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At least it confirms that the impasse is around ichor and nothing to do with the scancell science.
Does anyone think there is a possibility of some US patients getting on the UK trial?
It will only be positive if US arm is not still hanging over us... really like I say they may as well all but abandoned US arm and stated more patients as in the full amount planned for trial will be recruited in the UK...
I think the huge cost savings will be positive for the share price once investors have had time to think it through fully
Yeah which is why... reluctantly I think they may as well ditch US plans and up recruitment numbers in UK.... and let Ichor make a complaint to FDA as really it is them a US company whos tech is being denied in the US.... especially if incoming data shows the combo to be effective (which I think it will)
It will certainly lead to a big reduction in the cost of the trial - especially as the pound is so weak against the dollar.
Well, we already have an idea of how results will go seeing as SCIB1 has already proven itself in the clinic... The value of US trial would have been huge though with KF and those top clinics involved but really data is data wherever it is gathered and could be US patients are going to be losing out on lifesaving treatments due to their own FDA....
'Professor Poulam Patel, Chief Investigator, commented:
"There remains an urgent need for improved therapies in melanoma. Based upon our previous successful trial with SCIB1 alone we are excited to see if the addition of SCIB1 to current, standard treatment with pembrolizumab increases our anti-cancer response rate."
I'm excited too.... though a little deflated at the saga behind getting here :)
least now we know what is happening!
Certainly sounds like an ultimatum was given and any stuck to. The rns says 'Operational activities for clinical centre initiation in the UK have now been completed' and a little further on 'Having considered the ethical issues related to patients awaiting enrolment into the UK sites' it sounds like things will be under way almost immediately, and to my optimistic self it sounds like they are very hopeful of good results.
Well, there are loads of pembro combo trials going on.. But Ichor is a US company so do not think it is anything biased against scancell being UK based... your right about patients though... no time to wait... good to hear Poulam is involved again too
So the SCIB 1 trial can now finally commence. I think the company has made the right move.
My reading is the FDA were taking too long to approve and the UK patients were dying while they waited for the FDA to make their minds up , so they effectively said to FDA, while you make your minds up we will carry on with the UK trial. Are any major US companies trying to launch their own trials in this area, I ask innocently?
Agree agree... But why is it the US IND has to be removed before UK can begin? does anyone know reasons for that?...... got a feeling the US trial will never happen... can't blame scancell for that but this whole SCIB1 combo has been a right dragged out mess of a trial ... At least it will now begin and scancell did act on the FDA being A holes
It would have been nice to have had that information earlier, but at least it would seem the logjam has now been removed and the trial can get going.
"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."
This was the information that CH missed out from his previous RNS. The UK arm of the trial starting was conditional on the FDA IND being approved.
Really glad that the UK trial can now go ahead but at the same time CH has gone down in my estimation.