hyperopia,
I agree with this except that I also believe they had a contingency interim plan for artisan method use initially as a backup if results came in less stellar than expected. I believe that back up plan was jettisoned when the company saw the unblinded data and this led to the time frame we were left with before news waiting for closed system validation. It was at this point, validated by the Cognate/CRL moves, that I began the manufacturing, manufacturing, manufacturing mantra. Best wishes