The UK is/was the perfect sized initial testing ground, regulatory environment and commercial launchpad for artisan DCVax-l (assuming approval). Once automation in a closed system is accomplished through Eden’s certification, the world will be DCVax’s testing ground, regulatory environment and commercial launch pad.
agreed. Still, an FDA approval is the golden standard for biotechs and I remain of faith that unfortunately due to the FDA's stubborn incredibly unreasonable demand for individual patient-level data NWBO has not submitted a BLA. Did our newly elected dictator-in-chief not promise to abolish the FDA?
I agree it is a brilliant move to seek approval in the UK while perfecting Flaskworks. Now CLR can establish a single cost model from production at Advent.
Sure let's ignore rhe fact that the fda told these guys to pound sand and nwbo failed to disclose this post phase 3 meeting detail. But yeah going to a small market that is notoriously non-paying is brilliant..cough cough. Confirmation bias anyone? You don't actually believe that BS you wrote do you? You do know they need to make revenue right and they are broke?