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  • Northwest Biotherapeutics: Capital Raise Of $35 Million Could Be A Positive Catalyst For The Stock
    Thu, Nov. 20 NWBO 28 Comments

    Summary

    • Neil Woodford, a highly respected UK portfolio manager has just invested $25 million on very favorable terms and the Company has also received $10 million from a mortgage financing.
    • This takes away the near term concern about financing that has been a lid on the stock.
    • There is now a cash runway to see the Company through to the release of phase 3 results on DCVax-L in 2H, 2015 and completion of phase 1 DCVax Direct.
    • I see this as a significant catalyst for the stock.
  • Celldex Therapeutics: Interim Results For Phase 2 ReACT Trial Are Very Encouraging
    Mon, Nov. 17 CLDX 17 Comments

    Summary

    • This was a phase 2 trial in 72 recurrent glioblastoma patients randomized to 35 on rindopepimut plus Avastin versus 37 on Avastin.
    • Rindopepimut showed a survival advantage of 3.2 months.
    • Celldex will ask the FDA to consider this data as sufficient for approval in recurrent GBM. I think the FDA will agree.
    • This data bodes well for the phase 3 ACT IV trial in nwly diagosed GBM which should report topline data in mid-2015.
  • Cytokinetics Is Planning New Phase 3 Trial For Tirasemtiv In ALS Using New Endpoint
    Mon, Oct. 20 CYTK 17 Comments

    Summary

    • Cytokinetics announced that it is planning a new phase 3 trial for tirasemtiv in 2015 using sustained vital capacity as the primary endpoint.
    • I think that the trial will only go forward if the FDA agrees to a Special Protocol Assessment using this measure as an endpoint.
    • If the FDA does not agree to a Special Protocol Assessment, I think tirasemtiv will be dropped from clinical development.
    • This renews hope that tirasemtiv could be approved for ALS in the future. There seems to be no expectation of this in a stock price in the mid $3.00s.
  • Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party
    Fri, Oct. 17 DSCO 26 Comments

    Summary

    • This agreement partners Discovery with a world class medical device developer and meaningfully de-risks development of Aerosurf.
    • It also gives meaningful validation from a sophisticated third party of the revolutionary potential for Aerosurf in treating respiratory distress syndrome.
    • The terms of the collaboration reduces capital needs for Discovery and Battelle only wins if Aerosurf is successfully developed.
    • Phase 2a Aerosurf results will be reported in 4Q, 2014. These relate primarily to safety and may not have any efficacy signal. They may not affect the stock price.
    • Phase 2b results should be available in 4Q, 2015. Positive results would be the first proof of concept in a controlled trial and would be very positive for the stock.
  • Northwest Biotherapeutics: U.K. May Grant Early Patient Access For DCVax-L Prior To Formal Approval
    Thu, Sep. 18 NWBO 16 Comments

    Summary

    • UK designates DCVax-L as first drug to be considered for early access approval under recently enacted EAMS program.
    • Earlier this year, Germany granted approval to DCVax-L under its early access program.
    • Early access means that DCVax-L can be prescribed prior to formal approval that might come in 2016. I expect revenues from German sales in 2014.
    • These actions by regulatory agencies are unsurpassed validation for the potential of the DCVax-L technology, in my opinion.
    • On another positive note, the phase 2 trial of DCVax Direct should begin in 4Q, 2014.
  • ImmunoCellular: Thoughts On Management's Plan To Move ICT-107 Into Phase 3
    Tue, Sep. 9 IMUC 15 Comments

    Summary

    • Management hopes to begin a Phase 3 trial in a subgroup of patients who are HLA-A2 positive, possibly in 1H, 2015. It might conclude in late 2018 or 2019.
    • I estimate that HLA-A2 sub-group is 34% to 40% of the 3,500 newly diagnosed GBM patients annually in the US.
    • I estimate the price of ICT-107, if approved, would be $150,000 per treatment or more, which is in line with the price point of the newly introduced anti-PD-1 drugs.
    • I agree that ICT-107 should be taken forward based on the data.
    • However, I think that others are less optimistic and it may be very difficult for IMUC to raise the capital needed to fund the trial. Hence, I am neutral.
  • Antares: An Analysis Of FDA Briefing Documents For September 17th Advisory Committee Meeting On Testosterone Replacement Products
    Thu, Sep. 4 ATRS 19 Comments

