SSPLAXClinical Supply Coverage
Will released supply cover the plan, and what happens if enrollment runs hot?
Coverage holds through Month 10
Baseline: coverage holds through Month 10.
Enrollment runs hot: coverage breaks in Month 9.
Trial horizon
Released inventory carries forward until demand overtakes the buffer.
Before the break
Early surplus is banked as released inventory.
At the break
Enrollment passes release throughput after the buffer is exhausted.
Situation
The current enrollment plan is workable. The decision is whether it remains workable if enrollment runs ahead of plan.
Model logic
Tracks monthly supply, release, inventory, and enrollment across the 10-month trial.
The baseline covers all 10 months and closes with the inventory buffer fully used.
Under Enrollment runs hot, inventory covers the early ramp, then runs out in Month 9.
More drug substance does not help while QC release stays at 340 kits/month.
Raise QC-release capacity from 340 to about 361 kits/month to maintain coverage through Month 10.