March 13, 2014
Northwest Biotherapeutics, 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 Germanywho 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.
See the press release here.