    Summary

    • The FDA does not appear to be concerned about cardiovascular risk with testosterone replacement products so this is a major positive.
    • The FDA is asking the panel to consider if these products are used too much in unapproved indications.
    • The testosterone replacement market has shrunk significantly in 2014 due to the cardiovascular safety issue. There could be continued shrinkage in 2015.
    • This market is not going away. I see opportunity for Antares’ QST accounting for $50+ millions of product sales by the end of the decade.
    • QST is a major product opportunity for Antares and I remain a buyer.
  • Cytokinetics: Will The FDA Agree To A New Phase 3 Trial For Tirasemtiv?
    Wed, Sep. 3 CYTK 10 Comments

    Summary

    • Tirasemtiv failed to reach the primary endpoint of ALSFRS-r in the Phase 2b BENEFIT-ALS trial, causing investors to write off any potential for the drug.
    • I believe that Cytokinetics will attempt to persuade the FDA and EMEA to accept sustained vital capacity as the primary endpoint in a new Phase 3 trial.
    • If the agencies agree to SVC as a primary endpoint, I think there is a high probability for success. If not, I think Cytokinetics will abandon development of tirasemtiv.
    • Because expectations are so low for tirasemtiv, there is asymmetric upside potential if a Phase 3 trial is undertaken and is successful.
  • Northwest Bio: The Data Monitoring Committee Addresses The Status Of The DCVax-L Trial
    Wed, Aug. 13 NWBO 225 Comments

    Summary

    • 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
    Thu, Jul. 17 NWBO 82 Comments

    Summary

    • 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
    Fri, Jun. 13 DSCO 12 Comments

    Summary

    • 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
    Editors' Pick • Mon, Jun. 2 IMUC 32 Comments

    Summary

    • 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
    Wed, May. 28 NWBO 157 Comments

    Summary

    • 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
    Thu, May. 15 NWBO 48 Comments

    Summary

    • 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
    Fri, May. 2 DSCI 10 Comments

    Summary

    • 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
    Thu, Apr. 3 NWBO 304 Comments

    Summary

    • 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
    Sat, Mar. 15 CMRX 7 Comments

    Summary

    • 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
    Editors' Pick • Tue, Mar. 11 NWBO 60 Comments

    Summary

    • 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
    Editors' Pick • Thu, Feb. 20 AGEN 20 Comments
  • Cytokinetics: Institutional Investors Give BENEFIT-ALS Potential Results A Vote Of Confidence
    Thu, Feb. 20 CYTK 32 Comments
  • Derma Sciences: A Not Well Followed Growth Company With Solutions For Diabetic Foot Ulcers
    Wed, Feb. 19 DSCI 4 Comments
  • Cadence: What To Do With The Proceeds And A Post Mortem On A Successful Investment
    Thu, Feb. 13 MNK 18 Comments
  • Cadence: Patent Settlement With Sandoz Increases Confidence That Ofirmev Will Have Exclusivity Through December 6, 2020
    Fri, Jan. 31 MNK 2 Comments
  • Neuralstem: Sizing Up Potential Key Events Of 2014
    Tue, Jan. 28 CUR 22 Comments
  • Agenus: Key Opinion Leader Support Builds For Prophage
    Tue, Jan. 21 AGEN 45 Comments
  • Highlights Of Recent PSivida Presentation
    Sun, Jan. 12 PSDV 3 Comments
  • Thoughts On The Price Surge Of Cytokinetics
    Sun, Jan. 12 CYTK 9 Comments
  • Senesco Offers A New Approach To Cancer Treatment And Dr. Phillip Frost Is Now With The Company
    Editors' Pick • Wed, Jan. 8 SVON 16 Comments
  • Celldex: Some Thoughts On Rindopepimut
    Editors' Pick • Dec. 19, 2013 CLDX 12 Comments
  • PSivida: Game On
    Dec. 19, 2013 PSDV 10 Comments
  • Agenus: How Meaningful Is The Prophage Phase II Data?
    Dec. 17, 2013 AGEN 16 Comments
  • ImmunoCellular: Post Hoc Analysis Of Disappointing Phase II Trial Of ICT-107
    Dec. 16, 2013 IMUC 234 Comments