Presentation at the New York Academy of Sciences on Final Results of Phase 3 DCVax-L Trial Showing Impressive Efficacy (Part 3) Analyzing Hedge Fund Stock Manipulation TechniquesIntroduction This note describes why I believe that the sharp downward price movement yesterday resulted from stock manipulation by a group… Presentation at the New York Academy of Sciences on Final Results of DCVax-L Phase 3 Trial Showing Impressive Efficacy (Part 2) Incredibly Low p-Values on Median Overall Survival EndpointsEarlier today, I put out the first of a series of reports that I plan to issue on this presentation.… Presentation at the New York Academy of Sciences on Final Results of Phase 3 DCVax-L Trial Showing Impressive Efficacy (Part 1) Debunking Hedge Fund MisinformationOverview The much anticipated presentation at the New York Academy of Sciences of final results of the phase 3 trial of… Northwest Biotherapeutics: Two Lead Investigators on DCVax-L Phase 3 Trial Believe That It Could be a Major Therapeutic Advance in Treating Glioblastoma Multiforme (NWBO, Buy, $0.29)Reason for this Note I was prompted to write this note after listening to a July 2017, You Tube segment in… Northwest Biotherapeutics: Issues to Focus on in Pending Manuscript Dealing with Blinded Data from Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma (NWBO, Buy, $0.23)Purpose and Summary of This Report My key takeaway points are summarized at the end of this report. I urge you… Northwest Biotherapeutics: Thoughts on Why the Phase 3 Trial of DCVax-L is Ongoing (NWBO, BUY, $0.17)Overview The phase 3 trial of DCVax-L in newly diagnosed glioblastoma is continuing even though it has passed the 248 PFS… Northwest Biotherapeutics, Bristol-Myers Squibb: Success for the Yervoy-Opdivo Combination in CHECKMATE-214 Trial Obviously is a Major Positive for BMY, but also has Important Implications for NWBO (NWBO, Buy, $0.19) (BMY, $60.80, Buy)The stoppage at an interim analysis of Bristol-Myers Squibb’s’ CHECKMATE-214 trial provides meaningful information into assessing the potential fro success… Northwest Biotehrpeutics: How Does DCVax-L Clinical Data Compare to the CAR-T Therapy Axi-Cel? (NWBO, $0.18, Buy)New Seeking Alpha Article on Seeking Alpha An article on Seeking Alpha called Northwest Biotherapeutics: Statistically Satisfying was just published by… Northwest Biotherapeutics: Why I Believe That the Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma Patients Has a Very Good Chance for Success (NWBO, Buy, $0.17)Overview This report is an extensive update on almost everything I know about the DCVax-L phase 3 trial and is over… Northwest Biotherapeutics: Is There Any Chance for DCVax-L to be Successful in the Phase 3 Trial? (NWBO, Buy, $0.24)Acronyms Used in this Report SOC: The standard of care in newly diagnosed glioblastoma patients is surgical resection followed by… Northwest Biotherapeutics and Agenus: What Are The Implications for These Companies in the Aftermath of Two Recent Cancer Vaccine Trial Failures? (NWBO, $0.38, Buy) (AGEN, $3.99, Buy)Two Recent Cancer Vaccine Trial Failures Spurred this Report On February 22, 2017, Argos reported that the Data Monitoring Committee for… Northwest Biotherapeutics: 8-K Document Released Today Provides New and Very Interesting Data on Patients Treated with DCVax-L. (NWBO, Buy, $0.48)Substance of 8-K Regulatory Document Northwest issued an 8-K today in response to shareholders’ questions about an issue that has been… Northwest Biotherapeutics: Partial Clinical Hold on Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma is Lifted (NWBO, Buy, $0.45)Key Points: Lifting of the partial hold removes a cloud that has been overhanging the Company for the past 18… Northwest Biotherapeutics: DCVax-L Viewed Through the Eyes of Dr. Linda Liau, Lead Investigator on the Phase 3 Trial of DCVax-L (NWBO, $0.35, Buy)Principal Takeaway Messages from This Report Dr. Linda Liau believes that use of DCVax-L can result in 25% of glioblastoma patients… Northwest Biotherapeutics: Phase 2 Trial in Colorectal Cancer with Liver Metastases Announced (NWBO, Buy, $0.55)NWBO is preparing for the start of