Looking at this from a different perspective, based on GZ's recent email to Lefty49, it seemed to be abundantly clear that the company never thought that the MHRA would take this long with the application. With this in mind, do you really expect us to now beleive that the company - who in your apparent route to MA would have known long ago that they needed FW validated and a C Suite in operation for marketing approval - then delayed getting the C Suite underway until now - potentially long - after they actually expected to get approval? That doesn't make any sense whatsoever!
IMO the plan was always to submit the MAA without FW and begin with artisinal produciton using the existing Advent facilities and then change the production method over to automation using the forthcoming C Suite and FW upon it's validation after the necesary regulatory steps (a Type II variation) to prove equivalence have been completed.
The story with NICE is likely not so clear cut and I am personally not under the illusion that NICE are definitely going to approve DCVax-L until automated manufacturing is approved. If NICE have already indicated to the company that they wont approve the higher cost of manual manufacture then I do hope that the NICE evidence submisison for automated manufacture can be submited in-advance soon after MA for manual manufacture. I personally dont see why it couldnt be as long as the company have already calculated the cost of automated scale production. Interested to see what other think about this.
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