1) the relevant and largest parts of an application for approval are already pending with at least one regulator and given the nature of new rules, likely multiple regulators, a key indicator;
2) if the UK regulator applies its ILAP rules here, which DCVax-L clearly fits into, then it is likely DCVax-L can fit potentially into a rolling approval framework, which would mean, yes, they very possibly could already basically be pending approval;
3) the MHRA otherwise follows EMA rules until the end of the year, other than their special programs, so approvals by MHRA are likely at EMA, though EMA is a little slower. More importantly, the EMA has unequivocally approved the updated SAP as per the clinical trials website, which unlike the US, the regulator maintains.
4) the EMA is ahead of the US on some of these reforms as is the MHRA. The prior indicia of approvals of the updated SAP’s show a less inhibited communication of new rules though the article by Richard Pazdur on ECA is quite unequivocal.
Those are the facts.
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