a phase 2 trial combining DCVax-L with Merck’s Keytruda in late stage colorectal cancer with… Northwest Biotherapeutics: Recent Data Update on Phase 1/2 Trial of DCVax Direct is Encouraging (NWBO, Speculative Buy, $0.43)Key Points: Data for DCVax Direct recently was updated for its phase 1/2 trial in 40 patients having 13 different… Northwest Biotherapeutics: My Hypothesis as to Why the Company Has Been Silent on Its Clinical Trial Programs and Why DCVax-L Might Succeed in its Phase 3 Trial (NWBO, Speculative Buy, $0.34)Investment Thesis I have been pretty much silent on Northwest Biotherapeutics for some time. The reason is that as an analyst… Northwest Biotherapeutics: Going Over My Thoughts (NWBO, $0.62)Overview The naming of five distinguished scientists with extensive knowledge and expertise in immune-oncology to Northwest’s scientific advisory board is the… Northwest Biotherapeutics: The Company Provides an Operations Update (NWBO, $1.23)Report Overview I usually start my reports with a summary and investment thesis. However, in this report I am putting this… Northwest Biotherapeutics: A Comprehensive Evaluation of Its Lead Product DCVax-L (NWBO, $1.50)Perspective and Overview on this Report The still unexplained and unresolved halt in screening for the phase 3 trial of DCVax-L… Northwest Biotherapeutics: Why the Failure of Celldex’s Rintega in Newly Diagnosed Glioblastoma Probably Has No Implications for the DCVax-L TrialInvestment Thesis Some subscribers have asked me if the failure of Rintega in the phase 3 ACT-IV trial in newly diagnosed… Northwest Biotherapeutics (NWBO): Some Thoughts about the Appointment of Two New Board MembersPurpose of the Report Northwest Biotherapeutics announced on January 25 that it is adding two new members to its current… Northwest Biotherapeutics: Seeking Alpha Publishes Latest in a String of Attack Articles Authored by Short Sellers (NWBO, $4.92)Seeking Alpha has published an extremely negative article by anonymous short sellers that alleges criminal misconduct on the part of management… Northwest Biotherapeutics: New Financing from Woodford was Much Needed (NWBO, $5.44)Curses, Foiled Again; The Hedge Fund’s Lament The clear intent of the recent short attack on Northwest was at a minimum… Northwest: Analysis of a Coordinated Short Selling Attack Against the Stock (NWBO, $4.69)A Suspect Plunge in Price On Friday October 16, 2015 a day in which the Dow Jones and S&P averages increased… Northwest Biotherapeutics: My Thoughts on the New Data from the Phase 1/2 Trial of DCVax Direct (NWBO, Buy, $6.91)Critical Issue in Interpreting the Data Northwest Biotherapeutics: Thoughts on Suspension of Screening of New Patients in the Phase 3 DCVax-L TrialReason for Report On August 21, Northwest put out a press release that said that screening of new patients has been… Implication of the Juno Celgene Deal for Emerging Immuno-Oncology Biotechnology Stocks in General and Northwest Biotherapeutics in ParticularThe Terms of the Juno Celgene Deal Celgene and Juno announced a ten year collaboration for drug development using CAR-T therapy… Observations from ASCO on Immuno-oncology with a Focus on Northwest Biotherapeutics’ (NWBO, Buy, $9.43) DC-Vax-Direct© and the Checkpoint Inhibitors of Bristol-Myers Squibb and MerckKey Investment Points Stemming from ASCO I have been going over data presented at ASCO on immune-oncology products and have been… Comments on Antares, Kite Pharma and Northwest BiotherapeuticsSmithOnStocks Mailbox My mailbox comments are brief articles on stocks in which I am involved. These can come from… Northwest Biotherapeutics: FDA Panel Recommendation to Approve Amgen’s Cancer Vaccine is Hugely Significant In Regard to Possible Approval of DCVax-L and DCVax Direct. (NWBO, $7.86, Buy)Overview An FDA advisory panel on April 30 recommended by a vote of 22 to 1 that Amgen’s cancer vaccine talimogene… CAR-T Companies-Kite (KITE, $55.09) and Juno (JUNO, $47.30): Is The Bloom Coming Off The Rose? Are Investor Expectations Unrealistic?Introduction to This Thought Piece Emerging biotechnology stocks obviously are very hard to value on an absolute basis because they usually… Northwest Biotherapeutics: Comments on Two AACR Posters (NWBO, $8.62, Buy)Introduction I have included an abstract on DCVax Direct and another on DCVax-L that will be presented in poster presentations at… Northwest Biotherapeutics: The $40 Million Woodford Financing is A Major Positive (NWBO, Buy, $7.76)
