I believe they intend to PR the MIA, as they already PR’d the submission.
I posted the MHRA’s various pathways from their website and their explanation of how the ILAP pathway differs including expediting review by, for instance NICE, and bringing them in early. We all saw that NICE restarted processing out of the blue a few weeks ago. The reality is, because much of what we are doing is deducing status, I think the fact that these various processes seem to be happening concurrently, it suggests some sort of expeditious process is in play. Plus the requirements for the ILAP program coincide well with the DCVax-L story and also the enthusiasm we see in the UK from parliament to patient advocacy charitable organizations and the regulators.
It seems unlikely that they would not therefore be a likely candidate for ILAP which also puts them into contention for Project Orbis, and also the UK has a commonwealth set-up for their drug approvals with Canada and other countries including Switzerland (not commonwealth, but by treaty) and Australia, which is a commonwealth country.
We could see a lot of approvals, if all falls into line, fairly quickly and I cannot imagine that some BP does not already have an agreement based on milestones or is not circling them in private discussions. No one wants that to get out. They do not want a pop in price to blow the opportunity. Very likely in my view, the company seems likely subject to confidentiality agreements, but that’s just a guess. But when we see how quiet they are, I think there is no reasonable explanation that is not either illegal or a conspiracy theory, other than that they have some other things going on that they cannot discuss.
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