definiens: or means, with respect to each Program, the desired attributes for an aspirational drug product to treat, delay or prevent such Program 's Indication . These attributes will be determined through an understanding of current and future unmet medical and market needs, and of the product performance necessary for Regulatory Approval and competitive differentiation at the time of anticipated launch . A TPP should contain information on at least the following parameters : [ ndication(s ) ; Summary product proposition ( e.g., improved symptom reliever, disease modifier ) ; Target label summary - outline basis for regulatory approval ; Target patients for drug -segment(s ) of patient population for whom drug would be most relevant ; Clinical efficacy -key endpoints, acceptable clinical effects versus baseline and placebo, main comparators ; Safety and tolerability -acceptable / unacceptable level and types of adverse events, contra - indications, drug interactions ; Presentation / administration -route and frequency of administration ; Cost of Goods -target threshold level for cost of goods for finished commercial product ; Competitive set -current gold standard and treatment options, those expected at time of potential TPP launch ; Timing information -time period of future product launch for which TPP is relevant