The $40 million will fund the Company through the end of 2015. Northwest Biotherapeutics: Highlights of the 2014 10-K (NWBO, Buy, $7.81)Introduction Northwest Biotherapeutics just issued their 10-K for 2014 and I would urge everyone to read it. The purpose of this… Northwest Biotherapeutics: How Much Will It Cost to Manufacture DCVax-L (NWBO, Buy, $7.26)There has been a lot of speculation about how much it costs to manufacture one course of individualized therapy of… Some Observations on Northwest Biotherapeutics (NWBO), Neuralstem (CUR), Cytokinetics (CYTK) and Immuno-Cellular (IMUC) from Their Presentations at BIO CEO.The BIO CEO Conference is being held in New York at the Waldorf Astoria on February 9 and 10 with… The Potentially Key Role of Northwest Biotherapeutics in the Emerging Immuno-Oncology Landscape (NWBO, Buy, $6.19)Investment Overview Linda Powers was invited to the 7th Annual Phacilitate Immunotherapy Forum in Washington D.C. to speak on the potential… Northwest Biotherapeutics: Some Thoughts about the Upcoming Presentation by CEO Linda Powers on Monday, January 26th. (NWBO, Buy, $6.28)
Ms. Powers will present at 10:30 AM. Immuno-Oncology Promises to be the Next “Big Thing” In BiotechnologyImmuno-Oncology Promises to be the Next “Big Thing” In Biotechnology Immuno-oncology has been the hottest area in biotechnology… Notes from Linda Powers Presentation in San Francisco, January 12, 2015 (NWBO, Buy, $6.00)Overview Linda Powers spoke at the Biotech Showcase Conference in San Francisco on January 12, 2015. My Buy recommendation on Northwest Biotherapeutics… Northwest Biotherapeutics: Capital Raise of $35 Million could be a Positive Catalyst for the Stock (Buy, $5.14)
Neil Woodford, a highly respected UK portfolio manager has just invested $25 million on very favorable terms and the Company… My Dialogue with Adam Feuerstein on Northwest BiotherapeuticsPerspective Northwest Biotherapeutics: Exciting News on Potential for Early Patient Access for DCVax-L in the UK
UK designates DCVax-L as first drug to be considered for early access approval under recently enacted EAMS program. Northwest Biotherapeutics: National Geographic Special Features DCVax Direct Treatment of Stage 4 Pancreatic Cancer Patient (NWBO, Buy, $5.90)
DCVax Direct was used in a patient with stage 4 pancreatic cancer whose chemotherapy was stopped. Northwest Biotherapeutics: Independent Chairman of the DMC Committee for DCVax-L Phase 3 Trial Chastises Adam Feuerstein for Inaccurate Articles (NWBO, Buy, $6.43)
The Data Monitoring Committee (DMC) is charged with monitoring the safety and efficacy results of clinical trial. The committee and… CREW Alleges That Adam Feuerstein is Involved in Stock Manipulation Scheme in Regard to Northwest BiotherapeuticsCitizens for Responsibility and Ethics in Washington (CREW) have gone after Adam Feuerstein of The Street.com. They have accused him… Northwest Biotherapeutics: Market Research Firm Evaluate Pharma Projects 2020 Worldwide Sales of $2.0 billion for DCVax-L (NWBO, Buy, $5.92)One of the basic charges made against me by Richard Pearson and other short sellers is that they maintain that… Northwest Biotherapeutics: Sixteenth Feuerstein Attack on the Company (NWBO, Buy, $8.11)Adam Feuerstein has just launched its 16th negative blog on Northwest Biotherapeutics since the beginning of March and this has… Northwest Biotherapeutics: The Perfect Storm May Be Brewing for Short Sellers (NWBO, $7.66, Buy, Free Content)I wrote on June 12th that NWBO stockholders may be seeing a changing in the tide of investor opinion. The… Northwest Biotherapeutics: The Investment Tide May be Turning Positive (NWBO, Buy, $6.41, free content)Purpose of Report This report goes over recent news on the company in regard to DCVax Direct and DCVax-L and then… Northwest Biotherapeutics: Management Discusses Interim Data on Phase 1/2 Trial of DCVax-Direct (NWBO, Buy, $6.00, free content)Introduction Northwest Biotherapeutics held a conference call on May 27th to discuss interim results of its phase 1/2, first in human,… Northwest Biotherapeutics to Host Conference Call This Afternoon, May 27th (NWBO, Buy, $6.25)
