Scancell Share Discussion Threads

[tosh123] 01/3/2019 13:44

ONW,
he's always WRONG, and then , as you say, spends post after post trying to wriggle out of his ludicrous statements by attempting to steer the conversation off topic ... its like a spoilt child... Pathetic.

Zero respect for the idiot...

[tosh123] 01/3/2019 13:18

Loz / ONW,
just another " he got it completely wrong " moment to add to the ever increasing list.
No one should be surprised that he got it wrong though, after all he's been 100% consistent with that over the last 7 years.

[inanaco] 01/3/2019 13:14

Can always remember Building control refusing to pass off £1m of buildings because the plans "approved" did not have a concrete ramp for wheelchairs ..so we had to cast the ramps to a door that was to narrow for a wheelchair

ONW "Working for the protection of Ramps"

[inanaco] 01/3/2019 13:05

Actual text ONW

The rate limiting step to answering all the questions received from the FDA relate to the Ichor Trigrid 2.0 device. Ichor is in dialogue with the FDA regarding responses to those questions, and this process is completely independent as it relates to the FDA’s device division. I appreciate this is a very frustrating situation but it is unfortunately out of our control.

That said, we are still planning on initiating the study in this first half.


so as far as i am concerned ONW it's only you "pontificating" again

[inanaco] 01/3/2019 13:04

Having spent my entire life dealing with Regulations and bureaucrats .... i know how pedantic they can be ..

Scancell has simplified it ...

they do not see an issue and expect the trial to start h1 ..

the only party that blows it up out of all proportion is you .. based on NO evidence at all

ATB

[oldnotwise] 01/3/2019 12:53

I could agree with the simplistic view you take. I could do that and say it's inevitable.
But if that's the case as you state, why then did the FDA require further information since according to you it's only a rubber stamp job, and if that were the case why has it overrun the expected timescale, and why were further details required by them in the first place?
I think you tend to oversimplify some issues and IMO this is one of them.
I certainly hope to see an outcome that we all wish for, but please don't pretend you have all the answers.... You don't!
AIMO
ATB

[inanaco] 01/3/2019 12:47

ONW ...

sorry ONW ... not sure what the biological difference between a DNA vaccine and a DNA vaccine is ... do you ?

only the gun is designed to open cells for the DNA to enter ...

Basically you are trying to BIG up an ISSUE

maybe you can explain the Biological part ? as that would then fall into the Clinical Drug side of the FDA

not the device side

[oldnotwise] 01/3/2019 12:37

Inanaco
It is NOT inevitable.
The questions raised are specific to the combination of the Trigrid V2 and the Biologic Agent being delivered.
If it were inevitable there wouldn't be any delay because there would be no questions to ask.
Sadly (or maybe not) the FDA have the whip hand here since they're the licensing authority, not Inanaco.
The FDA could conceivably keep this tied up for many months if not years should they choose to do so!
AIMO
ATB

[inanaco] 01/3/2019 12:28

As the Tri Grid device is already in trial in Europe, i have no issues that it will not be approved Lozan

the word is "inevitable"

"Pretty sure" was not a claim

as such the drawing Board is not required ...

[the real lozan] 01/3/2019 12:23

So, the 'CLAIM' -
"Pretty sure that we will have the SCIB1 combo FDA rns by the 12th march "
Now AGAIN, seems AGAIN, to have been UNFOUNDED ???
Oh well ... back to the 'drawing board'
.
However, This time YOU seem prepared to ALMOST admit = YOU got something WRONG
AGAIN

[inanaco] 01/3/2019 12:02

Bermuda Got the answer about the 30 day issue

FDA regarding responses to those questions, and this process is completely independent as it relates to the

"FDA’s device division"

thus the protocol does not apply

[the real lozan] 01/3/2019 11:45

"everything is on track and going to plan." -
Which 'PLAN' is that exactly ???
The 1st PLAN, the 2nd { a repeat of the 1st}, the 3rd { a repeat of 1 and 2}
Is there a 4th Plan { FUNDING} looming ???
trHYPERS would/ will dismiss the thought.
Sureleee, the time has come for ANY PLAN to be put into opperation - So WHY isn't it ???
The ONLY PLAN that has been put into opperation here...IS inane'n'co's PLAN, which is =
To turn a 'silk purse' into a Sow's ear' then try to 'Flog it' for £8+
{ There are STILL some who believe £8+ for a 'Sow's ear' ...is a bargain
Whilst the WISER, more ASTUTE CAN pick one up for UNDER 7.5p }

[panama7] 01/3/2019 09:47

Bermuda, you state that it's quite easy for these things to drag on, but this is now 3 years of dragging on , 3 fundraises to pay for a trial that has still not started and still not in a position to start and throughout those 3 years we are told at various points that everything is on track and going to plan. This BOD are incompetent beyond belief.

