Item 7.01. Regulation FD Disclosure. The Company has received a number of inquiries about rumors that are circulating alleging that the Medicines and Healthcare Products Regulatory Agency (MHRA) has made a decision on the Company’s Marketing Authorization Application (MAA) for DCVax-L for glioblastoma (GBM) and has rejected the MAA.…
Select an item to read the extracted section. The as-filed document remains the primary evidence.
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure.
The Company has received a number of
inquiries about rumors that are circulating alleging that the Medicines and Healthcare Products Regulatory Agency (MHRA) has made a
decision on the Company’s Marketing Authorization Application (MAA) for DCVax-L for glioblastoma (GBM) and has rejected the
MAA.
While the Company’s
policy of not making interim reports on the MHRA process remains in place, to address these false rumors this morning the Company requested
confirmation from MHRA of the current status of the MAA. This afternoon, the MHRA confirmed the following:
“The Marketing Authorisation
Application submitted by Northwest Biotherapeutics, Inc. for DCVax-L (for glioblastoma) remains under its initial regulatory review,
has not been refused, withdrawn or appealed, and continues to progress towards a first regulatory decision.”
The Company continues to
have constructive interactions with the MHRA, and the MAA remains under review.
The Company categorically
refutes the false rumors. The Company notes that such rumors appear to have intensified in the weeks since the Company presented at the
British Neuro-Oncology Society (BNOS) Annual Meeting significant statistical data relating to the results of its Phase 3 trial of DCVax-L
for GBM. The Company believes that the rumors appear to be accompanied by various forms stock manipulation. The Company also believes
that the rumors may be part of such manipulation as the data in the BNOS presentation were quite encouraging. The Company believes it
has seen this pattern on a number of occasions following positive developments and news.