Member Info for KonarA

Recently added? If so could some of these manufacturing details be key to approval?

Rhetorical question.. not expecting you to know the answer to that

Thanks for the recording. I was able to listen to it while mowing the lawn, so it can't be that bad a recording!

So does anyone want to admit to being the unnecessarily confrontational fud, carrying a 6 year grievance for RG not selling the company to a non existent buyer?

Lots of positives from these updates.. but the news that they cant open more sites in the UK until they agree to pay for the CI is particularly worrying. They have had over 4 years to plan this trial and they have repeatedly said UK sites were ready to go pending trial approval.

I've not been following the science of this, but I have a question for those that have, that relates back to patent discussion from a few weeks ago. Could avidimab be used to create a new improved potency of existing MAB treatments, resulting in a new patent protection? If so it could be very valuable to big pharma for protecting existing sales?

Aye, explains why patients are enrolled but not yet dosed.

Actual Study Start date: August 19th

"The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date."

Dont know if this has been posted before:

https://clinicaltrials.gov/ct2/show/NCT04079166?term=SCIB1&sfpd_s=08%2F27%2F2019&sfpd_d=14&sel_rss=new14

So looking increasingly like a NASDAQ float of BioNTech in advance of any commercial option on Moditope. Its a shame no one predicted this back in June - say perhaps around the 14th (5 days prior to BioNTech submitting their confidential filing) . Although i am sure if they had, that person would probably have been ridiculed as not knowing what they were talking about.. because after all, it would be inconceivable for BioNTech to float without Moditope.

That was my first thought.

I wouldn't read anything into it. Scancell retweeted the tweet where they had been tagged along with a whole bunch of other biotech. Reckon it was just fishing, and scancell accidentally re-tweet.. IMHO

i've emailed him a bunch of times.. yet don't seem to be on his list! Guess he is being selective.

@Inanaco - i agree they probably don't have to inform the market from a regulatory perspective. afaiac the RNS the other day announced the start of the trial.

but i note that on the 28th January 2011 they did post a "first patient dosed" RNS, and from PR perspective it would be another fail if they didn't this time round. imho

Seen a few values chucked about for when we may expect this to happen. Thought I would throw in my tuppence worth.

The RNS contained:

"Operational activities for clinical centre initiation in the UK have now been completed."
"Having considered the ethical issues related to patients awaiting enrolment into the UK sites"
"Patient enrolment into the UK arm of the study will commence immediately."

So the centres are ready, the patients are ready, and they are starting immediately. The whole argument of progressing with the UK arm of the study on ethical considerations for the patients waiting, only holds water if the patients are already identified. As such, I would have expected a "First Patient Dosed" RNS within days. imho

because starting a trial should not result in

"Not much change at all .................. ."

i don't believe they needed to mislead in an effort to keep their options open. They could have posted this, and still had the option down the line to withdraw the IND and progress the UK trial.

Instead we have had weeks of negative speculation as to the reason for the delay (which was only perceived as a delay by the false expectation setting), followed by a feeling of the board being "less than truthful". Both have which have unnecessarily eroded shareholder confidence.

Scancell are pleased to announce that they have received the UK regulatory approval necessary for the SCIB1 trial. UK dosing will commence once all international regulatory approvals are received. Scancell continue to assist Ichor in the collation of the data to support the FDA IND application, and remain optimistic that this will be resolved.

have AZ submitted an IND?

first thing i checked this morning was the RNS from april to see how it squared with the RNS this morning.

" is pleased to announce that it has received all of the UK regulatory, ethical and legal approvals required to initiate the Phase 2 clinical"

Notice how they say "UK approvals" and not "all approvals" required. Think it was "clever" wording to give the impression they could start whilst knowing full well they couldn't. I have no idea why the board chose to be this deceitful. The upshot being that (as usual) positive news (start of UK trial) is soured by negative.

whatever agreements CIC Capital had with Cindrigo it was very quickly terminated:

http://cindrigo.com/news-posts/contract-with-cic-terminated/

https://www.sedar.com/DisplayCompanyDocuments.do?lang=EN&issuerNo=00048115

Available here