The major features of the EXPEDITED DEVELOPMENT PROGRAM includes:

1 EARLY CONSULTATION with the FDA both at the pre-IND stage and at the end of Phase 1 should result in agreement on attesting plan than can allow for the approval of a product after the completion of Phase II testing. 2 RISK BENEFIT ANALYSIS 3 Phase IV STUDIES WILL BE EMPLOYED TO LEARN ADDITIONAL INFORMATION ABOUT THE RISKS, BENEFITS AND OPTIMAL USE OF THE DRUG. These will be post marketing studies and might include investigation of different doses or patient populations. 4 FOCUSED FDA REGULATORY RESEARCH (e.g. development of manufacturing standards and assays for vaccine or biotechnology products) 5 ACTIVE MONITORING OF CONDUCT AND EVALUATION OF CLINICAL TRIALS 6 Safeguard for patient safety will all still apply a key to expediting the process is earlier and MORE FREQUENT CONSULTATION with the FDA to each early agreement on the design of studies needed for the approval of new drug.