Scancell Share Discussion Threads

[inanaco] 01/3/2019 17:53

I did post the question to scancell Bermuda ...

if you dont read the posts how can you reply ?

or is Clutter Lozan getting under your feet

[the real lozan] 01/3/2019 17:48

BoB - EXACTLY

[bermudashorts] 01/3/2019 17:44

Inanaco,


Without you posting fully your question and the answer it's impossible to comment. My understanding is that the IND has not been approved, that there are O/S requirements that are in the hands of Ichor and that once Ichor have satisfied the FDA Scancell will have to go back and ask for the IND to be approved.

On the funding side, they may have sufficient to commence the trial but they certainly don't have enough to complete it or start the Modi1 trial so funding will need to be sorted at some stage.

[inanaco] 01/3/2019 17:42

only as Franz Beckenbauer who was a formidable sweeper

even his wife gave him the broom ... clutter was not allowed

[the real lozan] 01/3/2019 17:37

YOU keep doing = GUFFAW
Maybe folks don't need to respond... because, unlike YOU, folks are ABLE to see, and GET the point. that FUNDING CANnot be dismissed as an ISSUE

[inanaco] 01/3/2019 17:28

Lozan ...

Clutter posting ..

I repeat again .. nobody is responding to you

[inanaco] 01/3/2019 17:27

No Bermuda

what i am saying is the drug side of the FDA has clearly been sorted as i asked Scancell are we in a "clinical hold"

and the reply came back NO ... we are held up by "medical device"

so you cannot say that the SCIB1 "drug" is in a "clinical hold" as an issue

scancell have stated its now FDA and Ichor ...

its out of there control ....

i did ask the very Specific question ..... "clinical hold"

so cut me a bit of slack here

if you cannot accept that ..maybe Cliff has it wrong ?

[the real lozan] 01/3/2019 17:21

Nappy, re my DIRECT question to YOU =
"Nappy, Just to CLARIFY ...19978 "Funding is not an issue"
'
Are YOU repeating YOUR last years FLAWED CLAIM of "FUNDING is NOT an ISSUE here"
OR
Are YOU dismissing / CLAIMING "Funding is not an issue" ... at, let's say - a couple of months / near future HERE ???"
.
Perhaps, due to YOUR difficulty in EVADING the issue/question, it would be beneficial for *US ALL* to presume YOUR dodgy 19978 "Funding IS not an ISSUE" is just ANOTHER example of YOUR misjudgement, leading to UNFOUNDED, FALSE CLAIMS made here.By YOU

[bermudashorts] 01/3/2019 17:19

Just to be clear, you are actually stating that the IND has been approved - you do realise that?

[bermudashorts] 01/3/2019 17:19

Inanaco - I have missed that. When/where did they say they're not in a clinical hold?

[inanaco] 01/3/2019 17:07

explain again

Scancell just stated we are NOT in a clinical Hold ...

[inanaco] 01/3/2019 17:06

BOOM ... scancell responded ... the 30 day has now passed

LOL

[the real lozan] 01/3/2019 17:00

Well,,,YOU CAN'T

[bermudashorts] 01/3/2019 16:59

The CBER DID ASK QUESTIONS!!!!!!!!

[inanaco] 01/3/2019 16:57

Lozan ...

stop cluttering up a good thread ...

nobody is interested in your funding posts ... nobody ever replies to them

[inanaco] 01/3/2019 16:56

so that refers to the actual question i asked Scancell

I am getting a bit confused with the Status of

The Combination trial and the FDA, are we in a state of "clinical hold" or are these questions asked by the FDA informal ?

I appreciate you have indicated that all the questions have been answered as per your proactive investor interview, but looking at the FDA procedural policy, 30 day turn rounds for a response is policy ... so I am not quite sure which rules are in play

reply was "medical devices" NOT "clinical hold"

[the real lozan] 01/3/2019 16:56

"Funding was not an issue lozan

.... funding has been raised "
....
SO = FUNDING WAS in FACT, an ISSUE...When YOU CLAIMED "It was NOT"
That same Funding YOU now CLAIM = " funding has been raised " 10 MONTHS AGO
.
Are YOU CLAIMING -
FUNDING WAS NOT an ISSUE here 10 MONTHS AGO
OR
Are YOU dismissing / CLAIMING "Funding is not an issue" ...in/ at, let's say - a couple of months / near future HERE ???
OR ...Both ???
Bearing in mind, YOU have been KNOWN to have been PROVEN WRONG in the past.

