approval. This process took several days.
Finally, under the applicable German regulations, before the Company was permitted to issue its announcement, the Company was legally required to obtain approval of the full text of the Company's announcement by an Information Officer in Germany who had been designated as required by the PEI. The approval of the independent German Information Officer was provided to the Company at the end of the day German time, mid-day U.S time, on Friday, March 7. The Company then proceeded with issuance of the announcement on Monday morning, March 10.
The Company strongly believes that the only manipulation that has occurred in this case is Feuerstein's use of the date of just the first step in the multi-step process to make what the Company believes was a serious distortion of the facts about NW Bio's announcement and its timing.
Feuerstein's article also raised assorted additional other negative claims relating to the Company's clinical trial program which the Company strongly believes are baseless and seriously misleading. The Company reiterates that its Phase III trial is on track, and it refutes those Feuerstein claims as well.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company's lead program is a 312-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." The Company is under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers, with a primary efficacy endpoint of tumor regression. The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer. The Company conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania.
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "design," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company's ability to raise additional capital, risks related to the Company's ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company's products will demonstrate safety and efficacy, risks related to the Company's and Cognate's abilities to carry out the intended manufacturing expansions contemplated in the Cognate Agreements, risks related to the Company's ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing. Additional information on these and other factors, including Risk Factors, which could affect the Company's results, is included in its Securities and Exchange Commission ("SEC") filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
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