Hi hyperopia. I have enjoyed many of your contributions, by the way.
Thanks for the link. Yes, I've seen it, but not in recent times.
So it's good to have a refresher.
I would say this falls a little bit short of actually explicitly declaring that shelf-life is fully validated to the satisfaction of regulators for 5yrs or more.
I'm coming from a position of half-expecting regulators to come up with 'issues' possibly somewhat spurious, or 'seeking confirmations' or nitpicking queries at any stage. So sometimes NWBO might think that they have already demonstrated something to a high standard and to regulator satisfaction, only to then find the regulator looking for even more in the way of confirmation. So I think that this might be a process in play at every stage. And I have the BLA in mind as something that, however rigorous and exhaustively comprehensive their application is, the regulator will find something requiring them to go back and compile additional information for submission.
I'll happily acknowledge that shelf-life might not be the issue at all. It's just a possible for me, and I don't have any particular investment in the idea.
And maybe spending time on trying to identify the reason for the partial hold could be seen as a bit of a fool's errand anyway, because where does it get you, when you want to have a basically forward-looking perspective?
On the other hand, trying to second-guess what might be going on behind the scenes on any issue or at any time and doing a bit of dot-connecting might add to one's own subjective investment hypothesis. And you don't have to influence or persuade others, when you are just developing your own hypothesis.
Which is different to concerted pumping or its opposite.
It's part of the fun I guess, just to share ideas and debate with others.
Speaking of which, do you have any thoughts on the hold?
