NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

See that sent? 348 main cohort. Also first time they mention the "secret" psPD randomized cohort, for which it seems they found an additional 32 patients (though they were aiming for 48/72), or 380 patients total.

Yes… you were right that the main arm of the trial enlarged from 240 to 348 by 108; and not as I thought from 240 to 276. Pseudos are 32, not 72.

Sentiment, flipper: "Hey Pyrr you were right about the trial being enlarged by 108 patients and not 36 too, proving Linda lied about that! You're amazing!!"

312 + 36 = 348. LINDA NEVER LIED so you can count on me not saying that.

And there you go with your “assumptions” again. We made both/all made assumptions based on what we had at the time, and not necessarily on what anyone told us. Linda just "told us" the new facts. We knew the trial was at 312 enrollment. They increased it by 36. End of story.

From August 11, 2104 Press Release

The bases for reducing the threshold from 6 months to 4 months difference in PFS include increasing the total number of patients in the trial from 312 to 348, and increasing the number of “events” that will be counted in the statistical analyses at the end of the trial.  An “event” is a tumor recurrence or a patient death.

www.nwbio.com/nw-bio-obtains-approvals-for-enhancements-of-phase-iii-trial-of-dcvax-l-for-gbm-brain-cancer/

With the short position in NWBO, anyone can see why the company may not have wanted to make it at all easy for someone to model the trial and predict when it might end. That might give a heads up to the shorts that it's time to exit their positions.

Now that the company has Woodford’s 100 million dollar patient support, perhaps they are feeling a little more confident about sharing the enrollment details with us of the main arm of the clinical trial, the pseudo progressor arm of the trial, and the sorting criteria of the Information Arm,… which I’ve finally gotten a chance to look at.

And if I’m reading this right, it looks like ALL of these Info Arm patients had 25% or greater tumor increase, or a new lesion of 1 cm. or greater at their first Baseline Visit.

And then those designated as Rapid Progressors look like they had DOUBLE THE INITIAL PROGRESSION to label them as Rapid Progressors. Now that is amazing!

That also means that those in the Indeterminate Arm also showed 25% or greater tumor increase or a new lesion of 1 cm. when they were initially placed in this arm.

Isn’t that what both MacDonald and RANO state to be considered “progression”?

http://radiopaedia.org/articles/rano-criteria-for-glioblastoma
http://radiopaedia.org/articles/macdonald-criteriafor-glioblastoma

Progression
• imaging features
? 25% of more increase in enhancing lesions
? any new lesions
• clinical features
? clinical deterioration

Now if I recall correctly, I think my new well-mannered sparring partner AVII said that those patients started receiving DCVax L after entering into the Info Arm.

That means that all those patients had been on DCVax-L during the 2 months after their Baseline Visit and prior to this Month 2 scan, and had ALL received at least 3 treatments. And yet… those 20 Rapid Progressor patients had still actually progressed beyond what they’d shown at the Baseline Scan. While on L. It's kinda hard to deny those 20 weren’t ALL rapid progressors.

And 25 patients had actually stablized or had less than 25% growth in addition to what was seen on their Baseline MRI, after having been on DCVax-L for 2 months.

I wonder, do most GBM patients that initially show progression… and then have what showed as progression disappear (that’s what happens with pseudo-progressors, right?)…usually also receive about 3 treatments of L during the first two months after receiving 6 weeks of chemo and radiation?

No.

But in this arm, one did. The “confirmed pseudo-progressor” did - see that note on the poster? “1 patient had all original 25% increase gone at Month 2”.

And I think any one would agree that those 25 Indeterminate Progressors were perhaps just that... Indeterminate... because they were beginning to respond to the three treatments they'd received during that two month time period, leading up to the Month 2 MRI that sorted them.

You said…

I said they are reportedly worse, if one took literal what Linda Powers was saying at every conference, that the "sickest of the sick" had a mOS of 18 months, compared to 7-10 months for historical control. Well, now we know it's down to 15.3 months, and even that is a maybe, as no follow up scans were done at 6-months to further clarify who were psPD and who were ePD. The long tail in that ePD cohort might actually be psPD then.

First, you are twisting her words. She was referring to the entire group of 51, not the Rapid Progressors alone. And 15.3 is impressive, for Rapid Progressors. It’s 5 months longer than the best these rapid progressor patients can hope for - 10 months.

Second, you are assuming... again... when you state they didn’t review these patients at the 6 month scans. You have no idea if “THE INDEPENDENT MEDICAL IMAGING COMPANY” that initially did the sorting, didn’t re-sort a few of these patients at a slightly later point…say the 6 month mark. You know full well that scans were done every two months - the two patient consent forms demonstrate that. The poster is showing, however, how these patients presented two months after the Baseline visit, done after receiving intensive chemo and radiation. That MRI definitively ruled you in or out for the main arm of the trial. The Month 2 MRI appears to be the primary source used to sort the patients.

I don’t think you are being fair here. You are asking for a give on the 108. Fine… I give. With Canada on board, and Woodford's funding, I doubt it’ll make a difference in timing. Clinical trials still shows Estimated Primary Completion Date of September 2015.

But you are not giving on the info arm. These patients were the sickest of the sick to start with. Some responded better to the at least 3 vaccines of DCVax-L than others given in those first two month, resulting in them being sorted into the Indeterminate Progressor group. The Rapid Progressors are… Rapid Progressors. I'd like you to now admit these were the "sickest of the sick". Oh... and that Linda was not lying when she said the trial increased by 36.

I will wait with “patience” for your give.