Replies to post #117636 on NorthWest Biotherapeutics Inc (NWBO)

[Milner1]

that is true; but the fda requires it; does NOT mean fda approval is any more or less likely.

[HappyLibrarian]

If HE and EAMS are any guide the validation is mostly talk, and little action.

I suspect any head start is mostly illusory and the excuse will be lack of money.

[EODCoCo]

You're absolutely right Flip. The puzzle pieces are there and it only makes sense considering that if L is approved, other lines could quickly follow. It's the technique that's the most important, the vaccines are made to the subject. If the process is correct, so then, will be the vaccines. It's the beauty of patenting DC technologies, IMO.

[antihama]

It would be difficult to know then, in May 2017, where the company exactly is when it states, "going forward, we will have to undertake process validation work," because they have already conducted validation work throughout the trial processes.

Exactly right! From the get go they will have a validated process raring to go upon approval but it won’t be enough for all the potential patients hence they'll need to expand the manufacturing capacity that DCVax-L will treat e.g. get those clean rooms up to snuff. Or perhaps it’s to get a closed system validated? Or to get Sawston going? As you say it’s difficult to know but IMHO all very positive.