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Re: Evaluate post# 300479

Thursday, 08/20/2020 1:35:48 AM

Thursday, August 20, 2020 1:35:48 AM

Post# of 708742
Evaluate, obviously it’s just speculation, but that’s all we’re left with. It probably made sense at some point last year to just wait for the results of this trial since so much is going to be learned about DCVax from this trial. The composition of the survival tail will be of great interest, and analysis of the various subgroups of patients that make up the tail will help to identify patients that best respond to this treatment, and these biomarkers will likely be used in future trials to select patients. In addition, I think surrogate endpoints based on tumor response will be used to demonstrate efficacy, (which should be very rapid) which should also help to speed them up.

And yes, I took note of that language in the 10Q as well, but there was also this:

Our operating costs also include the costs of preparations for the launch of new or expanded clinical trial programs, such as our planned Phase II clinical trials. The preparation costs include payments to regulatory consultants, lawyers, statisticians, sites and others, evaluation of potential investigators, the clinical trial sites and the CROs managing the trials and other service providers, and expenses related to institutional approvals, clinical trial agreements (business contracts with sites), training of medical and other site personnel, trial supplies and other. Additional substantial costs relate to the maintenance and substantial expansion of manufacturing capacity, for both the US and Europe. Our operating costs also include significant legal and accounting costs in operating the Company.
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