Monday, January 03, 2022 1:10:14 PM
People tend to forget that NWBO and contractors have had 14 months in which to develop a BLA if they chose to do so. The blur/flaw in peoples’ brains is the faulty thinking that a publication and BLA can’t be worked on concurrently.
Ex knows it can, and he knows if the data is good, they’ve had plenty of time since October 5, 2020 to run a BLA through the process.
He also knows, until now, NWBO’s capacity to meet an increasing manufacturing demand has been impossible.
It’s really that simple. Good results are needed and the ability to increase/ramp manufacturing. They either had good results or not by October 5, 2020, but they have not had GMP certification at Sawston until now.
So, if the results are good, then manufacturing is the only bottleneck.
That’s why we are waiting, IMO.
Recent NWBO News
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