Mani, I don't think IND's will be submitted on new trials until UK approval is in. I believe that the IND has a 60 day presumptive acceptance, then the IRB of the lead clinicians hospital must finalize the trial protocol, that can take a few months. If we don't get UK approval in the next month or two, unless a filing is made prior to the approval, it might not be possible to start this year, even if that's what they wanted to do.
I don't believe the company thought the UK would take this long when LP did her Annual Meeting nearly a year ago. I don't believe we'll get another meeting until we get the answer from the UK. I still believe that LP will have much to announce during the remainder of the year, but some things they hoped would be initiated this year may not be initiated till next.
I'm hoping we gain EDEN approval ASAP, I still believe it's the key to filing with regulators everywhere and none of that will occur until the company at least believes it's no more than a few months away.
If things go well between now and the end of the year I'd hope that we'll have filed for approval of DCVax-L elsewhere by the end of the year. I believe that we've learned much from the UK filing and all that's been learned needs to be incorporated into the 1.7 million pages that were submitted to the UK so the same questions never come up again. No doubt there will be new questions, but we shouldn't need to deal with any of the old ones again.
Gary
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