I wonder if this is the reason for the continued selling. They can't even figure how how and where to deliver the treatment. From the just issued MD&A:
cGMP Manufacturing with University of California, Davis
As a part of the upcoming clinical trial, BriaVaxTM will be manufactured under current Good Manufacturing
Practice (cGMP), the highest standard of manufacturing prescribed by the FDA. The Company signed a
Definitive Agreement with the University of California, Davis Health System (“UC Davis”) for cGMP
manufacturing of BriaVax™ on June 11, 2015, as a result of positive feedback from the FDA to the
Company's response letter dated May 19, 2015. Under the terms of the Agreement for Services, the UC
Davis Institute for Regenerative Cures will provide a number of services to BriaCell, most notably the
cGMP manufacture, quality control and part of the release testing of BriaVax™ to support the Company’s
upcoming Phase I/IIa clinical trial. In the latter context, recent activities at the UC Davis GMP facility
included experiments to optimize the irradiation conditions to improve the safety of BriaVax™. Such
irradiation studies support the anticipated role of the GMP facility as “formulation laboratory” for the
clinical trial. In short, BriaCell plans on initiating its clinical trial at a clinical site less than 4 hours of drivetime
away from the GMP facility in Sacramento, CA where BriaVax™ would be formulated the day of
patient inoculation. Formulation would entail thawing a therapeutic dose of BriaVax™, irradiation to
prevent replication (“growth” in the patient) of BriaVax™ once injected into the patient, and resuspension
of BriaVax™ in an infusible medium.
Move of Research laboratory from Pasadena, CA to Berkeley, CA
Following the appointment of Dr. Markus Lacher as Head of R&D, BriaCell relocated its Research
laboratory in September 2015 from the Pasadena Bioscience Collaborative (PBC) incubator network in
Pasadena, CA to 820 Heinz Avenue in Berkeley, CA. The new location is in the biotech-friendly San
Francisco Bay Area and offers access to countless resources offered by the California Institute for
Quantitative Biosciences (QB3).
Clinical Operations – Search for Clinical Sites
In preparation of the Company’s planned Phase I/IIa clinical trial, substantial efforts have been made to establish relationships with potential clinical sites and site principal investigators (PIs). Initial attempts were made at hospitals in the Los Angeles, CA area. Recent efforts were dedicated to site selection in an extended San Francisco Bay Area, CA region. Practical considerations included vicinity to the UC Davis GMP facility in Sacramento, i.e., the BriaVax™ manufacturing location, permitting formulation of the BriaVax™ vaccine at the GMP facility the day of patient inoculation and courier-delivery to the treatment site. |
