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Northwest Bio: The Data Monitoring Committee Addresses The Status Of The DCVax-L Trial
- Chairman of DMC says that there has not yet been an interim analysis performed for efficacy in the phase 3 trial of DCVax-L.
- He says that NWBO is totally blinded to the data and has no idea of how results are trending.
- This is a serious blow to the bear thesis that maintains that the interim analysis had been performed, the results were bad and that NWBO hid the results from investors.
Northwest Biotherapeutics: Responding To Richard Pearson's Article Alleging A Promotion Scheme
- I categorically deny all charges that Pearson has raised in his article that I engaged in the promotion of NWBO or any other company.
- I categorically deny that I received any compensation to write about NWBO, or any other company.
- Pearson presents only circumstantial arguments to support his case. I have asked Pearson for objective evidence that I have been paid to write on companies.
Discovery Laboratories: Surfaxin Launch Has Been Slow, But Clinical Trials Of Aerosurf Are Beginning At Last
- The Surfaxin launch has been slow, and analysts' expectations are for $2 million of sales in 2014.
- The potential for Aerosurf to become a blockbuster in neonatology is the key issue for the stock.
- Phase IIa results for Aerosurf are due in 3Q 2014, and Phase IIb proof-of-concept results could be available in 4Q 2015.
ImmunoCellular Plans To Move ICT-107 Forward Into Phase III Trials Based On New Sub-Group Analysis Presented At ASCO
- IMUC has identified two prospectively defined sub-groups of patients based on HLA-A2 and MGMT status that show encouraging results in GBM.
- The company plans to speak to regulatory agencies and move forward into Phase III trials.
- These two sub-groups comprise about 31% of GBM patients.
Northwest Biotherapeutics: Management Discusses Interim Data On Phase I/II Trial Of DCVax-Direct
- Interim results are for 19 patients who received two weeks of treatment; the protocol calls for 8 months of treatment.
- Early results indicate that 11 patients have shown tumor necrosis and an immunological effect on the tumor.
- Six patients have shown tumor shrinkage or stable disease, with one patient showing tumor shrinkage of 28%, just short of 30% which qualifies as a partial response.
- The key is whether these early responses translate into complete or partial responses as patients progress through the next 7 1/2 months of treatment.
Northwest Biotherapeutics Reports On Sarcoma Patient Treated With DCVAx-Direct
- NWBO provides information on sarcoma patient treated with DCVax-Direct.
- This is the first report on any patient treated with DCVax-Direct.
- The data is limited and early, but still quite encouraging.
Ed Quilty, CEO Of Derma Sciences, Outlines His Strategy To Build A Premier Wound Healing Company
- DSCI is a pure play investment opportunity for the treatment of diabetic foot ulcers; the incidence for which is about 1.2 million cases per year.
- DSCI's products are applicable to 300,000 to 500,000 cases which develop into serious conditions for which the treatment cost is $20,000 to $40,000.
- Its Advanced Wound Care Products are projected to have sales of $45 in 2014 and are growing at 30% per year justifying much of the current $280 million market capitalization.
- There is not much in the stock price for DSC-127, a potential blockbuster drug in phase 3 that will report data in mid-2015.
Refuting The Latest Negative Blog On Northwest Biotherapeutics
- There is no previously undisclosed new information in the risk factors section of NWBO's 2013 10-K.
- Progression free survival is a solid primary endpoint for DCVax-L phase 3.
- NWBO management states that it is confident that the design of the phase 3 trial of DCVax-L, if successful, is properly and robustly designed to achieve regulatory approval.
Chimerix: A Company Focused On Infectious Viral Diseases With Investment Characteristics Similar To Trius
- CMRX's brincidofovir is a novel anti-viral drug for preventing cytomegalovirus infections in hematopoeitc cell transplant patients.
- There is no drug approved for this indication.
- Cytomegalovirus infections can result in graft rejection, hospitilizations and death.
- I think that brincidofovir could gain approval in 2016 and my model projects potential sales of $800 million by 2021.
Analysis: Northwest Biotherapeutics DCVax-L Germany Approval Under Hospital Exemption Early Access Program
- DCVax-L gains approval in Germany through new (two years old) hospital exemption early access program.
- Approval is for all forms of glioma not just glioblastoma multiforme, both newly diagnosed and recurrent.
- This is first systemic drug approved through this new regulatory process. It is a great coup for management.
- Please read this report very carefully, this is a new and unprecedented investment situation.
- Agenus: Acquisition Of 4-Antibody Is A Transformational Move
- Cytokinetics: Institutional Investors Give BENEFIT-ALS Potential Results A Vote Of Confidence
- Derma Sciences: A Not Well Followed Growth Company With Solutions For Diabetic Foot Ulcers
- Cadence: What To Do With The Proceeds And A Post Mortem On A Successful Investment
- Cadence: Patent Settlement With Sandoz Increases Confidence That Ofirmev Will Have Exclusivity Through December 6, 2020
- Neuralstem: Sizing Up Potential Key Events Of 2014
- Agenus: Key Opinion Leader Support Builds For Prophage
- Highlights Of Recent PSivida Presentation
- Thoughts On The Price Surge Of Cytokinetics
- Senesco Offers A New Approach To Cancer Treatment And Dr. Phillip Frost Is Now With The Company
- Celldex: Some Thoughts On Rindopepimut
- PSivida: Game On
- Agenus: How Meaningful Is The Prophage Phase II Data?
- ImmunoCellular: Post Hoc Analysis Of Disappointing Phase II Trial Of ICT-107
- Northwest Biotherapeutics: An Analysis Of Its Transforming Balance Sheet Restructuring
- Repligen - My Projections For The Income Statement: 2013-2019
- Celldex: Tune In For Monday's Conference Call On Rindopepimut
- Cadence: Best Case Outcome On Ofirmev Patent Litigation
- Antares Marketing Agreement With Leo On Otrexup Is A Nice Positive
- Discovery Laboratories: Removal Of Financing Overhang A Catalyst For The Stock
- ImmunoCellular: Thoughts On Potential Outcomes For The Phase II Trial Of ICT-107
- Antares: Thoughts On The Upcoming Otrexup Launch