Member Info for sadoldgit

Welcome aboard Paul Hogan.
What a fantastic coincidence that you recently invested before Christmas. Before any announcement made by Sareum of intention to start trials down under.

Paul Hogan is an Australian comedian. How on earth from the other side of the planet did you manage to find out about this little gem? Did you view the AGM by Sareum of the 16th Dec 22?
I would wholeheartedly suggest you look through RNS history and do a little research and then perhaps you may well understand what you have got yourself invested in. What did you conclude was a fair price after your ;good news was in the air' report? Did you ask your friend what this good news might be?

Regards

Nicely, Ahfams posts are good.
Nothing wrong with a positive attitude and confidence. At least his posts are constructive.

One or two of the 'thought Police' about.
Disappointed, I were reckoning on attracting more than that.

Belhouse may I suggest that sorting the backlog out will take a considerable amount of time. Firstly they will need to implement a plan to reduce backlog.
Should approval be given in the next couple of weeks the I would be of the opinion that starting the trial here would go ahead. I do not believe there exists the remotest probability of that. Much later down the line, yes. And yes that will provide Sareum with options.

Inexperienced staff and shortage of staff are reasons given for delays. There is very little can be done to magic a way out of this one with any degree of speed. New applications that come in? Do they handle these first or do they clear the backlog?
I very much doubt they will be able to reduce the increasing rate of backlog, let alone reduce back to timescales, in compliance with statutory stated timelines by the end of 2023..

Looking at the Oz clinical application procedures, by comparison far more streamlined with shorter approval times.

No data or indications of any problems with backlogs, delays or complaints can I find.

HREC review 1 to 3 months. Time dependant on institution involved. HREC cover preclinical trial data too.
14 weeks will take us to the period of reckoning in Oz. End of June at latest, beginning of May the earliest. Sareum will now have expected timeframes to anticipated approval that they can now work to. Nothing worse than not knowing how long you need wait for, or what the outcome will be.

Not a 100% guarantee of success as nothing ever is. But personally I feel way more confident.

I am sure Tim and co have worked diligently on this one as they are irrespective of what some may say, committed to getting 1801 into trials.

Regards

Xiolet how have I gone on about Jewish people?
Can you explain how by posting about the wealth and control of the wealthiest of people put everything else I have said in a bad light?

Was you rude? Was that your intention? was that your 'kinda' thinking?
It either is or is not, not 'kinda'.

Potnak, good afternoon. There was a documentary on some years ago. You could take David Cameron out to dinner at a cost of 150 to 200k. The crux of the matter is effectively to procure lucrative government contracts.

By those at the top, and meaning those that influence and control our governments the working human is seen as just another animal to be farmed. In this case for money wealth and to maximise control by those at the top. That my very strong opinion.

Cost of living for some is getting difficult and yet to control inflation and curb spending they raise interest rates. Where is the logic in that?

The only logic is, the amount of debt you have the more control they have over you. Banks will never lose out. Rothschilds are estimated to control/own around 15 trillion dollars in the banks that they own.

It has been stated by some that this particular group of extremely powerful people have their own army. Referred to as NATO.

A one world government that ensure the rich get richer and the poor get poorer. Of course much corruption goes on.

Regards

Patents.
Maybe of interest to some and slightly off topic.
Looking through patent description pertaining to SDC1802

EXAMPLE 8

Tumour Growth Delay Study in Male SCID Mice Bearing CCRF-HSB-2 Tumours

[0133] A total of 40 male SCID mice aged 5-7 weeks were used for the study. These were purchased from Charles River and allowed to acclimatize for 7 days prior to tumour implantation. Animals were housed in IVC cages (up to 5 per cage) with individual mice identified by tail mark. All animals were allowed free access to a standard certified commercial diet and sanitised water during the study. The holding room was maintained under standard conditions: 20-24°C, 40-70% humidity and a 12h light/dark cycle.

Now it does state purchased from, which in does not infer the work was undertaken by.

But lust look at changes to this CRO and who it is owned by now.

Purchased from Charles River

We go to Charles River ( US founded)
In October 2003, Charles River Laboratories merged with Inveresk, a research company based in the United Kingdom. The company was known then as Charles River Laboratories. Inveresk specialised in clinical research and pre-clinical testing, and their main facilities are in Edinburgh, Scotland.[10] In late 2009, Charles River sold its Clinical Services Division in Edinburgh to Quotient Bioresearch.[

BEIJING, February 4, 2016 – Pharmaron, a fully integrated contract research organization (CRO) offering laboratory and manufacturing services for pharmaceutical and biotech research and development, today announced that it acquired Quotient Bioresearch (Quotient). Quotient, a UK-based CRO with more than 200 employees, focuses on integrating radiochemistry and metabolism. Part of this expertise is derived from Quotient’s previous acquisition of GE Amersham’s radiosynthesis business.

Mainstay now looks to be Cardiff.