[inanaco] 01/3/2019 16:53

Bermuda

"have been compiled " past tense ...

time scales ...
which is why I looked at the 30 day ....

now i look at H1 2019

nothing has changed

Actually you don't have to ask for approval of the IND its automatic after 30 days if they don't respond ...

as it seems that is centered around the medical device then the IND is NOT on a clinical hold otherwise that section ie the "drug FDA" would also have asked questions


Review Time for initial submission of an Investigational New Drug application is 30 days from the date FDA receives the IND. An IND applicant may proceed with a clinical investigation once the applicant has been notified by FDA that the investigation may proceed or after 30 days if the IND is not placed on Clinical Hold.

[bermudashorts] 01/3/2019 16:43

Inanaco,

I'm sorry but I just don't accept that we've been told Scancell have submitted all O/S requirements. I can understand why you may think this as you're going by CH's comments on the proactive interview on 23rd Jan. I found the actual words used very difficult to hear and remember some debate about it at the time. Did he say answers to questions 'have been' compiled or 'are being' compiled? I just don't know.

Either way, it's sort of irrelevant because a week after that interview this is the situation according to an RNS:-

'Scancell and Ichor continue to work with the FDA to provide the additional information requested in response to the Investigational New Drug application submitted for the SCIB1 Phase 2 checkpoint inhibitor combination study'

You're right when you say that it's now between Ichor and the FDA and Scancell have no control over that but my point was that once that is sorted Scancell will then have to ask the FDA (CBER) to approve the IND. ie. They do have to go back to the FDA when Ichor have submitted all O/S requirements.

Regarding the last sentence of your 20045 - it hadn't even crossed my mind that the FDA would refuse, if you think that's what I'm getting at then you're very much mistaken. All I'm trying to do is understand the process to make some sense of the timescales here and manage expectations. Much better to try to understand why it may be taking so long IMO.

[inanaco] 01/3/2019 16:41

Funding was not an issue lozan

.... funding has been raised

[the real lozan] 01/3/2019 16:39

" "PHD" ... level staff are replying to questions asked ..."
.
Unlike YOU, who won't / CAN't reply to "questions asked ..as per =
Nappy, re my DIRECT question to YOU =
"Nappy, Just to CLARIFY ...19978 "Funding is not an issue"
'
Are YOU repeating YOUR last years FLAWED CLAIM of "FUNDING is NOT an ISSUE here"
OR
Are YOU dismissing / CLAIMING "Funding is not an issue" ... at, let's say - a couple of months / near future HERE ???"
.
*WE ALL* CAN clearly see and understand YOUR 'reluctance' to respond / Answer the question.
After all, Would anyone want to make a CLAIM... that subsequently was PROVEN to have been TOTALLY WRONG ???
Should FUNDING, in the 'not too distant', actually become 'an issue'... or a REALITY

[inanaco] 01/3/2019 16:23

ONE thing that i do know ONW

"PHD" ... level staff are replying to questions asked ...

Not TOSH/lozan/or ONW ...

[oldnotwise] 01/3/2019 16:19

Bermuda
Yep, a bit like saying we're planning for H1 2019!
I'm sure you realise where I'm coming from in all this, and it's not saying that the IND's really not likely to be granted (I hope)!
I guess the great issue here is that the FDA can keep on asking for more details (and I believe different panels can actually demand greater detail than others), so there's simply no benchmark from which to work. I may be wrong on this, so please give me a little leeway, I'm no expert. But that's part of the problem, noone here is, so we have to give and take a bit and judge for ourselves who (if anyone) has the monopoly of information.
It's not a straightforward situation, and there's certainly more to all of this than we (probably) really know.
In the meantime an update would be helpful, but what to say? "We've sent it all in and awaiting response whilst planning for a start to the trial in H1 2019"
Oh yes, that's what CH said today.... What else can he say???
Answers on a BB to .... Hehe
Anyway thanks for your input... really is appreciated.
AIMO
ATB

[inanaco] 01/3/2019 16:16

Boom

Scancell have already stated its now between Ichor and the FDA ...

and they have stated that "those questions from the FDA have been responded to" which included Ichor ...

listen to the proactive

anyway ..

no point discussing unicorns when you have no evidence that the FDA will refuse

[inanaco] 01/3/2019 16:12

No ... i don't need to re think ... ONW

as you have no evidence from the FDA to say that they will NOT approve

as such you cannot challenge any part of the post .. because Tri Grid 2 has already been approved in Europe ...

Scancell has stated all the answers to questions have been compiled and sent to the FDA

so your evidence to support failure is only based on conjecture created by yourself not fact