Replies to post #27601 on NorthWest Biotherapeutics Inc (NWBO)

[Evaluate]

I noticed some of your estimates still are unchanged from your SA article, including:

-If placebo median PFS is 12 months (15 from surgery) DCVax group is over 19 months median PFS.

You did classify this as the less likely scenario.

But ... in this case there would only be a 7 month difference between pl & tx?
And yet the trial needs to provide stat sig on a 4 month difference?


Also, your SA article shows:

This 16 months median OS with best surgical procedures and the only effective treatment on the market (temozolomide) may finally, at long last, be improved upon. And not just by a little bit - rather, a total coup, raising median OS to some 36 months, more than doubling what is possible with best SOC alone.

Does this still jive with your current thoughts? That's a 20 month improvement in median OS, which would be great.

[sentiment_stocks]

Pyrr (and anyone else interested) - regarding the 72 psPD arm, and current trial enrollment figures…

I’m not sure this is an accurate assessment:

-I think 50 were enrolled in the randomized psPD arm before May 2014, and that that arm is closed, and 348 will be enrolled in the main cohort by Q1 2016.

Here’s my reasoning on this:

First:
The company has acknowledged the existence of the 72 arm of psPDs in their August 9, 2013 PR where they state:

“The third modification involves dropping an extra arm of the trial which is gathering data on patients who do not meet the eligibility criteria for enrollment in the body of the trial which will form the basis for any product approval decision.”

In the same PR, they also state:

“Accordingly, dropping this side group in Germany as directed by the PEI can readily be done without impacting the trial. The trial will continue to include the extra arm in countries other than Germany.”

As I indicated a few days ago, the protocol specifically states that the rapid progressors will not be enrolled - but that the true psPDs will be randomized and enrolled.

In addition to the 240 patients, approximately 72 patients with newly diagnosed GBM with evidence of possible progressive disease at baseline will return at 10 weeks post radiation therapy for a repeat MRI. Patients who are then determined to have progressive disease will not be enrolled and the remaining patients, (pseudoprogressors), will be randomized 2:1 into a separate arm to assess the safety and potential efficacy of DCVax-L in patients with pseudoprogression.

And the August 11, 2014 PR says nothing about closing that arm. Perhaps you think they closed that arm because they moved them all into the 55 information arm - but that is not what the PR said. The PR simply says the 55 IA is made up mainly of rapid progressors (those rapid progressors that might have made it into the 72 arm if they’d not been determined to be rapid). It was always intended that the rapids would not be enrolled in the trial - and they had to go somewhere. There was a vaccine made for them… hence, the 55 IA arm.

That still leaves us with the 72 psPD arm that has had no PR state it has been removed or eliminated from the trial. I would think if that were their intention, they would have mentioned it in the PR.

And the August 11, 2014 PR also stated:

“The current trial plan involves counting 110 “events” from among the 312 total patients in the trial to evaluate whether the primary endpoint is met. “

Then the PR follows with the company is…

“increasing the 312 number to 348” and the 248 events will be counted from the the 348 total patients”

And since the 72 arm has not been PR’d away, and the company intends to count events from the full trial enrollment, which includes the 72 arm, then it follows that the company FULLY intends to count events from the 72 arm.

And since to count the 72 arm, the trial has to have a p-value of .01, I think they believe that is what they’ll achieve.

Second
Because it’s my assertion that the 72 psPD arm still exists - and it is made up of only true pseudos, as that is what was intended, I also believe that the Company has continued enrollment on that specific arm. And while they built the arm of 55 of rapid progressors, they in turn were also building the arm of 72 true pseudo progressors.

So even while the trial underwent changes (an enrollment increase of 36, as well as p-value change from .04 to .02, and finally a PFS requiring only 4 months versus the previous 6 months), they were still enrolling in the trial during this period of time. Now I remember that some of us on this board had previously believed that trial enrollment would conclude around December 2014. If we were right about that, then that 72 arm theoretically, should have been filled by that time. I believe that’s why there is such a large position in the Jan 17, 2015 options. Many had hoped the trial would have been fully enrolled by now.

Third
If the 72 arm would have been fully enrolled by now, and the original 240 were enrolled by now, then we’d only have the remaining 36 to fully enroll the trial FOR EVERYWHERE BUT GERMANY.

If it takes approximately two more months to fully enroll the trial, that puts us at March 2014.

If the last patients enrolled require their final treatment on the 120th day, that’s another 4 months - or July 2014.

The clinical trials site states that the estimated primary completion date is September 15, 2015 - which is in keeping with with a full enrollment by July 2014.

In closing, while I’m not really sure if this changes anything regarding timelines, I did think it was worth considering. I’m just reading what the “words” say, and to me, they read the 72 arm is still in play. I acknowledge I could have missed some "words" - I just don't think I'm misreading the ones I've found.