Well Doc.
Seeing as you put it like that, this is my response.
And represents my opinion, which all are, of course, free to regard or disregard.
Regarding expansion at Sawston.
What we know is that it has effectively been in mothballs since they bought it in 2014, five and a half years ago.
A non-productive drain.
Yes, of course they realised some essential capital when Huawei came along. But they are still paying every month just to maintain the unused space that they lease.
Ever since 2014, I have looked forward to the time when it can be actively developed, and actually begin making DCVax product.
So I'm not going to start carping, when that day is now on a closer horizon. It was originally anticipated that it would become a licensed facility 2 or 3 years ago. But clearly they can only go as fast as resources allow. And they simply have not had the resources.
Disregarding the quality of the data, approval (in Europe or the US) for L simply will not be forthcoming without access to guaranteed scaleable manufacturing capacity.
Cognate is now independent and autonomous, though hopefully they continue to have some form of informal friendly alliance with NWBO.
They will only continue to reserve manufacturing space for NWBO if NWBO pays handsomely for the privilege.
That's fine if FDA approval is only a few months away, but unfortunately it isn't...
Should NWBO continue to pay Cognate indefinitely for manufacturing space that it cannot use?
As more lucrative work comes Cognate's way from other contracts, there will come a point when the arrangement to reserve space becomes progressively less tenable for both parties.
If NWBO believe they have found a route to manufacture in the UK, then I would say thank God and about time. They could not do it without Advent being in existence, and eventually manufacturing out of Sawston.
My opinion is, that on achieving the necessary licenses, they will initiate just as much capacity at Sawston as they need to service current UK Specials demand. I don't believe they have the resources right now to scale-up any further than that.
I believe they will endeavour to equip and make operational just as many cleanrooms as they need to manufacture for UK Specials patients, be that 3, 5, 10, or 20 patients a month.
If it was 10 a month, that might possibly translate to net revenue for NWBO of perhaps $5-10m per annum.
Which might just keep them alive, and allow Advent to survive at the same time.
Servicing UK Specials will, at the same time, be a very good test bed for establishing quality, failsafe manufacture, which is readily scaleable at the time when it needs to be.
Something the Car-T manufacturers didn't do very well at.
Look at the post-approval manufacturing problems Novartis has had.
As to the issue about whether Advent will prosper at the expense of NWBO and its shareholders, I would simply say 'ask me in a few years time'.
I don't have an opinion about it right now.
All I know is that NWBO will go nowhere without guaranteed access to manufacturing.
My own view is that LP and Co. are closer to achieving the impossible than ever before.
Why would I, or anyone, start carping now?
Regarding the ASM. Well, they've taken a gamble or a flyer with the 'interesting' adjective.
They have built up huge anticipation. Perhaps they would have been a little more temperate, had they realised how their words would be seized upon.
Or, they really do believe that they have major, substantive news to disseminate that fully justifies their use of the 'interesting' tag.
My guess is that they do have such news to disseminate.
And of course, I rather hope that they do.
And I anticipate a pre-ASM PR.
Because you and Umibe are absolutely right about the post-ASM market climate, if we receive a 'nothingburger' (to use an American expression).
But, I have my doubts about that news being topline...
I think significant 'business developments' are more likely.
Of course 'business developments' could mean anything.
I'm still thinking about what they might actually be, but I don't think they will involve Big Pharma.
I'd be happy to expound on what I think they might be, when I've thought about it a bit more.
I'm inclined to the occasional bit of levity in some of my posts, but I also put a lot of fairly serious thought (and work) into this whole scenario, and what might be ahead of us in the next 6 months. And I've tried to follow the UK angle, the UK/European regulatory scene, and developments with Advent ever since I first informed this Board of Advent's existence!
And I know that some other posters are aware of that and, I think, appreciate that.
And they also know when I'm lapsing into some pretty dire humour.
Regards.
AI
