Replies to post #285783 on NorthWest Biotherapeutics Inc (NWBO)

[Bright Boy]

All of this constant back and forth on this board regarding timing of the Data lock ..... ignores the fact that Northwest's wonderful discovery is saving and extending lives everyday in the UK under the UK Specials Regulation provisions. Guess what??? Although under UK regulations, Northwest cannot use the same name that is used in the US Phase III clinical trials(DCVax-L), it is the same drug/vaccine and the acronym is ADCV for Autologous Dendritic Cell Vaccine. The vaccine is manufactured by Advent on a private pay basis!!!! With the real time success of ADCV, the demand is skyrocketing !!!! SO the efficacy of the vaccine is validated everyday in a country where highly enlightened decisions affecting human life far surpass anything that is presented by the US FDA. People that are affected by GBM are flocking to the UK for treatment of GBM. This vaccine is already validated. What the hell difference does it make if the company is a few days off, one way or the other on reporting Data Lock and TLD. The best example of Top Line is the line of success resulting from real life, real time use of the vaccine in the UK. If a US patient diagnosed with GBM wants to extend life and possibly remove GBM from their system, they'll travel to the UK for the private treatment, irrespective of Data Lock or anything else. Wake up, people!!!! Therein lies the value of DCVax-L and that value is definitely not determined by DL or TLD!!!!!!

[longfellow95]

Hi Doc.
I'm afraid I don't consider it a 'voluntary' hold..
Whatever it was called, I'm of the view that it was at least a de facto mandatory hold.
It was only lifted when the FDA decided to lift it!

But yes, the 5-ALA theory doesn't obviously jibe with the probability that the last 30 or so patients all went to treatment.
(Though it remains possible that the randomisation skew could have been introduced at a different time, or for a different reason.)

I'm not asserting that this was the cause of the hold; just that for me, it is up there as one of the more likely possibilities.
As to it being a continuing hold, I think that fits quite well with some sort of required equivalency test or perhaps a related shelf-life test, which would necessarily take a long time to perform.

Even if ultimately it has no bearing on trial outcome, I would like to know what the hold was about..
I'm just so damn curious about it!