Northwest Biotherapeutics announced today that the Company will host a conference call and webcast with CEO Linda Powers today, May… Northwest Biotherapeutics Releases Promising Early Results in DCVax Direct Phase 1 Trial (NWBO, $6.20, content of this note is not limited to subscribers)Overview Northwest Biotherapeutics told investors that it would discuss initial results of the phase 1/2 trial of DCVax-Direct in inoperable solid… Northwest Biotherapeutics: Update On DCVax-Direct Based on ASCO Abstract and Positive, Early Results for First Patient Reported On (NWBO, Buy, and $5.94)Investment Conclusion The ASCO abstract on DCVax-Direct was released last night. It contains only a description of the drug and the… Thoughts on the Market Correction in Biotechnology StocksThis Has Been a Tough Correction The recent sharp market correction and rotation out of growth stocks like biotechnology and technology… Northwest Biotherapeutics: Just Announced Financing Signals High Expectations for Use of DCVax-L under German Hospital Exemption Program (NWBO, $6.75, Paid Subscribers)Purpose of New Financing Northwest Biotherapeutics just announced a financing in which a single institutional investor bought $15 million of stock… Refuting Feuerstein’s Latest Negative Blog on Northwest Biotherapeutics (NWBO, Buy, $7.56)Before I Get Into This Article, a Word to My Subscribers I want to apologize to my subscribers for a software… Northwest Biotherapeutics (NWBO, Buy, $7.59) What the 2014 10-K Had to Say about the Approval of DCVax-L under the German Early Access ProgramPurpose of This Blog The approval of DCVax-L under the hospital exemption early access program was a stunning positive in my… Northwest Biotherapeutics (NWBO, Buy, $7.90): DCVax-L Is Approved in Germany under Hospital Exemption Early Access ProgramIntroduction Please read this report very carefully. This is the first time that any systemic drug has been approved under the… Northwest Biotherapeutics (NWBO, $6.06, Buy): Comments on First Interim Look at DCVax-L Trial and Recent Weakness in the StockReason for Stock Weakness The stock of Northwest Biotherapeutics (NWBO) has been under pressure that appears largely to have been caused… SmithOnStocks Mailbox February 25, 2014I have found that there are some very smart people out there who have interesting questions and perspectives concerning my… The BIO CEO Conference: Highlights from the Meeting and New Investment Perspectives (Subscribers Only)Back From BIO CEO Conference I have returned from spending two days at the BIO CEO conference at the Waldorf Astoria… SmithOnStocks Mailbox January 28, 2014In my writing, I have found that there are some very smart people out there who have interesting questions and… San Francisco Trip Is the Basis for a Preview of 2014 (Subscribers Only)What SmithOnStocks Is All About Adam Feuerstein’s Views on Northwest Biotherapeutics (NWBO, $3.37)Adam Feuerstein has consistently disagreed with authors who believe that there is a sound basis for Northwest Biotherapeutics (NWBO) conducting… Northwest Biotherapeutics: An Analysis of Its Transforming Balance Sheet Restructuring (NWBO, $4.14)Key Takeaway Points of this Report Northwest Biotherapeutics ($3.44): M.D. Anderson’s Lead Role in DCVax Direct Trial is EncouragingNorthwest Biotherapeutics (NWBO) announced today that the phase I/II trial of DCVax Direct has been initiated at M.D. Anderson Cancer… SmithOnStocks Opines on Biotechnology Stocks, June 2, 2013Overview of This Week's Report SmithOnStocks Opines on Biotechnology Stocks, May 28, 2013Introduction Highlighting A New Report on Dendritic Cell Cancer VaccinesNorthwest Biotherapeutics’ (NWBO) DCVax-L and ImmunoCellular Therapeutics’ ICT-107 are dendritic cell cancer vaccines that are in phase II trials for… |
