A few thoughts19 Aug 2019 15:34
Lots of conspiracy theories today, 'cover ups' and deceit to the fore - all understandable, but isn't it reasonable to set your plan out and stick to it - i.e. the US and UK arms of the trial were proposed, and the data would presumably have been gathered and shared simultaneously. The IND was submitted in the US, and preparations in the UK being done, no reason to suppose that the planned timescales wouldn't be close enough to keep them synchronised.. The IND then gets delayed (or obstructed, depending on how you think) but preparations continue in both countries. Eventually it gets to the point where the UK trial is all set and ready to roll (as we were told), patient recruitment under way, and the hope is to get the IND cleared in a few weeks. Then it gets to a point where you go to Ichor and say 'look - we're all ready to roll, is that IND issue going to be resolved in the next few weeks (or couple of months) or not? Because we have a valid trial ready to go and it makes financial and scientific sense to crack on alone if the US arm isn't going to step in pretty quickly.' Ichor then identify or are told of a substantial further hurdle from the FDA, and the decision is taken to separate the trials and progress the UK one because patients are deteriorating or dying due to an administrative delay. The data to be gathered will be internationally valid, the patient numbers are sufficient, and what's to be gained by waiting an indeterminate length of time to accommodate a useful but far from essential US study? Don't forget, Keith Flaherty was perfectly happy with data from the SCIB1 trial that was wholly UK conducted. Also, since the original proposal of the SCIB1/Keytruda study, Scancell's links in Europe have been transformed, arguably making them far less reliant on forging contacts in the US - don't get me wrong, US links are very useful, but they are not essential. Why weren't we given a heads up? Because you don't put out an RNS saying 'the IND looks to be dragging even further, we might quit that side of things entirely but a lot depends on the next few weeks', because you might, you might not, and until you have made the firm decision to abandon the US then what is to tell? I also remember LD at the 2014 AGM talking of witnessing the grotesque side effects of some of the then-current treatments - she was genuinely shocked by them and keen to develop treatments that were more effective and kinder to the patient. I can see her hand being in this decision too - why wait an indeterminate further time for the US when we can make this trial start here, and get valid data to prove what we want to prove? Imo the patients are literally waiting for the go-ahead, and they now have it. Wouldn't surprise me if the first one was injected this morning to be honest, but we'll just have to see what happens next.