RE: HeidHoncho 20.5429 Oct 2019 08:46
In the US, the Food and Drug Administration ("FDA" or the "Agency") requested additional information from Ichor Medical Systems ("Ichor") on the TriGrid® 2.0 electroporation delivery system. Whilst there has been extensive dialogue between Ichor and the Agency, a timely resolution to the device-specific questions has yet to be agreed.
In order to initiate patient recruitment in the UK under the Investigational New Drug (IND) application submitted to the Agency, prior approval of the IND is required. Having considered the ethical issues related to patients awaiting enrolment into the UK sites, Scancell has decided to withdraw its IND application in the US to allow the UK arm of the trial to proceed.
Has the US IND now been reapplied for? I dunno.... does it mean a going back to Go for timescale as in is it then treated as a brand new IND? I dunno..... Do we know did the Ichor part had to be withdrawn too? I dunno .....Has any timescale been given for US resubmission process ...no (probably a good thing considering lol).... Of course, the greatest outcome would be we get a few patients dosed soon in Notts and then US green light is given and most of the trial shifts back to US ...I am certain it is what scancell are hoping for but the FDA remains the unkowable stumbling block