Replies to post #170375 on NorthWest Biotherapeutics Inc (NWBO)

[iwasadiver]

Thank you

[photonic5]

Thank you Ike!

[Pablosrv]

Thanks. I should forget about this for another year and a half I suppose. Right?

[Etienne1]

Thank you Ike and Beartrap too!

[MI Dendream]

Thank you Ike,

What I Would like to see done is that this Spring data look provides confidence to start unblinding to quickly go next to top line reporting. This would mean based on the comments from Q&A that we could get the early top line results by Mid July. What in my heart I know will happen is that the ball will get punted to Fall/EOY reporting.

Ugggggh

[Sojourner55]

Thank you IkeEsq. Safe trip home.

[sentiment_stocks]

Thanks for the very thorough update Ike.

[manibiotech]

So no approval till next year seems like

[hankmanhub]

Ike, thank you very much for the info and your effort.

You wrote:

"Do they have a count on the current number of patients alive?

No. They are doing the data collection now, in the early stages. This requires the staff of the CRO to physically visit each of the 80 centers and verify hardcopy records against the database and figure out the discrepancies. All of this is done by the CRO, not by NWBO."

Why on earth should determining whether say 2 to 20 more patients have died during the latest period of the trial during which deaths have not yet been tallied. A bright high school student should be able to tally the number of new death certificates for those who died in just a couple of days or less - leaving any other data issues for others to tally that may need more time!

[CaptainObvious]

Thank you VERY much, IkeEsq

[biosectinvestor]

Thanks very much Ike!! That’s fantastic news!!

[Lykiri]

Thank you IkeEsq! Wish you a nice weekend!

[dude409]

Ike, big thanks to you and beartrap. Great info.

[Doc logic]

IkeEsq,

Thank you for attending the meeting and helping to keep us up to date with responses to enquiries. Best wishes.

[CherryTree1]

Thank you very much for the meeting summary . . . greatly appreciated

[learningcurve2020]

Publish in a learned journal as she continues to dilute and can place the blame elsewhere.

No offense but don't believe a thing until she speaks with all shareholders on a q&a cc. Tired of the messengers.

[Poor Man -]

Thanks Ike and Beartrap for the update. Wish I had an opportunity to attend to ask some questions about the status of financing, especially in light of the longer time horizon for the unblinding of the data.

[eagle8]

Thank you IkeEsq and beartrap for attending the meating and sharing with us!

GLTU

[HappyLibrarian]

They all but said it: Spring 2019 before unblinding.

We are going to get destroyed by another year of waiting.

Yearly data collections may be “sufficient” for NWBO management which can use tricks to mitigate the impact of dilution on themselves but not for retail shareholders.

Knowing NWBO’s history it is obvious there will be no data collection in the Fall and no unblinking and thus no real relief for shareholders:

Is data collection only an annual thing or could it be done more frequently?

It can be done more frequently but it is expensive, time-consuming, and hard on the sites. They are finding yearly collections to be sufficient. They have not ruled out doing one in the Fall.

[Bigmahalo]

Thank you for taking the time to attend and your recap.

[Evaluate]

Right-to-try is looking promising.

How soon could DCVax-L become available for Right-to-try? Well prior to DCVax-L receiving full approval, right? Could the blinded publication (with blended data from 2017 Spring refresh) be instrumental to help DCVax-L receive right-to-try eligibility?

Do they have a count on the current number of patients alive?

No. They are doing the data collection now, in the early stages. This requires the staff of the CRO to physically visit each of the 80 centers and verify hardcopy records against the database and figure out the discrepancies. All of this is done by the CRO, not by NWBO.

This is surprising to me, in that a Survival/Death event is pretty straightforward. And it would seem that it would not require the staff of the CRO to go visit 80 centers ... to confirm how many patients have died and how many are still alive. Plus .... when Dr Bosch indicated in June 2017 that the trial was just a few patients removed from crossing the OS threshold, and indicated a relatively specific current OS eventing rate .... this would seem to indicate he had very recent info on hand (of course this could coincide with the Spring Refresh ... perhaps being completed from March to June 2017 timeframe?). Still, I would have thought that NWBO would have had a pretty good idea about the blended number of OS events during the full duration of the trial.

Seems like NWBO wants to see the long tail, but they find the number of OS events (or number of remaining patients alive) not that significant? Seems like there is a relationship between these 2 sets of statistics (more patients alive for a longer period of time would result in a better long tail).

How long does unblinding take?

Unblinding and data-lock take longer than the data collection (which is around 12 weeks). Asked about 8-10 months, not that long.

So data collection takes about 3 months, and unblinding and data-lock takes somewhere between 3 months and 8 months. Perhaps say 6 months?
And it sounds like the 2018 Spring Refresh has just started .... so might take until June 2018. Would one then need to add around 6 months .... until about Dec 2018 ... to arrive at the earliest expected timeframe for unblinding & data-lock?

Is data collection only an annual thing or could it be done more frequently?

It can be done more frequently but it is expensive, time-consuming, and hard on the sites. They are finding yearly collections to be sufficient. They have not ruled out doing one in the Fall.

Why would they not have ruled out a Data Collection in the Fall? I would suspect the only reason would be if they feel that the data from the 2018 Spring Refresh gets them very close to wanting to move forward with unblinding, "but not quite". Then it could make sense to wait for less than the current 12-month data collection cycle (despite the "high cost"). And I assume that the "high cost" of data collection is relative to the "high cost of further dilution" from additional needed financings while waiting for the next Data Collection.

[flipper44]

How long does unblinding take?

Unblinding and data-lock take longer than the data collection (which is around 12 weeks). Asked about 8-10 months, not that long. -- Ike's April 2018 meeting NWBO notes.

Data collection probably started about April 5. July 5 = 12 week (three months). September 5 = 5 months. November 5 = 7 months.