Second CTEP Review

1. Phase 1/Phase 2 Timeline: Unsolicited LOIs – Non-CTEP IND or No IND Phase 1 and Phase 2 <100 Patients Day 1 – 60: LOI Approval NCI Receipt of Unsolicitaed LOI Consensus Evaluation Resubmission of LOI and Final Consensus Evaluation If LOI is “Pending” Conference Call scheduled WEEK 1 (Day 1) WEEK 5 (Day 30) WEEK 7 (Day 44) WEEK 9 (Day 60) 30 days 14 days 16 days Transition Period: If Pediatric, Brain/CNS, or Melanoma Phase 2 Concept ≥ 100 Patients will follow this outline until Steering Committee established If LOI is Approved at Day 30 Day 60 – 120: Protocol Development PI Writes and Submits Protocol (use of CTEP protocol template and Library of Materials if CTEP IND agent even though not under CTEP IND) LOI Approval NCI Protocol Receipt WEEK 18 (Day 120) WEEK 9 - 18 (Day 60 – 120) WEEK 9 (Day 60) 60 days “Timeout” for industry approval and/or drug commitment Day 120 – 210: Protocol Approval Protocol Approval on Hold, IRB Submission,FDA Submission, Preparation for Protocol Activation, Final CTEP Approval, and Status Update Indicating Activation Conference Call to Review Major Issues Resubmission of Protocol Second CTEP Review CTEP Review with Comments WEEK 24 (Day 164) WEEK 22 (Day 150) WEEK 30 (Day 210) WEEK 26 (Day 178) WEEK 27 (Day 185) 14 days 14 days 7 days 25 days “Timeout” for IRB & FDA review * * * Deadline for Protocol Activation is 540 days including “timeouts” * * * Version 1.0 13 April 2010