NorthWest Biotherapeutics Inc (NWBO)

[ou71764]

I am a newbie both to clinical trials and NWBO. I've read the boards for a few weeks. I had a few questions I was hoping some of the knowledgeable people here could help me out with:

1) Is there a link that anyone has or an old post that would explain the trial basics? I'm not looking for an in depth explanation just the basics of how the trial works.

2) From what I gather NWBO needs Cash fast. Is there any chance at all they will be able to get any Debt financing?

3) Is "Summer" the best estimate of data lock?

4) If FDA approval was to happen, what would an average time frame be from data lock to approval?

Thanks in advance.

I'm not the best one to assist you, but evidently I was the only one.

At the highest level, it was a basic FDA trial - some patients got a placebo and some got the vaccine. No one knew which was which. Then they measured a primary and secondary outcome for all patients in the trial. Primary was progression free survival (PFS) and the secondary was overall survival (OS).

From a recent company PR:

There are 331 patients enrolled in the Trial. The Trial endpoints involve thresholds of 248 “events” for PFS and 233 “events” for OS. PFS events are primarily tumor progression (i.e., recurrence), although they can occasionally be patient deaths which occur without prior evidence of tumor recurrence. OS events are patient deaths.

In my opinion the only relevant press release will be the one that gives the topline data on the primary and secondary outcomes. I don't expect it until later in the year.

Financing before then is up in the air. I don't know what to expect, but I hope we see debt financing.