[bermudashorts] 01/3/2019 08:27

OT'ish but not sure whether any of you watched the first part of the BBC2 documentary on the Parkinson's drug trial last night - if not, it honestly is worth catching up on iplayer before the second part next week. A real insight into the complexities and realities of clinical trials, especially randomised trials.

[oldnotwise] 01/3/2019 08:08

Bermuda,
Well said !!

[bermudashorts] 01/3/2019 08:03

gooosed/ONW/panama - yep am sure none of us thought we'd be sitting here in March still waiting for news, especially after Sally Adam's AGM presentation which suggested the questions for Scancell were mainly around CMC and were very easy to deal with and that the majority of work for Ichor was just a question of providing documentation.

Having said all of that, it's quite possible, even likely that the responses would have generated further questions from the FDA and of course the US Government shutdown must have impacted on turnaround times at the FDA. So I can see how it's quite easy for these things to drag on. Even so, it is frustrating and more so when it took Scancell so long to submit the IND in the first place.

If there's to be much more of a delay, I hope Scancell will find a way to update the market on the latest state of play, not just for the IND but also appointment of the CRO and where they're at with MHRA approval.

[oldnotwise] 28/2/2019 21:07

Interesting comment by Goosed regarding the IND issue.
I find it surprising that we've not had the response we've been expecting, and as I tried to say earlier today I'm hoping it's no more than a glitch. However I also wonder about one of our IIs reducing their holding, and given the massive enthusiasm that the "New" investors created when it was found they'd taken some of our fundraiser, does the Corollary apply?
The share price seems to be supported (in an environment of miniscule volume) at the 7p level, but it ddoesn't have a robust feel to it.
I agree with Bermuda's earlier comments regarding the need for News so I hope we can get the start of a positive flow, but I'm concerned that one swallow doesn't make a summer... I think a flight would serve us well.... Gulp!
Let's hope the imminent arrival of summer will clear away the gloom. :-)
AIMO
ATB

[gooosed] 28/2/2019 19:22

Bermudashorts - thanks for your reply. Informative & comprehensive as ever.

The ongoing IND fiasco should (imho - going by assertions made at AGM by SA) have been resolved by now but perhaps for Trumps tantrum - who knows. News of possible developments around SCIB2 delivery mechanism (hopefully updated by CRUK around April) will be eagerly awaited but the current Scancell CEO/BoD do seem somewhat aloof in citing selective disclosure for declining to update.

[panama7] 28/2/2019 18:42

Bermuda, you could well suggest it will start in 2020 and be very accurate, let's face it we can't actually believe anything the BOD tell us about timescales.

[bermudashorts] 28/2/2019 18:32

Panama - no not suggesting for one second that it will, just answering the question which was when is the latest the trial could start.

[panama7] 28/2/2019 18:14

Bermuda, it won't go beyond 2020 to start dosing as we've been told everything is on track and everything is going to plan and the trial will start H1 this year.

[bermudashorts] 28/2/2019 17:07

goosed - good question.

DNA vaccines are known to be stable and have a long shelf life. As you say, the new batch was completed in August 2017 and from memory, I think the original batch took about 6 years to become obsolete. That suggests that the forthcoming trial must be completed by around 2023 and on the basis that it's likely to last approx. 18 months, they would need to start dosing by 2021.

However, it's not quite as straightforward as that. I'm sure the FDA will want to ensure that the drug supply is adequate to complete the trial in good time before there is any danger of interruption in supply. I don't think they'd allow them to cut it fine and just hope the vaccine stays within specification long enough complete dosing, especially given previous issues. On the other hand manufacturing techniques and stability of the vaccine may have improved since the last batch was manufactured so it's really difficult to say.

Probably worth asking Scancell directly but my best guess is that they have a bit of a cushion at the moment but wouldn't want to see it go beyond 2020 to start dosing.