AF and his associates have shorted NWBO when it was traded above $5, since NWBO will have about $27.6 million of cash at the end of 2013 (this includes a $5.5 million grant from the German government for partial funding of the DCVax-L phase III trial in Germany). I also estimate that the effective debt will be about $4.3 million (this is primarily accounts payable related to clinical trials enrollment). This $27.6 million of cash and $4.3 million of debt compares to $37 thousand of cash and $52 million of debt at the end of 2011. NWBO has dramatically restructured its balance sheet without flooding the market with stock and warrants.
NWBO has 64 million fully diluted shares having drugs in phase III development and important topline results due 2014 this was a right time to pickup at cheap with misleading PR......
NW Bio also has orphan drug status granted in both the US and Europe for DCVax-L for GBM
and other glioma brain cancers. The orphan drug laws grant 7 years of market exclusivity in the
US and 10 years of market exclusivity in Europe for products that are the first of their type to
reach the market. Such market exclusivity could apply to NW Bio’s DCVax-L. If so, the scope
could be broad: for treatment with DCVax-L, there are no limitations based on either tumor
characteristics or patient characteristics. Generally, any GBM patient can be treated with
DCVax-L if their immune cells are adequate and just 2-3 grams of their tumor tissue (roughly
similar in size to one sugar cube) can be obtained, to provide the antigens for the product.
“At NW Bio we have worked long and hard, and without major fanfare, to develop our
technology, our robust clinical trial designs, and our many chances for success through multiple
programs on two continents,” commented Linda Powers, CEO of NW Bio. “Although there are
never any guarantees of successful results in clinical trials, we hope to deliver strong results for
both patients and investors through one or more of our multiple programs.”
Dr. Andrew Sloan, Peter D. Cristal Chair of Neurosurgical Oncology at Case Western Reserve School of Medicine, discusses the DC-Vax technology and the promising clinical data seen to-date.
As is normally the case, this interim analysis of the Company's Phase III trial data is being conducted by an independent Data Monitoring Committee (DMC), with assistance from the independent CRO (contract research organization) managing the trial. The independent CRO audits and confirms the raw data, and delivers it to the DMC. The DMC then reviews and evaluates the data and reaches an assessment, which it delivers to the Company. The most common DMC recommendation is to continue the trial as originally planned, although it is possible in rare instances that the DMC may recommend that the trial be stopped, either because of safety or futility concerns or because of unexpectedly high levels of success. The Company does not participate in the interim analysis process or the assessment, and both the Company and the clinical trial sites remain completely blinded.
Due to the work involved in auditing and preparing the data, and conducting the review, it is anticipated that the DMC may complete its evaluation and recommendation approximately six to eight weeks from now.
Northwest Biotherapeutics announced that the number of events required to trigger the first interim analysis of its Phase III clinical trial in patients with Glioblastoma multiforme brain cancer has been reached
Recently, GlaxoSmithKline (GSK) successfully developed the first malaria vaccine, RTS,S, which will be able to prevent children from contracting malaria and other malaria-related diseases. GlaxoSmithKline, in collaboration with Agenus (AGEN), will develop this vaccine.
R&D funding and base for market selection
For its R&D and to run its trial studies, GlaxoSmithKline received around $200 million from the Bill & Melinda Gates Foundation, which contributed its financial, scientific, and managerial expertise to develop RTS,S more efficient. It has invested around $350 million to date and is planning to invest another $260 million to develop RTS,S as a complete vaccine to prevent malaria in young children and infants.
To evaluate the efficiency of its RTS,S malaria vaccine, GlaxoSmithKline is working with 11 African research centers in seven African countries. The company selected the African countries for its trial studies because malaria claims around 660,000 lives every year, mostly in sub-Sahara Africa. GlaxoSmithKline, with its research centers, took all initiatives for overall development of this vaccine, and it is focusing on making it more effective in preventing this dangerous disease in children. With all these efforts, the company was able to attain superior efficacy and safety endpoint in its trial phases
GSK’s plans to submit a regulatory application in 2014 for a Scientific Opinion of the European Medicines Agency (EMA) on RTS,S safety, efficacy and quality. If the EMA give a positive opinion, and there is satisfactory public health information from the Phase 3 program, the World Health Organization has indicated that a policy recommendation for the RTS,S malaria vaccine candidate is possible in 2015, paving the way for potential decisions by African nations for large-scale implementation of the vaccine through their national immunization programs.
Remember it is outstanding results and CLDX is an example in front for what investors thinks during PH-III.
Agenus plans to discuss a late-stage trial with the U.S. Food and Drug Administration, based on the trial data.
A preliminary analysis of the study in May had showed that the vaccine had a 146 percent increase in progression-free survival when compared with the standard-of-care.
"We are impressed by the data and look forward to feedback from the FDA regarding next steps," Roth Capital Partners analyst Joseph Pantginis wrote in a note, raising the price target on the stock to $15.
Bottom line is Option exercised as to TIMMING TO BUY ! and NOT WAIT.
Monday, September 23, 2013 at 12 noon ET
Andrew T. Parsa, MD, PhD, Michael J. Marchese Professor and Chair, Department of Neurological Surgery at Northwestern University School of Medicine;
John A. Boockvar, MD, Professor of Neurological Surgery and Co-director of the Brain and Spinal Tumor Program at the Weill Cornell Brain and Spine Center.
The overwhelmingly most important vote of confidence in the drug comes from the National Cancer Institute that is funding almost all of the expense in an ongoing phase II trial of Prophage in recurrent glioblastoma. American Brain Tumor Association.
AGEN is NASDAQ listed not OTC company. AGEN is monitored and controlled by SEC antitrust regulations, it's not a game announcement as AF indicated.