Full of BS. From a regulatory approvals perspective, it’s always quality control that matters! Not volume, but continue to BS. Manual production (Sawston facility) was certified for commercial production recently so there is no hold up on that, but again continue to deflect & lie, just like many of LP’s minions here. LP herself confirmed at the last ASM that they don’t need Flaskworks for regulatory approvals in any jurisdiction. Manual production approval will suffice and rightly so.
Dozens of complex cell and gene therapy products approved by FDA and other regulatory bodies in the last decade. NWBO is not the first. None of them were rejected because of volume considerations. KITE is a prime example.
Flaskworks commercial production approval is so far out. It’s not even funny. No excuses when Flaskworks is not approved for commercial manufacturing in 2025 and 2026, OK?
I expect LP to come up with more excuses in another 6-9 months around Flaskworks. Maybe she will come up with supply chain or budgetary constraint issues next, LOL! Given NWBO’s pace, I’d be surprised if they actually get it approved for commercial production in 2027 as well.
What all of this posturing from minions suggests is that UK approval is far out.
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