NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Hi Senti.
Yes, I recall seeing that.
I ask myself ; what does 'more than 3yrs' actually mean?
And really, I think it only means 'at least 3yrs'.
Maybe they did a viability test that got to 3yrs and a couple of months, but no further.

If they had validated a shelf-life of 4yrs or just over, to the satisfaction of three regulators, then I think they would have said; 'more than 4yrs'.
So I still think my shelf-life theory is a possible (as reason for hold), though I'm not at all saying it is the reason. Rather it's just one of the more likely theories for me.

And I haven't discounted the whole 5-ALA fluoresced tumor tissue issue as another possible reason. They might have been required to do extended testing to demonstrate that L made from fluoresced tumor had all the same critical quality attributes as that made from non-fluoresced.

Again, just a possibility.
But on this one, if during the hold, they had scientifically proven by testing that fluoresced tissue was just the same, then although a pain at the time, it would have been very good to prove it during the trial, and before BLA or approval, so that after approval there is no impediment to treating patients who have 5-ALA surgery. And 5-ALA surgery might well be on the way to becoming the norm.

I know there are more positive theories about the hold (and more negative!), but I think my ideas fit the likelihood best for me.

Regards