When the trial referenced 11 patients enrolled in 2008 SEC documents in the double-blinded trial, in my opinion recruiting stopped there. The study stopped enrolling in late 2008. And from SEC statements it was clear funds were an issue. It has always been that those were the only patients from the 2011 May PR (33-patients) in the double-blinded portion of the main trial arm prior to 2011.
The other 11 patients is from the 2007-2008, enrollment potion when the trial was an open label. That portion of the study is part of this NCT number. But, those patients events are not part of the statistical analysis.
The last 12 patients were in the trials information arm, as it enrolled rapids separately, even in an open fashion. Anyone who looked like they were going to be progression, were removed from the open label trial.
Here is a portion of the SEC statement, makes it clear enrollment was limited to the period in 2008:
NW Bio has primarily been enrolling its Phase III trial since Q2 of 2011. The Company undertook a limited period of enrollment in 2008, and then kept the trial going with the patients already enrolled, but suspended new enrollment due to resource constraints during the worst of the economic downturn, through the end of 2010. The Company began the process of reactivating clinical trial sites for new enrollment in Q1 2011, and resumed screening in Q2 of 2011.
And here are the two statements again, the first a PR and the second a SEC statement, in which 33 patients count grew by 1:
"NWBO May 2011 Enrollment PR: "To date, 33 patients have already been enrolled in this ongoing 240-patient GBM brain cancer trial and its information arm an have been proceeding through the treatment regimen and follow-up.”
And then a later PR statement:? SEC statement 2011: “The Company has already enrolled and treated 34 patients in this Phase II trial, including 22 patients in the trial arms and 12 patients in an information arm and the company has similar number of additional patients in various stages of the screening and enrollment process”
Notice this line?:
"Including 22 patients in the trial arms"
When I see arms I see: Open arm. And Double Blinded.
Notice this line?:
"12 patients in an information arm"
To me that means the Open & Double Blinded Information Compassionate Use Arm: Note, 11 of those 12-patients were enrolled prior to 2009 and 1 would make it into the 2011 -2012 Double-Blinded Compassionate Use Info Arm
(Also note, that one extra patient (when the count grew from 33 to 34) could be enrolled in the main arm and that would just mean 1 less patient in the Open arm.
Remember the company had originally planned to enroll 141-patients as an open trial, 2:1 randomization with no placebo. That 141-patients protocol still removed rapids and psuedos. And remember we were never shown survival data of any an information arm from the pre-2009 period. And also recall that the study screened almost 50-patients, before stopping to design a placebo. It is not unreasonable to imagine that from 50 screen 22 would end up in the vaccine cohort of that open arm (open arm and its own information arm). "
See SEC below ("" all from 2008 10K):
"SEC 10K 2008 Statement: The study was not blinded because there was no available approach for making a placebo that was indistinguishable from the DCVax®-L. Almost 50 patients were screened at 4 clinical sites. However, patients were reluctant to enroll in the study when faced with a 33% chance of being randomized into the control arm of the study under which they will receive standard of care alone. "
"Following up on these results, in 2007-2008, the Company designed and began a 140-patient randomized, controlled Phase II trial but without a placebo and without blinding (which can only be achieved with a placebo that is indistinguishable from the new treatment being tested), as no placebo then existed for a living cell product like DCVax. Unfortunately, without a placebo and blinding, patients who were randomized to the control group in the trial knew that this was the case – and, not surprisingly, they tended to drop out of the trial. As a result, that 140-patient Phase II trial had to be stopped and a placebo had to be developed to enable blinding, so that patients would not know whether they were receiving DCVax or a placebo."? "We obtained a new FDA clearance and re-approvals by all the clinical sites, and commenced the new Phase II trial in early 2008. Unfortunately, we had only been underway for a short period when the economic crisis hit. We were able to keep the trial open, and continue treating the patients already enrolled in the trial, but we had to suspend new enrollment of additional patients into the trial. This suspension continued through the end of 2010, solely due to the severe economic downturn and resulting resource constraints."
And so, Eleven is fairly accurate for the time in 2008. No patients in 2009.
