Scancell Share Discussion Threads

[panama7] 08/3/2019 09:54

Gazza, I hope you are right, the sooner someone buys this the better.

[oldnotwise] 08/3/2019 09:53

Gaz like the thought... Brightens the morning up whilst waiting for the garage to replace yet another sensor that's made me drive over here at a steady 50mph... Ain't technology great...
:-)
Wonder when the deal'll be rnsd hehe.
ATB

[gazza] 08/3/2019 09:38

Panama, yes another week of downward drift. I was thinking about this, take all the facts:

SP drifting to near all time low
Wall of silence from BOD - no reassurance re SP, nothing on IND or SCIB2.
5m Shares to move on
Funds WILL be needed quite soon.

Given all the above, why would the BOD be completely silent?
Why would the BOD apparently be unconcerned about the SP?

Perhaps - a sale is being negotiated.

Just a thought AIMO

[panama7] 08/3/2019 08:55

Another week passes still no IND resolution but according to Holloway the trial is on track to commence H1. No corresponding trade for the 5m shares sold on Monday doesn't augur very well for any when upcoming fundraise when no II has picked up the 5m for 6p. Maybe they think any fundraise will be considerably cheaper.

[tosh123] 07/3/2019 11:39

Thank you gentlemen, a very comprehensive response which is much appreciated.

[10acious] 07/3/2019 11:39

So that would appear to mean that Ichor will be a permanent partner for any and all products delivered via their device... ie you can't just buy the device after approval and go it alone!

[oldnotwise] 07/3/2019 11:37

Berm, Please, no worries, mine may be slightly shorter but yours has more meat!!!
Yes we are saying the same thing.
Thanks again for the expansion...
ATB

[bermudashorts] 07/3/2019 11:26

ONW - lol, sorry, was interrupted by phone call so took me ages to type above and your far more succinct 20408 wasn't there when I started. Think we're saying the same thing though:)

[bermudashorts] 07/3/2019 11:24

Tosh,

This is my understanding.

Ichor submit a master file to the FDA (from memory CDRH) division. The master file isn't an application for approval for the device in any way. That's done via a PMA 510k application and I assume the aim will be for Ichor to eventually submit a 510k application with supporting data from Scancell's and other clinical trials. The master file in this context is just a submission to the FDA which will provide them with the information and data needed to support IND applications from Ichor's customers. Ichor lodged their Master File back in Feb 2018. I don't think the file is reviewed at all by the FDA at this stage, it's simply held on record (could be wrong on this).

When an IND application is received by the FDA for a new drug trial that intends to use the Ichor device, it will include an authority for the FDA to access Ichor's master file. The FDA will then review the relevant sections of the master file but only for use for that particular IND. If, the FDA discovers that the master file doesn't contain sufficient info/data to support its use for that trial, it will request that the applicant (Scancell)rectify any deficiencies. Scancell then have to go back to Ichor who will make an amendment to the master file with the supplementary information.

It may be that Scancell's IND is the first the FDA have received for the new Ichor device, in which case any deficiencies in the master file might well also have applied to other IND's and so Scancell's IND might make for an easier journey for any future INDs.

Sorry this is so long winded and I must stress that this is just my own understanding and may well have got it slightly wrong but I think it's important to understand at least a bit about the process as it helps to explain why we are where we are!!

[oldnotwise] 07/3/2019 10:56

Tosh, I hope Bermuda doesn't mind if I join in. The trigrid V2 will ONLY ever be approved for use with a SPECIFIC BIOLOGIC.
Although the delivery system's being used in other trials it is authorised specifically as a delivery system for each trial.
It's not a generically authorised system which will automatically be approved in the future.
CH hasn't said anything different, as far as I can see.
AIMO
ATB

[panama7] 07/3/2019 10:28

Lozan, yes the Markets get it very well. The current share price is very much a reflection of the BOD's performance over a period of 6 years but is not reflected in their rewards.

[tosh123] 07/3/2019 10:28

Berm,
agreed.. but is it not by definition, giving the thumbs up to the delivery device as well as the SCIB 1 combination under the same approval ?
I thought that the approval of the device was just as important as the combo trial sanction ?
If im wrong i will stand corrected, i was just under the impression that both elements were being " approved " at the same time.
Would appreciate your guidance if i have got that wrong.

