Replies to post #49466 on NorthWest Biotherapeutics Inc (NWBO)

[GoodGuyBill]

Ready, why did you hold from $12 down to $3 since you apparently knew Linda was a crook the whole time. They-- who may have believed aa was immanent-- have an excuse. What's yours?

[Doktornolittle]

I was thinking about that today, before you posted. How to characterize Flipper's posts? In my view, he always posts an intelligent positive view; The most positive view that still fits within the limits of intelligents. And often the most intelligent view. He does a lot of DD and a lot of thinking.

In my view there is a need for such a view to always be expressed. At the same time, I think that it dangerous to rely only on such a view; but Flipper recognizes that, and so includes a disclaimer stating that at the bottom of his posts.

I have never seen an investment recommendation in Flipper's posts. At least I can't think of one. Not that such would be a crime. Just not his style.

If AA is on the table, Northwest might not mention it if they don't have to. The odds are that the implied efficacy review would end with a continue, and disappoint, and they can't afford that. Further, there is always some chance of it ending worse than a continue, something else they would probably not want to talk about.

I recently made an argument for why an efficacy review is very likely in progress. The board was pretty empty, but some thought the arguments made a lot of sense. The argument was basically that the numbers of screened and randomized patients matches the number that would be needed for a confirmatory trial after AA based on 4+ months PFS projected, and 6+ months PFS projected, respectively. Those being the new and old primary endpoints respectively.

In retrospect, I should not have focused on AA for that argument. The patient numbers needed to perform a confirmatory are the same numbers that would be needed to just continue the trial without AA. However, any efficacy review has some possibility of AA / early marketing approval with confirmatory, as well as some chance of halt for futility.

[flipper44]

She did not "kill" AA. She will not be informed regarding efficacy results until the trial is "complete."

You seem to misunderstand accelerated approval. It means you get conditional approval on a surrogate endpoint until a confirmatory trial is run, it does not, as your posts seem to suggest, always mean approval earlier on in the trial on the primary endpoint -- although it can additionally mean that.

If you think an interim analysis cannot invoke an action by the FDA and/or recommendation by the DMC to terminate the trial early for efficacy which might be countered judiciously by a cautious CRO in Europe and/or the United States, you do not understand the flexibility and understanding oversight committees and/or regulatory agencies are willing to prescribe for immunotherapy trials, and particularly vaccine immunotherapy trials (with particularly long tails) which the FDA drafted supplemental guidelines for in 2011.

Again, LP is blinded until the trial is complete, and she intends to keep you blinded until the trial is complete. Under these circumstances, goings on may still be afoot. Trials can still end early.

I still believe we may have hit the first interim mid June to early July, the screening suspension started around August 1st, and if that is the case, as long as the CROs filed something nearly on time (Sept/Oct), we are on pace for a possible AA at the end of February give or take a month or so. IMHO.

You can believe anything you like.