Below is my summary of 8K just issued and why I find this a very positive 8K prior to interim results on DCVax-L and DCVax-Direct being released.
Why would NWBO issue an 8K on immediate expansion of manufacturing in US, UK and Germany for both products before interim on L and Direct if these trials are not having regression or complete remission of the tumors? eventual commercialization as well?
Why announce this now and not wait until DMC decision on interim is public knowledge? Could this be a subtle indication we have some big news coming? No one knows for sure but my gut tells me we could get DMC update pre-market Monday before Dr. Bosch presentation later in the day.
The DMC may just have trial continue to the 2nd interim analysis but I have to side with our board member Flipper's extensive due diligence and his research on why the DMC may halt the trial due to statistically exceeding the Primary Outcome Measure for progression free survival and Secondary Outcome Measure for overall survival in the DCVax-L trial. NWBO has a very good working relationship with the FDA and are both in Bethesda, Maryland here is the US. Have a great weekend everyone! GLTA!
Together, these Agreements provide for substantial expansion of manufacturing capacity for the Company’s programs, in multiple regions, as well as development of the necessary systems and logistics, and other near-term and long-term preparations, for large scale scale-up of the Company’s programs.
The DCVax®-L Manufacturing and Services Agreement replaces the prior manufacturing services agreement, dated April 1, 2011 (the “Prior Services Agreement”), between the Company and Cognate, and provides for manufacturing of DCVax®-L products for various cancers, including brain cancer, and related services. Throughout 2013, the Company requested that Cognate provide, and Cognate did provide, manufacturing services for substantially larger numbers of product lots of DCVax®-L (and substantially larger numbers of tumor tissue collections and leukapheresis collections) than the Company had contracted for under the Prior Services Agreement, including by extending production operations through the nights and weekends at the Company’s request, although the Company had not contracted for such extended production.
The DCVax®-L Manufacturing and Services Agreement provides for substantial expansion of the manufacturing capacity and services dedicated to the Company’s DCVax®-L products along with expansion of the Company’s DCVax®-L program. This includes a substantial increase in the dedicated facilities and the number of production lots per month.
The DCVax®-Direct Manufacturing and Services Agreement provides for these services to continue and to expand substantially along with expansion of the Company’s DCVax®-Direct program. In return for the services provided by Cognate during 2013, and the completion of milestones by Cognate, and to cover the initiation of substantially expanded DCVax®-Direct manufacturing services following execution of the DCVax®-Direct Manufacturing and Services Agreement, the Company will make a Milestone and Initiation Payment. Such payment is comprised of 1,683,451 shares of common stock of the Company and a warrant to purchase 803,224 shares of common stock of the Company. The warrants are exercisable at $4.00 per share, and have an exercise period of five years from issuance.
The DCVax®-Direct Manufacturing and Services Agreement provides for substantial expansion of the manufacturing capacity and services dedicated to the Company’s DCVax®-Direct products, above the levels in 2013 prior to this Agreement. This includes a substantial increase in the dedicated facilities and the number of production lots per month.
The Ancillary Services Agreement provides for other categories of services that will be needed on an expanded scale for clinical programs, compassionate use and other early access or expanded access programs, and eventual commercialization. The Agreement will include cryopreservation and storage services, clinical and commercial support services; supplier sourcing, validation and monitoring; shipping, distribution and logistics; scheduling system and other software design and development; recordkeeping; product and process validations services; a quality agreement for quality control and quality assurance; and such other services as may be necessary.
The Company has requested that Cognate accelerate and expand these services pursuant to the Ancillary Services Agreement, in order for such services to potentially be able to be used for compassionate use and/or other early access or expanded access programs, in addition to clinical programs and eventual commercialization
Cognate provided such services throughout 2013, including in regard to negotiation and development of expansion of existing manufacturing in Germany, development of plans for further large-scale expansion of European manufacturing, evaluation of the operational, financial and regulatory aspects in three European countries for new manufacturing capacity and in Israel for expanded and upgraded manufacturing capacity, and an intensive planning and development process in the U.K.
The term of each Agreement runs until the later of seven years from its Effective Date or five years after the first commercial sales of the respective DCVax® products being developed under the respective agreement pursuant to a biologics license application or marketing authorization (not a compassionate use, hospital exemption or other early access or expanded access authorization), unless terminated earlier.
