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Northwest Biotherapeutics (NWBO, $0.86, Buy) Addressing Key Questions Relating to the Possible Approval and Commercialization of DCVax-L in Glioblastoma Multiforme
Introduction The catalyst for writing this update was the MHRA certification of Northwest Biotherapeutics’ Sawston, UK plant for GMP production of DCVax-L for compassionate use. This was a critical step on the path to approval and commercialization of DCVax-L. Having taken pen in hand, I decided to update my reporting on other issues relating to […]
Northwest Biotherapeutics Issues Encouraging Update on Manufacturing Capabilities (NWBO, $1.59, Buy)
Introduction This report addresses three issues: The capability of the Sawston UK plant to manufacture Northwest Biotherapeutics’ dendritic cell vaccine in accordance with regulatory requirements and to scale up to manufacture it in substantial quantities. (Note that in the US, this product is referred to as DCVax-L, but may go by a different brand name(s) […]
Northwest Biotherapeutics and the Robinhood Trading Phenomenon (NWBO), Buy, $1.59)
Stunning Stock Price Movements for GameStop and AMC Entertainment There has been a lot of news coverage this week about the trading of two stocks which have for some time been the subjects of intense short selling: the videogame retailer GameStop Corp.(GME)and the theater chain AMC Entertainment (AMC). On January 21, GME closed at $43.03 […]
Northwest Biotherapeutics: Waiting for Top Line Data on DCVax-L (NWBO, $1.25 Buy)
There has been frenetic trading in Northwest Biotherapeutics stock as investors await the release of topline data from the DCVax-L phase 3 trial followed by the release of the full data set. There was speculation that the data could be presented at the Society for Immunotherapy of Cancer (SITC) in a poster session on either […]
Northwest Biotherapeutics: Reason for Yesterday’s Stock Surge (NWBO, Buy, $1.12)
Overview Northwest Biotherapeutics stock was on fire yesterday as the price increased 35% to $1.12. The strength appears to be attributable to two posts on the investor website iHub. Thoughts on First Post The first post was as follows: “In the EU Clinical Trial register, it shows that the primary endpoint for the DCVax-L trial […]
Northwest Biotherapeutics: Two Recent Press Releases Indicate that Manufacturing is on Track to Support Commercialization of DCVax-L (NWBO, Buy, $0.55)
Clinical Data Offers Much Hope that Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma Multiforme Will Be Successful Northwest continues to guide that the long anticipated release of topline data from the phase 3 trial of DCVax-L in newly diagnosed glioblastoma (ndGBM) will be after Labor Day and likely in September. This trial is […]
Northwest Biotherapeutics: (NWBO, Buy, $0.35) Management Issues Guidance That DCVax-L Phase 3 Trial Results Will Be Released Sometime After Labor Day
Investment Overview: Highly Asymmetric Outlook Northwest Biotherapeutics has guided that it will report results of the phase 3 trial of DCVax-L in newly diagnosed glioblastoma (GBM) sometime after Labor Day. This results in a highly asymmetric outlook for the stock price. In this report, I present a plausible hypothesis that over the next year the […]
Northwest Biotherapeutics: We Are Just Several Weeks from Release of Topline Data in Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma Multiforme (NWBO, $0.36, Buy)
Investment Overview In the 1Q, 2020; 10-Q regulatory release on June 24, there was a section that went into some detail on the pending release of topline data from the phase 3 trial of DCVax-L in newly diagnosed glioblastoma. It describes how Covid created major problems in compiling data from the phase 3 trial that […]
Northwest Biotherapeutics (NWBO, Buy, $0.26) Detailed Results for the Phase 3, DCVax-L Trial in ndGBM Are Imminent
Introduction Results for the phase 3 trial of DCVax-L in the treatment of newly diagnosed glioblastoma multiforme (ndGBM) should be released in late June or early July. In anticipation, I wanted to reiterate why I believe there is a reasonable possibility for a successful outcome. If so, this would constitute a major advance in the […]
Northwest Biotherapeutics: Why I Believe there is a High Probability for Approval of DCVax-L (NWBO, Buy, $0.21)
Investment Overview There are Good Reasons to Believe that Phase 3 Trial of DCVax-L in Newly Diagnosed Glioblastoma Multiforme Will Be Successful and Lead to Approval The phase 3 trial of DCVax-L is nearing unblinding as discussed in my November 21, 2019 report. and investors are awaiting anxiously to see if the trial will be […]