froggmister,
Yep, seems a whole lot more like they were all waiting on something. A year ago last June it was announced that a newer design of a GMP Flaskworks unit would not be appropriate for fitting out the clean rooms to be built. I was not happy then but knew excessive frustration being expressed at that point would not be helpful. I expressed some disappointment and moved on.
I still believe that approval has always been tied to manufacturing, Flaskworks or similar, ever since delays seemed to start being a cover for taking care of Mr. Woodford’s comment about the “bump in the road”. His additional comments pointed to the bump being related to something expected to be part of product development. Then in 2018 Linda basically publicly begged for help with manufacturing. Now what could that bump in the road possibly be? Maybe manufacturing readiness for what MHRA, NHS, NICE, NWBO, new trials, potential partners, and others see coming is pretty important. Best wishes.
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