Replies to post #823403 on NorthWest Biotherapeutics Inc (NWBO)

[10baggerz]

Agreed, and that is exactly why I shared it.If you go back and read my initial three questions, I did NOT use the term conditional approval.Instead, I asked whether any manufacturing preparations were underway in anticipation of full approval.In other words, it may be as simple as him not knowing the precise status and responding to my question as best he could.At the same time, there could also be something more to it.As Baxers astutely pointed out, one of the primary reasons some MAAs can take well over two years to reach a decision is when regulators are considering a form of conditional approval or requiring additional commitments before granting full authorization.Of course, conditional approval can cover a wide range of scenarios.At one end, it could involve significant requirements such as confirmatory Phase 3 or post-marketing trials to further establish efficacy or safety.At the other end, it could be more limited conditions, such as enhanced pharmacovigilance, patient registry participation, manufacturing validation updates, labeling refinements, or additional patient monitoring protocols.My only point is that his response should not automatically be interpreted one way or the other.It may simply reflect incomplete knowledge, but it could also hint that there are ongoing regulatory or manufacturing steps still being worked through behind the scenes.

[flipper44]

It’s a question of stage. It could sound endless, but the MHRA process is an external time keeper, so it’s not endless.

Even entering the MHRA process demonstrated some belief by NWBO (and I believe their less formal discussions with nice/mhra) that they were mature enough to engage in the maa process — albeit, w/my rearview vision, I think they knew they’d need more maturation within the maa process than most, and their definition of clock on and clock off would resemble a warped clock in a surrealist painting.

So what did George Z mean that full versus conditional approval was left to be determined? It comes down to stage, and the stage is 153 calendar days post likely successful second CHM.
The science is good, the new regs are activated, the manufacturing is a go, the initial external leukapheresis clinics are already contracted and trained with a larger NWBO leuk clinic being prepared inside a hospital for further expansion. IMO.

Well, what are we waiting for?

[StonkMaster]

Sorry, but his name is George. Assuming we're talking about George Zavoico.