[the real lozan] 07/3/2019 10:19

Misguided Mantras -
" The S P doesn't matter"
" The market doesn't *GET IT* "
The REALITY is =
The 'market' is not a bunch of 'amateurs' with 'a dwindling financial, over-exposed position' looking for excuses
The 'market' is set / run by experienced Professionals,who KNOW what they are about
.
In Oct 2018 the S P was in the 10p s....some thought that was bad enough
Now the S P has sat in MID/LOW 6p s ...for almost a 'month' { having spent most of the time since Oct 2018 in MID/LOW er 8p s
.
NOT without 'reason'
The S P DOES matter
The 'market' DOES *GET what the 'market' Sees
The 'market' understands RISK / FUNDING / Time scales ETC.
.
Even if those with a 'less-than impartial interest' don't want to/want others to -
SEE what the 'experienced, Professionals' see
The S P is where it is for a REASON... Which is NOT 'cos folks 'Don't GET IT"

[bermudashorts] 07/3/2019 10:17

Tosh,

Just for clarity re. the IND, the FDA aren't looking at approval of the Trigrid device itself - it's only approval for use in the SCIB1 combination trial.

The very reason that Scancell are using the Trigrid device is the very reason why the FDA are going to make sure they are completely satisfied before allowing its use on humans and as you say they're not going to just take someone's word for it or nod it through because an old version of the device had no issues.

You have:-

A checkpoint inhibitor, which can in itself lead to hyperactive immune responses being combined with SCIB1 which generates a potent immune response and is delivered by a device which amplifies that immune response by 100 fold. It's powerful stuff and of course as the original SCIB1 trial wasn't run in the US it's the first time the FDA have looked at it.

Having said all that, wish they'd hurry up.

[tosh123] 07/3/2019 09:39

Re the FDA taking their time on signing off the trigid device.
Bearing in mind the fact that the US military are proposing to use the gun, coupled with the suing culture of the US in general, i can totally understand their requirement to be extra vigilant before giving it the thumbs up.
In principle, although the US military involvement can be seen as a very positive step, by definition, it also increases the liability on the FDA to ensure that they do their job correctly.
Just taking someone else's word for it, is not in their remit, nor would it be the professional thing to do, because in the very unlikely event that something went wrong, that would open them up to massive criticism, and quite rightly so.
Just let them do their job.

[floydymagic] 07/3/2019 08:58

SKIN Integumen


Wonderful growth stock about to take off.

[oldnotwise] 07/3/2019 08:56

Tosh
Probably nothing to say ... ;-)
ATB

[tosh123] 07/3/2019 08:49

ONW,
at least its remaining above the 5p threshold, which is a positive.
If it breaks into the 5's, it could be a real issue.

Looking at the LSE BB, it looks like a one man show over there now ... out of the last 25 posts, 19 of them have been penned by the same poster ( C7 ).
Now i wonder why no one wants to post over there ???

[bermudashorts] 06/3/2019 18:47

super - yes exactly

re. Woodford - yep things not going as smoothly as he'd hoped it would seem!

[supernumerary] 06/3/2019 18:06

BS - to meet new withdrawals!

Incidentally I saw that Woodford had come in for some criticism over the weekend. It seems that his Income fund, which was sold as a stable FTSE 100 big business income-reaping fund (why not buy a tracker, we ask?) has been forced by withdrawals to sell off many of the large cap stocks to meet the redemptions, leaving it looking more like a high risk long term small cap fund :) So now, apparently, he's shuffling stocks around his various funds to make it all look right again...

[inanaco] 06/3/2019 17:31

Tosh

what price did you buy shares at all those years ago ...

as since you have not traded apart from the known top up around 27p of £1000 that was after ONW sell ..

[oldnotwise] 06/3/2019 17:15

Tosh, actually, no.I started out thinking "when" but I've recently begun to perceive a drift towards IF, so that's why I'm saying that the spell is beginning to be eroded from the outside.
Hence the reason (quite apart from cashburn) that the deal (IE the Rabbit) needs to be produced sooner rather than later!
AIMO
ATB

[bermudashorts] 06/3/2019 17:13

Super,

re. City Financial, yes you're absolutely right but it does temporarily relieve them from the position of being forced to sell to meet withdrawals.

[tosh123] 06/3/2019 17:02

ONW,
we both know its always been "if" rather than "when", hence the race to mitigate the risk by trading in and out until a comfortable Risk vs Reward ratio has been achieved.

Like yourself, i do still hold out hope that the bunny will appear though, and if we're still in business by 2021, then its my opinion that we could well see some positive share price movements.

[tosh123] 06/3/2019 16:55

Super,
good to hear from you...
Unfortunately the BB has been infested recently, but i hope that the last liberal application of Canesten Cream has had its desired affect.

Hopefully "City Financial" will survive, but alas im not very confident of that. The city will turn on any weak animal and tear it apart at the drop of a hat.

Lets see how the situation plays out though.