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You were being asked (very nicely) by a relatively infrequent poster to speculate on this issue as he/she clearly values your opinion and needed help understanding.

Alternative to what? I haven't read any theories on the bb although I might have missed them as haven't been keeping up very well lately. As far as I can see, we haven't had any explanation from the Company and very little discussion on the bb.

Icalvert,

As far as I'm aware, all we know is that there will be a safety run in with 6 patients, it's not clear whether they'll go straight in at the 8mg dose or do a cohort of 3 patients at 4mg and then escalate to 8mg for a second cohort of 3 patients. I very much hope that they're going straight in at the higher dose as it will impact on length of the overall trial. As they haven't mentioned dose escalation in any presentations I expect that's the case.

Inanaco,

Re. your 11.53, why not speculate on the reason? In the absence of further details from the BOD, I can't see why it shouldn't be discussed on the bb. Look back over the posts this morning, mostly speculating about one thing or another - isn't that what bb's are for?

Ivy made it very clear in his post that he wasn't expecting the BOD to give away or discuss price sensitive information and I have no idea on what grounds you make the accusation in your 16.23

It's not at all unreasonable given the circumstances for shareholders to ask questions at the AGM and to expect the BOD to answer as fully as possible. If they can't due to disclosure regs. then they should be more than capable of dealing with that.

The reason I'm asking about the loading of SCIB1 to the Ichor device is in relation to the IND.

I thought I had read somewhere that one of the improvements with the new device is the ability to supply cartridges with the vaccine pre-loaded and if that's the case then the manufacture and supply of those cartridges would form a major part of the IND application. I could have completely imagined this though which is why I was trying to find out how it worked with the mark 1 version!

If the information isn't price sensitive then why isn't it fair? If you take your argument to the extreme then the BOD would never be able to answer any question from any shareholder. For instance, Lindy wouldn't have been able to answer any of your emails as that wouldn't be fair. No, if individual shareholders want/need to know more about the Company, its products, strategy, finances or whatever, there is nothing wrong with asking or being given answers as long as it doesn't break disclosure rules.

I haven't shot down Ivy's posts because I genuinely don't see what's wrong with them and I'm surprised you think Ivy is naive enough to expect answers to price sensitive questions. Even if he did, the BOD should be more than capable of dealing with that.

.........but the mark 1 device doesn't does it? Thought cassette comes ready to just insert syringe of vaccine by the nurse/doctor. Know somewhere there was a video, think from Southampton showing a lady being treated but can't find it now.

Right, thanks. Glad I asked and that you have explained - wondered what you were getting at.

There are plenty of questions that the BOD can be asked and that they can answer that don't involve price sensitive information For example, there is nothing price sensitive about revealing a bit more about the issue with the FDA - I'm absolutely sure greater understanding would help shareholders. eg. More about the issue, is it manufacturing, safety, or just lack of supporting data in a certain area. Do they have to do some additional preclinical studies? Is that in Scancell or Ichor's court or both? Hopefully that will all come out at the AGM.

By the way, do you know whether the new device involves loading of the vaccine by the physician at the point of treatment or will the cassette come pre-loaded with SCIB1 and all ready to administer?

What has Tommy Robinson got to do with this?

Wigwammer, not sure it makes a huge difference to the funding requirement. As I understand it, the trial design hasn't changed, they will simply open an/some additional study centre (s) in the UK. So the trial will still be the same with the same protocol and the same no. of patients.

Just wanted also to add a comment about the suggestion of pressing ahead with the trial in the UK. Although the new device is being used in Europe and therefore has been cleared by the EMA, that doesn't mean that Scancell would automatically receive CTA approval for the SCIB1 trial. It may be that whatever issue the FDA have would also apply to the MHRA and European regulators. ie. the issue isn't with the device itself but in connection with its use in the SCIB1 trial.

re. your 11.11 - that quote was from Rob Bernard, CEO of Ichor so use of the word 'ours' is correct.

All we have been told is that the issue is related to the use of the Trigrid device in the SCIB1 trial. That's a completely different scenario to the FDA having a problem with the device itself. The former suggests that the FDA require more data in relation to administering SCIB1 with the new device in the combination setting. The latter suggests a much more fundamental problem with the device itself and that the FDA have not yet cleared the device for use in trials.

Scancell would not have signed a licensing agreement or submitted their own IND unless they were satisfied that the FDA would allow its use in clinical trials ie. they had cleared the master file. The timescales announced mean that this isn't just a question of answering a couple of queries but more likely the FDA have asked for some additional testing data - either related to the use of the new device with SCIB1 or the use of electroporation and SCIB1 in the combination setting. That's just pure speculation on my part though.

Whichever scenario is correct, it would be good to get further clarification and explanation from Scancell.

sorry, meant to add that I agree with your point that those trades are likely to be retail investors rather than institutional.

'Don't forget most large shareholders have a seat on the board'

Unfortunately not so, in fact shareholder representation sadly lacking on the BOD. KCB's resignation has left a gap that needs to be filled and very much hope they'll redress the imbalance asap.

I hope/expect that Scancell will give a better explanation and more details on exactly what the FDA are asking for - is it further preclinical studies? If so who is responsible, Scancell or Ichor and what are the timescales? Is it in relation purely to the Trigrid device in general or specific to the SCIB1 trial protocol?

How did you search the FDA site? What section did you search? I didn't think the FDA ever made public details of IND's or master files for devices that had been submitted or cleared.

Yes I know they're unique.

Yes exactly - the GSK cancer vaccine fails were hugely damaging to the whole field of cancer vaccines back in 2011/12. It doesn't matter what the antigen was or the intricacies of the tech. - after those fails, nobody would touch cancer vaccines and the road Scancell had to travel with SCIB1 was much, much harder as a result. If those GSK trials had been a slam dunk success then it would have been a different story.

The very best news we could have are fantastic success stories for TCR therapies from other developers. Hopefully Adaptimmune's trials will produce better results at the next dosing level.

Re. your 21.11 to Ivy, do you think the issue with the FDA is linked purely to the Trigrid device then? ie. It's not the the device with the SCIB1 trial protocol?

Crumbs,

Not sure we can take any comfort in the situation with Adaptimmune. If Scancell are pinning hopes on collaborations with BioNTech and Karolinska for Modi TCRs then the last thing they need are disappointing results from any other operators in the field. Much better that Adaptimmune had produced stunning results which would then translate to investor interest in the sector and potentially higher valuation on any deals.

A very poor day all round.