Replies to post #84833 on NorthWest Biotherapeutics Inc (NWBO)

[Rkmatters]

We do not know if the 248 primary endpoint has been breached as of today. But I do think it is safe to assume that by the October update that it implies that the the 248-patient event had not been crossed. You're welcome to disagree for any rhyme or reason.

The company received a shareholder inquiry last year about the PFS primary endpoint clinical trial registry change. At the time the Company updated the data collection date to Sept of this year (plus a month of delay for new screening) which would mean Oct 2016. The Company is also on SEC record in August 2015 stating that over 300-patients are enrolled into the main trial arm. And so there is nothing they can do to slow down events. Over 300 patients were on protocol. If the reached the 248-patient events last month, then there would have been no good reason to push out the "primary completion end date". But hey, that's just me.

Northwest Bio - SEC statement on 10-8-15:
?
Shareholder inquiry: What is going on with the change in completion date of the Phase 3 trial on clinicaltrials.gov? Is there a new change or delay in the trial?

Company answer: No, there is no new change or delay in the Phase 3 trial. In all of our public presentations all year long, we have stated that we anticipated finishing the recruitment this fall, and reaching the primary endpoint around approximately the end of summer or September of next year. The clinicaltrials.gov profile was very out of date, and the change of date in that profile from September of this year to October of next year simply conforms the clinicaltrials.gov profile to the information we have provided publicly all year long, plus about a month of cushion to take account of the temporary hold on new screening for the trial as we announced in August.

We are also updating the profile to correct the number of patients. As stated in all of our presentations for over a year, the total enrollment will be 348. The clinicaltrials.gov profile was very out of date in listing 300. We will simply be conforming the number in the profile to the number we have long presented publicly.

[Evaluate]

You wrote:

... Primary completion date mean, the estimated data for last patient to collect in Nov 2016. So that doesn't tell you whether the 248 events occurred or not. Isnt it ?
its not clear to me what data we are waiting for ? PFS or OS data or both ?

Did you take a look at the european trial register - Section E.5? ... see link below.
The trial is designed with PFS as the Primary end point, and "Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated when 248 events of progression or death have occurred"

Below you will also see info about the Secondary end point, Overall Survival, and "Timepoint(s) of evaluation of this end point
Overall survival will be assessed when 233 deaths have occurred."


https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/DE

E.5 End points
E.5.1 Primary end point(s)
Time to objective demonstration of disease progression or death,
measured from time of randomization (progression free survival, PFS),
in patients with no evidence of disease progression after external beam
radiation therapy with concurrent temozolomide chemotherapy.
E.5.1.1 Timepoint(s) of evaluation of this end point
The primary endpoint will be evaluated when 248 events of progression or death have occurred. in addition, two interim analyses will evaluate the endpoint when approximately 60% and 80% of the events have occurred.
E.5.2 Secondary end point(s)
Overall survival: In patients with no evidence of disease progression after external beam radiation therapy with concurrent temozolomide chemotherapy.
E.5.2.1 Timepoint(s) of evaluation of this end point
Overall survival will be assessed when 233 deaths have occurred.

And the USA clinical trial site shows:
https://clinicaltrials.gov/ct2/show/NCT00045968

Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

So, unless some of the protocol has been changed without public knowledge, then it would appear that the estimated Primary Completion in November 2016 (at least the "Final data collection date for primary outcome measure") only relates to PFS, and has nothing to do with the secondary endpoint of Overall Survival.