I don’t think freezing and transport represents the issue you think it does. Many cell based companies have been in business since that trial started and much improvement has been accomplished in terms of transport of and manufacturing of product in far off locales to then be transported to the US and vice versa.
I expect the comparability is likely well under way on those issues if there even has to be any done yet. But I am not skeptical at all that manufacturing for the US can be done in the Uk and vice versa, in the US for the UK or Europe, or Canada.
Do think that of course the issues around redundancy will be an issue. I do not think there will be questions about the viability of manufacturing either way. The point about transport of the product is a good question, though I doubt their earliest version is likely where the product is at this stage in terms of movement of product across and Dr. Toms’ statement of how it will work is exactly what they likely have in operation now for the Specials program. I doubt he just spoke off the cuff. He’s a careful man and I am sure he likely said what he meant, as also do I expect LP did the same.
I also watched the disclosures related to this issue, typically in the manufacturing and regulatory risks section. I think the regulator does want redundancy. I do not think NWBO will permanently or necessarily even beyond intial requirements, focus on scaling primarily through CRL.
I have said all along that CRL would be part of their plan, I explained the remaining parts of their original agreement, that they would necessarily be a part of the initial process. But NWBO has its own factory and cutting edge technology that it expects to implement there. They also need to protect that technology and giving it to a third party CDMO outside of their own factory is a risky proposition that puts critical commercial advantage at risk. A CDMO was without question seek to reverse engineer or utilize that equipment for other clients, and doing so outside of the company’s control would be worrisome.
It might be possible they could get royalty income, but again, the issue of IP protection for DCVax-L is still at risk since the primary protection is process patents.
Flaskworks becomes a serious advantage. If they license it away, the IP advantage rapidly evaporates. It sounds good, but rarely do such licenses benefit the out licensing party that much. The income is typically de minimis, it would probably be some millions up front and then a royalty on the manufacturing revenues after costs. That business sucks to be in, it would be nothing. Much would be given up for very little in return. Better to turn Sawston into that location, if they wanted f enter that business, but even then, not ideal to be in that business, but at least they would protect their trade secrets, ability to continually improve the technology with full ownership of such improvements and maintain a considerable commercial advantage in this particular area.
Now, they also might use CRL until they can construct a 2nd factory in North America owned by NWBO and maintained by either the company or Advent.
But the key, in my opinion, would be to keep that IP tightly held. Otherwise with an autologous cell treatment like this, the IP is not all that easy to keep proprietary.
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