Replies to post #234847 on NorthWest Biotherapeutics Inc (NWBO)

[marzan]

The event (data) in between Soft and Hard locks can still be included into the Hard Lock as and when it happens as the queries related to them can still be conducted in parallel process, imo


Hope those words in bold is something I want to add to my previous message just to make my thought process clearer to you.

[flipper44]

Regardless, LPLV was completed in the Amarin trial in late June 2018, and apparently the company had results two months later in August, and the public had it in late September.

All this soft lock discussion regarding NWBO is to sow confusion. It is irrelevant. The fact is, the time bottleneck is the SAP buy-in. The trial will otherwise be ready for hard data lock and topline before September 2019.

IMHO.

[meirluc]

No marzan, looking back at the conversation I now feel that soft lock is still not in place but will be sometime in the future. So we already have now almost 47 months of data past the last surgery and a future soft data lock will not constitute a loss of much data.

I now recall that DI also said something about "when the SAP is submitted etc." making me think that it has not as yet been submitted.

I also got the impression that the soft lock period will not be long (perhaps a few months) and will be immediately followed by the hard lock.

[GoodGuyBill]

Too many longs on this board are concerned about not getting answers to these questions. The real concern is most of us don't even know enough about NWBO's pathway to approval to ask the right questions.

Do we know when a soft lock is supposed to occur (apparently not)? did it?

Do we know when the endpoint thresholds (PFS and OS) was supposed to occur (again, apparently not)? Did it?

We keep thinking we know these things. apparently we don't.

Why can't NWBO simply spell out the process with all of the steps once and for all? We should not have to ask DI, Les or anyone else for this info. We shouldn't have decipher FDA regs or read tea leaves and chicken bones. the info should be available.

Another real concern is why are they running the trial this way? are they hiding something? Failure? Outrageously positive trial results until the perfect moment? Who knows..but it seems like NWBO has a life-giving light and instead of giving it to all, they hide it under a bowl. Now, why would they do that?