this is a long and complex process, especially when combined with the creation of a cgmp manufacturing facility that needs to satisfy the fda requirements.
25-Apr-16: "PMCB's Live Cell Facility Commissioned for GMP Manufacture"
Are we giving Kenny a PASS again. That's 3 yrs ago, the "creation" already occurred.
It’s never been done before so there will be things to learn along the way
Aah, so now we are "along the way". Instead of waiting with baited breath on the mythical IND, now we are waiting for Kenny to learn some more things "along the way". PASS.
The complexity and accuracy are complicated time dependent requirements
When compared to the emerging immunotherapies, there's nothing complex about creating the CIABs. Lohr did it in 1999. Via marketing agreement, Sigma sells kits to do it. With ZN claiming for years, they could encapsulate anything the customer wants.
A year is not a long time in biotech for big pharma
PMCB has been going at it complete with Kenny PR pumps since 2012. Just slightly longer than "A year".
and this is a very small operation attempting a new chapter in medicine and it’s delivery
There's no new chapter in delivery being represented by the Kenny Wonder Treatment. Unless it's a primitive one. Try instead an antibody that attaches to a cancer cell via a highly expressed cancer cell antigen, and delivers a drug payload into the cell. There's a Phase 2 CT in progress with top line results due in Aug.
All these years since 2012 Kenny has been piddling around, and still is... the biotech world has left behind the antiquated CIAB concept from 1999.