It is true that NWBO shouldn't be able, and shouldn't attempt, to assert influence over the DMC, but it may well be the case that what to do based on interim results is left to NWBO. More often than not a DMC makes a recommendation to the sponsor on what to do (stop or continue), but the call belongs to the sponsor.
I have never seen a situation where a DMC recommends a continue based on safety and leaves results "pending" on efficacy. What is most likely the case is that either (1) NWBO has the efficacy results and doesn't like them, or (2) they specifically instructed the DMC not to opine on efficacy (yet).
I'm beginning to suspect the latter, but there's no way to know. All we know is that the recent pattern of behavior here from the company is bizarre, and AF is simply point that out.
I'm not a big AF fan, have been on the wrong end of his stuff, but literally everything he's said about NWBO is true -- raw facts. This stock is in the middle of a huge short squeeze right now, which is doable when the CEO controls more than half the shares directly or through controlled entities (Toucan and Cognate).
Strangest setup I've ever seen. But not even a stranglehold on the float is going to save this thing when the results of the trial are out. They should be able to raise a bunch of cash in a secondary now, assuming that technically they have not received the efficacy results from the interim. So they'll "keep going", although you baggies in at these prices won't care about that.
Yeah. That stupid Adam Feuerstein. When he explains that the German thing says nothing about drug efficacy, is likely to result in de minimis revenues if any, and is going to be completely overshadowed by the Phase III futility stop, I'm going to be SO angry. Who asked him anyhow?
I'm the first to admit I did not see a short squeeze of this magnitude coming, but if you like money, it's time to take your chips to the window.
Anyone who doubts this should spend a little time reviewing the recent history of GALE. It's a primer for what is about to happen here.
There's a call with the company on last year's results tomorrow that's supposed to include a pipeline update, so folks are getting their money down just in case. That's what I figure...
The time for misdirection is soon coming to an end.
The drumbeat of those efficacy data is getting LOUDER and LOUDER, and all the screwy, distracting press releases in the world aren't going to change things.
The efficacy data are "pending". And by "pending", they mean "we have them and don't want to release them (yet)". And the reason for that? Take a wild guess.
aawilliam: How long do you think they'll be able to keep this "pending" ruse up?
I'm wondering if the DMC members will have an ethical issue with how they've mangled this interim....
aawilliam -- you have hit the nail on the head. This is simply, well, not done in a well-controlled trial.
It's a device for a financial goal. When the results finally arrive, there will be pain and lots of tortured explanations...
The question is where the futility p-value is at 60% of the events. Since I believe this drug is inert, if the futility boundary is p 1, then it's a coin toss. But I think it's around 1 at 50% of events. If it's at p 0.5, the chances of a stop for futility are much higher.
The delay is NOT bullish -- that much is clear.
My guess is "never", because I believe they're going to stop the trial for futility, and the event counting will end.
I'm not a Twitwit, unfortunately, so anyone who is should please feel free to pursue clarification with AF on Twitter....