Sep. 10 at 2:25 PM
$LCTX "Go for Throttle up"
the evidence increasingly looks like Roche/Genentech is building the manufacturing, analytical, surgical and development infrastructure for OpRegen as a potentially commercial-scale asset,
not simply running a 60-patient exploratory trial.
The shipment data is the first thing I would take seriously
So if those 143-unit shipments represent clinical drug-product units, 286 units in two months is a very substantial amount relative to a 60-patient trial.
But I would not interpret 143 = 143 patients.
Cell-therapy manufacturing has:
* QC/release material
* stability inventory
* reserve doses
* manufacturing failures/rejections
* cohort changes
* shipping losses
* backup inventory
* potentially different formulations/process versions
* future clinical supply
They’re turning the manufacturing process into a measurable, standardized, scalable process.
Cont:
