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Northwest Biotherapeutics (OTCQB: NWBO) one of the most exciting stocks trading on the bulletin boards today, is a heavily shorted biotech that recently reported positive top-line results from its phase 3 trial on DCVax®-L for Glioblastoma, the most aggressive type of brain cancer representing a a potential market expected to reach $1.4 billion by 2025. DCVax®-L has succeeded where well over 400 clinical trials for glioblastoma having failed and its highly effective. In the recent Phase 3 clinical trial both median survival and the “long tail” of extended survival were significantly increased in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax®-L. Investors sentiment is high as countless medical professionals and Doctors have gotten behind DCVax®-L who believe the approval by the MHRA is imminent.
The shorts are trying to mislead investors on too that recently posting a fake MHRA complaint online. According to Fintech there are currently 39 million shares short of NWBO. In December the Company filed a lawsuit in Manhattan alleging Citadel Securities, Susquehanna and “other Wall Street firms drove down the price of NWBO through a series of illicit trading tactics.” It also includes Canaccord Genuity, G1 Execution Services, GTS Securities, Instinet, Lime Trading and Virtu Americas.
The next big step for Northwest bio is the submission of the marketing application to the MRHA in the UK. The MHRA has made DCVax a top priority to review and the review process could move forward very quickly if NWBO utilizes the rolling review submission process. Revenue just in the UK for GBM will be at least $200 million per year.
Northwest Bio has built a manufacturing facility in Sawston, UK spanning a total of 88,345 square feet on two floors and initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually.
Production of the first NW Bio dendritic cell cancer vaccine for a compassionate use patient at the licensed production facility in Sawston started a while ago. Since the issuance of the MHRA licence, Advent Bioservices has been conducting the required post-approval re-validations and testing, and the facility is now ready to scale up the manufacture of cell therapy products for clinical use.
On November 17 NWBO reported that in its Phase III clinical trial both median survival and the “long tail” of extended survival were increased in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax®-L. The trial has met both the primary and the secondary endpoint under the Statistical Analysis Plan for the trial. The trial results were reported today in a featured publication co-authored by more than 70 physicians from leading institutions across the U.S., Canada, U.K. and Germany, in the peer reviewed cancer journal JAMA Oncology, entitled “Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination with Extension of Survival Among Patients with Newly Diagnosed and Recurrent Glioblastoma”.
The Company believes this is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma, and the first time in nearly 30 years that a Phase III trial of any type of treatment has shown such survival extension in recurrent glioblastoma.
Glioblastoma is the most common and most lethal form of primary brain cancer. Standard of care (SOC) treatments have been virtually unchanged for nearly 20 years. With SOC treatments, patients typically survive for only about 15-17 months from diagnosis, with the tumor recurring at about 6-8 months from diagnosis and the patients typically surviving for about 7-9 months after recurrence. Five-year survival from diagnosis is only about 5%.
NWBO has an enormous following of investors, many of them medical professionals who are passionate in their support of DCVax®-L and its ability to completely disrupt the global market for Glioblastoma worth billions starting in the UK where MHRA approval is expected to come in 2023 and then on to the EME, a much larger market, which is believed the best way for eventual approval in the USA.
Disclosure: we hold no position in NWBO either long or short and we have not been compensated for this article.
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