Dave-Trading November 2018

*** David Sobek is a disciplined value investor.  Using models, research, and fundamental data, David devises a value for biotech stocks, buys when significantly undervalued, and sells when significantly overvalued.*** As a reminder, this is my personal guide.  You can alter it in accordance with your risk tolerance. >3 Standard deviations – No position 2-3 […]

Bria-IMT Combination Study with KEYTRUDA®: What to Know and Why

In a previous interview, BriaCell (TSX:BCT.V) (OTCQB:BCTXF) (or the Company)’s President and CEO, Dr. Bill Williams cited as a near-term catalyst data from the Company’s ongoing Phase IIa combination clinical trial of Bria-IMT™ with Merck’s (NYSE: MRK) KEYTRUDA® [(pembrolizumab) ], as listed in ClinicalTrials.gov as NCT03328026, in advanced breast cancer. Initiated in October, the study […]

Briacell Interview

Chimera Research Group: What sets Briacell apart from other immuno-oncology approaches? Dr. William V. Williams, President and CEO of Briacell: Briacell is developing a novel cancer immunotherapy based on a cancer cell line called SV-BR-1-GM a.k.a. Bria-IMT™. It was originally taken from a breast cancer patient, and further genetically altered to express GM-CSF, a stimulator […]

SRPT – Again, WMS-2018 Dystrophin Data Beating the Market Expectation

Yesterday 10/04, at 7:00 am ET, Sarepta Therapeutics (SRPT) with Dr. Mendell released the biopsy data from the fourth patient including full 4 patients “Functional Data” from Argentina at #WMS2018 the 23rd International Annual World Muscle Society meeting Link to the full slide deck: https://www.sec.gov/Archives/edgar/data/873303/000119312518292068/d616670dex992.htm The after-hours share price reaction was wild swing, spiking up […]

Dave Trading – September 2018

*** David Sobek is a disciplined value investor.  Using models, research, and fundamental data, David devises a value for biotech stocks, buys when significantly undervalued, and sells when significantly overvalued.*** As a reminder, this is my personal guide.  You can alter it in accordance with your risk tolerance. >3 Standard deviations – No position 2-3 […]

XENE – Quick note, Positive TMS Data Presented at The European Congress on Epileptology

Today morning, Xenon Pharmaceutical (XENE) reported positive data from its XEN1101 Phase 1b transcranial magnetic stimulation (TMS) study. (LINK) XEN1101 Demonstrates Statistically Significant Reduction in Corticospinal and Cortical Excitability as Measured by TMS-EMG and TMS-EEG XEN1101 Demonstrates Greater Effect on TMS-EMG Resting Motor Threshold at Significantly Lower Dose When Compared to Historical Ezogabine Data XEN1101 […]

Dave Trading – August 2018

*** David Sobek is a disciplined value investor.  Using models, research, and fundamental data, David devises a value for biotech stocks, buys when significantly undervalued, and sells when significantly overvalued.*** As a reminder, this is my personal guide.  You can alter it in accordance with your risk tolerance. >3 Standard deviations – No position 2-3 […]

Bellus – David vs. Goliath Can BLU Deliver A Better Chronic Cough Drug Than Merck?

BELLUS Health (BLU.TO) (BLUSF) is a biopharmaceutical development company based in Quebec, Canada, its pipeline includes several partnered clinical-stage drug development programs, but the company’s lead drug candidate is BLU-5937 which is a highly selective P2X3 antagonist for chronic cough and has the potential to be a best-in-class therapeutic for chronic cough patients who do […]

XENE – Epilepsy and Advocacy Under the New FDA

Xenon Pharmaceuticals (XENE) is a clinical stage biopharmaceutical company focusing on discovering and developing innovative therapeutics for neurological disorders. XENE has an extensive knowledge of human genetics and diseases caused by mutations in ion channels, known as channelopathies, focusing their efforts on novel product pipeline of CNS-central nervous system therapies, to address areas of high […]

August 1 Biotech Update

The sector recovered a little yesterday from last week’s sell-off but ideally we would need to see the sector break into new highs. It seems highly likely that the sector tests the recent highs and the price action at that point is likely to be a strong signal of underlying strength. Given the fundamentals and […]

FDA GT Draft Guidance is Bullish for Sarepta's DMD Pivotal Trial

Yesterday July 11, 2018 the FDA FDA issues 6 new draft guidance documents for gene therapy, clinical development and manufacturing guidance. Human Gene Therapy for Rare Diseases – FDA Draft Guidance for Industry https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM610802.pdf   The FDA guidance noting the pre-existing antibody to GT, this is the strongest SRPT’s & Dr. Mendell point, choosing the AAVrh74 which […]