And I can prove some of the 33 we're open and compassionate:
"On June 3, 2008, The Star Ledger quotes, Dr. Gruber, the Phase II, Procotol 020221, Lead Investigator, of Overlook Hospital and NYU, as saying, “Overlook is running the the trial in conjunction with NYU and so far has enrolled 20 PATIENTS”.
The trial only opened in May 2008, enrollment is not that quick. Notice, that SEC the blind portion drops to SIX:
"On August 19, 2008, in an official SEC 10Q document, pasted above, NWBO reveals enrollment to date on that Phase II double-blinded as: "to date, ONLY 6 PATIENTS have enrolled in the clinical trial”, and “given our CURRENT lack of funding it’s unclear how quickly, we will be able to increase enrollment, if at all.”
"On Sept 4 2008, a Nurse Blog is written about Kathy Montag’s GBM story, with the Nurse’s Connection, Overlook’s enrollment count specifically in the Phase II is at 3 PATIENTS. In June the count had been at 20. In September 3. At minimum, the 17 patients to which Dr. Gruber referenced would be patients enrolled into 141-patient trial. "
Here is the rough trial timeline for that period: — NCT # open 2006; same # continues today -- Open randomized study began in 2007 without placebo; In December 2006, we commenced recruiting patients with newly diagnosed GBM in a 141 patient Phase II DCVax-Brain clinical trial-- Four clinical sites, screened roughly 50 patients; Recruitment in control arm poor due to patients knowing classification, control patients dropped out per 2007 10K (repeated 10K verbiage subsequent years: 2008, 2009, etc.) -- Four sites, screened roughly 50 patients Recruitment in control arm poor, patients dropped out -- recruitment stopped in 2007/2008 and company developed a placebo; obtained renewals of institutional review board or IRB approvals and other necessary steps; reinitiated approvals at all clinical sites, approvals granted. -- Kathy Montag surgery in December 2007; joined DCVax Ph II Double-blinded study but didn't get vaccine until April/May 2008 -- Double-blinded study PR to start in May 2008 -- Dr. Gruber, Principal Investigator for NYU and Overlook quoted stating in the Star Ledger in June 2008 “Overlook is running the trial in conjunction with NYU and so far has enrolled 20 patients.” [his statement must include open label + open CUA - rapid-progressor patients] -- June 2008 10Q, released on August 19, 2008, company quoted as "to date only 6 patients have enrolled in the clinical trial, which is designed to include 240-patients. Given our lack of funding, it is unclear how quickly we will be able to increase enrollment, if at all. unsure if they could enroll more, financial constraints. — August, 19, 2008, 11 active sites -- Nurses blog in Sept 2008 story on Kathy Montag, Overlook Nurse, as that time Overlook reported to have enrolled 3 patients in Double Blinded Phase III since it began [a drop of 17 patient count from Dr. Gruber's June statement]. -- Sept 2008 10Q released on November 19, 2008, again company quoted "to date only 11 patients have enrolled in the clinical trial, which is designed to include 240-patients. Given our lack of funding, it is unclear how quickly we will be able to increase enrollment, if at all." -- January 2009, 13 sites are qualified and ready to enroll [but “ready to enroll” with no money, meant, enrollment was open in “name only”. ] -- NCT site records recruiting as stopped mid-year 2009
And then their is this in 2013, which confirms no enrollment in 2009:
March 2013: NW Bio provide guidance on trial enrollment.
"NW Bio expects to complete enrollment in its phase III trial by Q1 or early Q2 of next year – an overall enrollment period of 14 or 15 calendar quarters, including both the 2008 period and the period since Q2 2011". --March 7, 2013
"June 2008 10Q (released on August 19, 2008): "to date only SIX patients have enrolled in the clinical trial, which is designed to include 240-patients. Given our lack of funding, it is unclear how quickly we will be able to increase enrollment, if at all. unsure if they could enroll more, financial constraints.”
Sept 2008 10Q (released on November 19, 2008): "to date only ELEVEN patients have enrolled in the clinical trial, which is designed to include 240-patients. Given our lack of funding, it is unclear how quickly we will be able to increase enrollment, if at all.”
And that means two quarters in 2008: 11 patients:
And from the remaining 22 patients unaccounted for, that leave 11 open label and 12 CUA open label patients.
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