So RK please explain your earlier post to your latest analysis of 3 years past last enrollment. I think you need to re-assess as you are dead wrong if you think that this company can limp on for another year without proving anything to it's investors. They may continue to collect data but after all that has been said and posted by the company this year I cannot believe they will not unblind until Nov 2018.
Your previous post as follows.
The Company does not have the money to continue the trial another year for those last in after locking and censoring the trial data. The Company has the right to end the trial any time they want to, for any reason. And so, it is quite possible that they are tying data lock with the conclusion of study end and that is why we are not being told what is going on.
If they learned in August that the trial reached the 233 in July, as they anticipated, then I would imagine that that is the point the trial clinical site investigators would be told, by their CROs, to get the last MRI on each remaining patient in the study, and conduct an end of treatment visit. The trial is meant to be 3 years from enrollment for patients who are alive that have not crossed over. The Phase III consent forms makes it clear that each patient must go through an EOT visit at the end of the 3 years (36 months in).
"18. STOPPING THE STUDY The sponsor may decide to stop the study at any point, for any reason." -- protocol
I truly think it is not reasonable to expect a virtually bankrupt company to continue to fund a trial that is about to be censored upon data lock for another year plus. Long tail follow-up is still on-going and can still be done on their study if it is ended early. But if they do decide to end early, further injection treatment schedule would not be followed. And so it's quite reasonable to believe they may be extending their right to end the study a year early for last in patients upon considering both the primary and second Endpoints are crossed.
If NW Bio decided in August to data lock survival, it still may mean the trial can run into November as they attempt to line up data lock with the study ending after 2 years after the last enrolled patients. End of study (EOT) visits require that each patient undergoes an MRI, which are conducted every 2 months, plus or minus 14 days at this point. Ensuring each patient undergoes their final MRI is a process is a multi-month. And then remember, some of those visits will coincide with scheduled injection treatments. The last DCVax-L injections may still take place. And so then one more additional month of 30 days follow-up would be needed to record tracking information on AE.
From the protocol:
"8.5. END OF TREATMENT (EOT) VISIT SCHEDULE AND PROCEDURES (ALL PATIENTS – RANDOMIZED AND CROSSOVER): • EOT Visits for all patients who discontinue from the study should occur at least 7 days, but ≤ 30 days, after the last immunization and prior to beginning other treatment. Procedures to be performed during the EOT Visit include: • Physical Exam • Neurological Exam • Vital Signs • KPS • MRI of brain • CBC and Differential • Blood Chemistry - Comprehensive metabolic panel, including electrolyte balance, and hepatic and renal functions • Serum markers of Autoimmune disease (anti-DNA) • Urinalysis • AE Assessment • Concomitant Medication" -- protocol
Also note this from the protocol, 30 days after the patient exits from participation in the trial or last study treatment, (whichever comes later) tracking information on AE is still necessary:
"Study-Specific Adverse Event Recording • The time period for AE assessment starts at pre-leukapheresis through 30 days after the patient exits from participation in the trial (off study date) or last study treatment, (whichever comes later). It is recognized that the date the patient is determined to be “off-study” may not coincide with a visit date. " -- protocol
And:
"13.3. RECORDING AND FOLLOW-UP OF ADVERSE AND SERIOUS ADVERSE EVENTS All AEs that occur (or that worsen from pre-leukapheresis status) from preleukapheresis through 30 days after the patient exits from participation in the trial or last study treatment, (whichever comes later), will be recorded. Adverse events that occur after enrollment but before the first immunization will be considered not related to study drug. Duration, severity, and outcome for each AE will be recorded on the CRF Adverse Event Form, and treatment administered for the event will be recorded on the Concomitant Medications pages; this information must also be recorded in the source documentation. Adverse events will be followed until resolution, until no further improvement is expected, or until the patient is lost to follow-up, whichever comes first." -- protocol
If they were to decide to treat overall survival secondary endpoint crossing as news that would start the process for conclusion of the study (verses going the full 3 years - November 2018), that would mean treatments would stop upon final statistical analysis. In short that would leave Sept and October timeframe to conduct all final visits and then November to undergo the 30 day AE follow-up. Again, considering they have the option to end the study at any time over any reason, it may be necessary that they do so because of funds; and therefore, they are tying up all loose ends, and plan to conduct the final analysis once all patients undergo an end of treatment visit (albeit earlier than the 3 years for the last enrolled patients) and all necessary follow up is complete. And we won't hear about it until it is done.
You may ask why I believe this might be the action they are taking? Well, because the clinical sites are in the process of gathering information for a review paper that can only be released once the study concludes. And it is also quite possibly that the Company gave the okay to begin the process of ending the study, with a specific trial end date in mind, a couple of months ago.
From the protocol on publications:
"The Study is designed as a multicenter study and not powered for analysis and presentation of Study results by individual Study sites. It is anticipated that the final results of this study will be submitted to a peer-reviewed scientific journal. Authorship on such a paper will be acknowledged with customary scientific practice. As such, without the expressed permission of the Sponsor, only clinical Study data relating the Study as a whole will be published. If permission is granted by Sponsor for publication of ancillary data from individual sites, prior to submission for publication of any manuscript or presentation of any poster, presentation, abstract or other written or oral material that describes the results of Study, Institution and/or PI shall provide Sponsor at least 60 days (or as otherwise specified in the sites executed Clinical Trial Agreement) to review any such materials. Such materials shall not divulge any of Sponsor’s Confidential Information, and Institution and/or PI shall promptly remove any Confidential Information as requested by Sponsor. If requested by Sponsor, the PI and Institution shall delay the submission of any publication or presentation up to 60 days from the date of Sponsor’s request for such a delay. In addition, Sponsor has the right to require that any publication or presentation concerning the Study will acknowledge Sponsor’s support." -- protocol
Time will tell if they continue the study after overall survival data lock. But my bet is that they will end the overall Phase III study at the time they conduct the final analysis. And I sincerely doubt we will be waiting until November 2018 (the full 3 years after the last enrolled patient) for them to do so. I think they are in the final stretch, now.
Consent form is for 36 months after enrollment. End of trial is considered 36 months for non-crossover patients.
"The duration of your participation in this study is approximately 36 months. Long-term follow-up may be beyond the 36 months of the clinical trial. Your participation in this study is entirely voluntary. You should read the information below, and ask questions about anything you do not understand, before deciding whether or not to participate. " -- consent form
"All subjects who have undergone the leukapheresis will receive up to 10 injections of the study agent or placebo over the course of 3 years, except for those patients for whom it is determined that it is not safe for them to receive either treatment. All patients in the study will be followed for the collection of data related to progression or re-growth of brain cancer, and survival for a period of up to 36 months. In addition, long-term progression or re-growth of your brain cancer as well as survival, or overall survival will be followed beyond the 36 months of the clinical trial." -- consent form
See page 14 for treatment MRI visit up to 36 months post enrollment.
We've all seen this below many time. Their are still enrolled patients who potentially have not received their last consented dosage.
"Prior to the last dose of the last patient enrolled in the Phase III trial for DCVax®-L or After the last dose of the last patient enrolled in the Phase III clinical trial for DCVax®-L but before any submission for product approval in any jurisdiction or after the submission of any application for market authorization but prior to receiving a marketing authorization approval: in any of these cases, the fee shall be $3 million." -- 10Q
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