Replies to post #34594 on NorthWest Biotherapeutics Inc (NWBO)

[Ready4bluesky]

It is very possible that NWBO will see a similar reaction as NLNK encountered today with a continuation at the 1st interim.

Investors will see it for what it really is (further delay, further dilution, etc.). Thus the recent attempts here to spin it as a "positive" event.

I clearly remember all of the 1st interim projections made by the diehards last year and the claims that it would be foolish to be on the sidelines..blah blah blah. What a bunch of baloney! I'm sure we'll see more of the same in the coming months.

[flipper44]

I thought so. Koman, quit ducking. I still think, IMHO, that they will pass stat. sig. for the primary endpoint at the 1st IA, what I am saying is that if they do, a continuance may still be required if they are using the Accelerated Approval approach I highlighted in the paragraph I reposted last night and today.

In other words, even for people like me, who diversify their funds, and have done their due diligence on this company and believe statistical significance is likely at the first interim despite the higher statistical hurdle, there is a possible separate roadblock that may prevent any opportunity for an early halt, and this might be perceived prematurely by unsophisticated investors as not having spectacular results.

I'm not asking them to put forth their exact stopping boundaries, although they did provide them last time we went through this with the smaller version of this same trial, I am asking for the mere courtesy that they describe what the procedure looks like if they apply for Accelerated Approval upon reaching Stat. Sig. (they have previously indicated they intend to apply for AA). In other words, does the trial continue blinded just as it would if they had not reached statistical significance at the first interim?


And to answer your other question:

Also, if such a halt for efficacy was prespecified in the statistical analysis at the interim and it is met I cannot see why it wouldn't trigger an automatic halt for efficacy RECOMMENDATION at which point LP can still continue the trial to completion for other data maturation as the SP
spikes to 20 or more. -- Koman

You know the answer to that Koman. If she did not convey the halt recommendation, she might violate the SEC disclosure rules, if she tells the public, she basically removes the integrity of the blind. That's the problem with discussing it after the interim analysis starts.