NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

I would acknowledge that the lack of a similar full disclosure for NWBO's hold is evidence against my theory (evidence, not proof).

Agreed, there's a reason they haven't disclosed publicly the reasons for the screening halt, and it likely stems from the fact that they are under no obligation to do so until they choose the right time to do so. And given LG and LP are both competent lawyers, and are being advised continually by a slew of other lawyers (given the number of lawsuits they've had to contend with for the past two years), AND having been under the watchful eye of an SEC investigation... it's unlikely that they are hiding anything "untoward" **at least untoward on their part** from the shareholders.

Regarding a supposed interim analysis to have been done in the Summer of 2015.

Two things.

One:
It's reputed that Les has denied this claim to several investors.

Two (an more importantly):
The DMC could see the data for both arms separated out. I believe a reason for a recommendation to stop the trial could be based on seeing "an excess of primary endpoint events in the treatment group". This would not require an Interim Analysis as the DMC would have seen this data at all of it's regular meetings.

So if that is the reason behind such a recommendation, it might take some time to prove to the FDA that those primary endpoints events were really not events. I mean, you'd have to see if the supposed progression went away, correct? And then if and when it did, it would become evident that it was indeed a false progression, because had it not been, well... either the patient would have died, or their GBM tumor went away and they were cured.

So instead of doing a clinical halt, perhaps a screening halt was instead implemented. I mean, safety had been established that point in time to not be an issue by then. But perhaps, as ex has indicated, if proving the primary endpoint was now in contention, one could argue at least halting enrollment to any future patients until that issue was resolved.

Perhaps by the time the screening halt was lifted (Feb 2017), this point had been more than apparent to the FDA. Maybe that was even the reason for all the reviews of the MRI scans. That seems the more likely scenario, given the fact that the screening halt was actually removed.

Besides,
the patients in this trial are living much longer than they ordinarily would,
studies have come out - even from our very UCLA doctors involved in the trial - indicating that psPD in the brain is occurring with immune therapies and they've figured out a way to measure for this now,
Linda Liau indicated psPD due to DCVax-L was practically rampant in her now removed Seattle Science video,
and blog patients in the trial or who are using DCVax-l outside of the trial have been told that pseudo-progression is quite commonly found to occur with this treatment.

So... now what?

Well, if the FDA saw that these patients who were diagnosed with this dreadful disease were actually seeing an impressive increase in their overall survival results (that's the gold standard in these trials you know), then do you really think the FDA are not going to help NWBO figure out a way to grant approval as quickly as possible so that this treatment can be made available to the rest of the GBM market?

And I think granting AA on the blinded data found in the cross over arm would do just that. You get the treatment to patients round the world (well, in four countries), and you let the trial continue as a confirmation for the AA so that all those patients still living can demonstrate just how long they are going to live for. Either way, when the trial would eventually unblind, it would either show a distinct separation between the two arms (treatment and control) and thus be stat sig (that's what you want), or both arms would have lived so dang long that it's obvious beyond any shadow of a doubt that you, Avii, could throw at it that it was due to DCVax-L. And all during that happy time after AA would be granted, DCVax-L would be made available to grateful GBM patients, and shareholders would finally be both proven correct in their assessment and belief in the treatment, and by the corresponding increase in their bank accounts too. See what a wonderful world awaits us?