ex please reread...
we expect the costs related to the Phase III trial to continue declining further as the trial moves toward completion,
From 10Q 8/9/16
I truly believe we get an update on our PIII trial in the near term.
Read these paragraphs closely. "toward completion"
Note last sentence knowing the FDA WILL NOT approve a biologic or any drug for that matter if adequate manufacturing capacity in not in place....
During the quarter ended June 30, 2016, our research and development expenses were greatly reduced compared with the quarter ended June 30, 2015, as we are now past the peak cost periods in the Phase III trial of DCVax-L for GBM brain cancer, we expect the costs related to the Phase III trial to continue declining further as the trial moves toward completion, and we have completed the Phase I trial of DCVax-Direct.
We are currently pursuing preparations for multiple Phase II trials. We expect that our research and development operating costs will remain at a substantially reduced level until the Phase II clinical trials are ready to proceed with enrollment and execution. We have implemented lower levels of fundraising while our research and development costs have been substantially lower. We plan to increase our fundraising activities as the upcoming Phase II trials become ready for enrollment and execution.
Our operating costs include ongoing development work relating to our DCVax products and their manufacturing, such as the development, testing and optimization of different product preparations and methods, the design, engineering, sourcing, production, testing, modification and validation of manufacturing automation systems, disposable sets to be used with the manufacturing automation systems, and manufacturing processes, product ingredients, product release assays, and other matters, as well as development of standard operating procedures (SOPs), batch production records, and other necessary materials.
Our operating costs also include the costs of continuing our ongoing Phase III trial in the US, UK, Germany and Canada (with DCVax-L for brain cancer), early access programs in Europe, and preparations for multiple Phase II trials. The preparation costs include product and process development, upfront payments to the clinical trial sites and the CROs managing the trials and other service providers, and legal, regulatory and expert expenses related to regulatory approvals, institutional approvals and clinical trial agreements with each site, database development, training of medical and other site personnel, trial supplies and other. Additional substantial costs relate to the expansion of manufacturing facilities and capacity, in both the US and Europe.
