You still talking about this?! Your posts have become very cryptic in the last few days.
Our operating costs also include the costs of preparations for 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, in both the U.S. and Europe.
If this is the case I'm still in disagreement. It was either a typo or if you read the first sentence of the paragraph, they are talking about manufacturing capacity for future PII trials.