Clinical Supply Coverage
Will released supply stay ahead of enrollment over the trial, and where does coverage first break?
Holds to Month 8, breaks Month 9
Coverage holds through Month 8 as banked inventory absorbs the ramp.
Month 9: enrollment passes QC-release throughput and the buffer is gone.
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
Enrollment rises each month. Released kits can carry forward, but only while the inventory buffer stays ahead of demand.
Model logic
Tracks monthly supply, release, inventory, and enrollment across the 10-month trial.
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.
In this model, coverage through Month 10 requires QC release of about 361 kits/month.
Raise QC-release capacity from 340 to about 361 kits/month to maintain coverage through Month 10.