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Re: IkeEsq post# 170375

Sunday, 04/29/2018 1:46:41 PM

Sunday, April 29, 2018 1:46:41 PM

Post# of 823776

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.

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