What we don't know is if the MHRA requested further information 60 days or less after 5/7/21.
reachjo Monday, 09/13/21 07:19:53 PM
Re: ae kusterer post# 401814 0
Post # of 401829
Here is what I read from the website pdf application section 4.5:
MHRA must provide a response within a total of 60 days from receipt of the original application (except for trials involving medicinal products for gene therapy, somatic cell therapy or medicinal products containing genetically modified organisms where the timeframe is 90 days). If further information is requested this should be sent to the MHRA within 14 days of the request so not to affect the 60 day timeline. All correspondence will be sent to the person named in Section C of the Clinical Trial Application form (i.e. the Chief Investigator (CI) or Sponsor’s representative) and should be filed on Q-Pulse (the Trial Master File) by the R&I Office.
Press Release
12
MAY
2021
UK Manufacturing Facility & Phase III Trial Updates From Northwest Biotherapeutics (OTCQB: NWBO)
FOR IMMEDIATE RELEASE
CONTACTS
Dave Innes
804-513-4758
dinnes@nwbio.com
Les Goldman
240-234-0059
lgoldman@nwbio.com
Application Submitted to MHRA for Certification of Sawston Facility
BETHESDA, Md., May 12, 2021 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that an application for certification of the manufacturing facility in Sawston, UK has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA). The Company also provided a process update on the DCVax®-L Phase III Trial.
On May 7, the application package was submitted to the MHRA requesting the certification of the Sawston facility to produce Good Manufacturing Practice (GMP) clinical grade medical products for patients. This application represents the culmination of more than 2 years of preparations, including more than a year conducting these efforts under challenging COVID-19 restrictions and conditions.
As previously reported on March 16, 2021, the preparations have included the physical buildout of Phase I of the facility, development of over 500 regulatory documents (including Standard Operating Procedures (SOPs) for all aspects of operations, batch manufacturing records, and other formal documents), development of a Sawston team of nearly 40 persons with all of the required types of expertise for production of Advanced Therapy Medicinal Products (ATMPs) and training in regard to the DCVax® technology and processes.
The next step will be an on-site inspection of the facility by MHRA. Following the inspection, a report of the inspection results and any findings needing any corrective action will be issued by MHRA. Following completion of any actions, the Company is hopeful that an initial license will be issued and production of GMP DCVax-L products in the Sawston facility may begin by around the end of Q3.
In addition to the MHRA submission activities, a prototype of the Flaskworks system has been delivered to the Sawston facility, and the Company currently anticipates that initial practice runs with the system may begin at the Sawston facility during the summer.
Meanwhile, manufacturing of vaccine products for compassionate use patients (“Specials”) has been and is continuing at the GMP facility in London.
The process outlined in the Company’s October 5, 2020 announcement relating to the Phase III trial of DCVax-L is continuing to move forward. The process includes review and analysis of the raw data by independent statisticians and experts, and preparation of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts in preparation for public announcement and scientific publication.
The Company continues to be in a quiet period while this process is under way. The Company appreciates shareholders’ patience, and their understanding that the Company cannot make partial disclosures during this process and cannot comment on the Phase III trial schedule or its data until the announcement of the results. We remain committed to completing the full plan outlined on October 5, 2020.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” This Phase III trial is now completed, with the trial data now being analyzed. The Company is also pursuing development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, is preparing for Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
Disclaimer
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, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our 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 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 ongoing ability to raise additional capital, and other risks included in the Company’s Securities and Exchange Commission (“SEC”) filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company’s results, is included in its 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. 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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