Our experienced team of synthetic chemists, analytical chemists and drug metabolism scientists synthesize and use 14C and 3H radiolabelled compounds to study the absorption, distribution, metabolism, excretion (ADME) and fate of a wide variety of compounds in clinical, preclinical and discovery investigations. We offer unrivaled expertise in conducting metabolism and pharmacokinetic studies using radioisotopes.

Regards

It Deucravacitinib pure Tyk2?

Clearly it is not pure TYk2 the very nature of having selectivity over Jak1 2 and 3. However

Deucravacitinib (BMS-986165) is a potent, highly selective, allosteric, small-molecule inhibitor of TYK2 that acts through a novel mode of binding to the JH2 pseudokinase domain, which locks the kinase in an inactive state.

This binding site is more diverse among Janus kinases (JAKs) compared to the ATP binding pocket of the active site where the approved JAK inhibitors (JAKi) bind, which is highly conserved.14, 15 Thus, JAKi are ATP competitive active site inhibitors with pharmacologic activities against JAK1, JAK2, and JAK3 in differing proportions depending upon the drug.16

Notably, to date, all JAKi have some activity against JAK2, which carries specific liabilities.17 Deucravacitinib has 200-fold greater selectivity for TYK2 inhibition over JAK1/JAK3 inhibition, and 3000-fold greater selectivity for TYK2 inhibition over JAK2 inhibition in cell-based assays.18, 19 A more recent analysis of the selectivity profile of deucravacitinib also demonstrated highly selective inhibition of TYK2 and not JAK 1/2/3.19 Although TYK2 is a JAK family member, TYK2 is only involved in specific immune-regulating cytokines. In patients with psoriasis treated with nonselective JAKi, typical laboratory changes are observed, including decreased hemoglobin levels, decreased lymphocyte or neutrophil counts, and increases in cholesterol levels and liver transaminases.20-22 These changes were not observed in patients with psoriasis or psoriatic arthritis treated with deucravacitinib, and demonstrate that the in vitro selectivity profile is borne out in the clinical profile.23, 24 The efficacy observed in psoriasis is evidence of effective inhibition of IL-23 and the downstream Th17 pathway.

We can conclude that Deucravacitinib contains albeit is selective over Jak 1,2 &3.
However the claim that it only acts allosterically is based upon observing no typical laboratory changes associated with non selective Jak1.

Typical therapeutic dosing for Psoriasis is 12mg body dose.

Dose range for SDC1801 is in the range of 12.5 mg to 1000mg maximum although we have established no MTD

Comparison between dosing schedule between SDC1801 and Deucravacitinib is phenomenal to say the least.

Regards

Krone. Thanks for that little gem of info.

Our submarines are some of the finest if not the finest subs. If it were not for that they would be looking elsewhere.

'Several ' with regards to 737. that by definition is a minimum of 3

Once the application is processed and approved, the ASIC will issue an Australian Registered Body Number (ARBN) which is a unique, nine-digit code. This is similar to an ACN (Australian Company Number), but specifically to registered foreign companies.

ASIC can take up to 28 days to process an application to register a foreign company.

To set up a legal entity ie register a company takes around 28 days in Oz

My take on this Mafuta is at the AGM it were stated we were looking at companies in the Europe and one outside of Europe. An odd ball here is stating translation of data. I would hazard a guess that this may have been Japan. However, what we can say is Sareum since the AGM have not sat idle. They have done their homework on this one.

More of a formality for approval by the usage of phrases that differ from when CTA was made to the MHRA I believe.

As I understand the MHRS have requested a review by the GLPMA. It is only the MHRA that can request this review. However, according to this meeting the MHRA have not requested a review.
Is it any wonder Sareum have initiated the steps to carry out clinical trial in Oz.

CPF in control of negotiations with regards to 737. That we knew anyway.
It had taken SO almost 2 months to return all appropriate data.

It is evident that considerable communications have taken place regarding progression and encountered difficulties with MHRA between Sareum and Australian regulatory bodies prior to initiation for CTN.

Regards

Overview of process in Oz

https://credevo.com/articles/2018/03/30/how-to-get-started-with-your-clinical-trials-in-australia-regulatory-and-site-perspectives/

Clearly much preparation has been undertaken by Sareum BoD

The sponsor of a trial can be an individual, company, institution, or organisation which takes responsibility for the initiation, management, and/or financing of a clinical trial.

The type of sponsor will vary from trial to trial, depending on who takes overall responsibility for the conduct of the trial. If the investigator initiates and organises the trial, he or she is defined as the sponsor of the trial and will be responsible for the sponsor's functions.

The sponsor of the trial must be a legal Australian entity. An overseas company, person or entity, for the purpose of the Australian legislation, is not the 'sponsor' of the trial in Australia.

The Australian clinical trial sponsor is responsible for submitting the CTN or CTA.

The overall decision as to whether a CTN or CTA is required in relation to the
use of the therapeutic goods is the responsibility of the trial sponsor.
Consultation with the HREC that will approve the trial protocol may assist in
the decision

https://www.tga.gov.au/sites/default/files/australian-clinical-trial-handbook.pdf

For the route to be chosen I believe that Sareum have already been in consultation with HREC.

I don't think the UK CTA will be going anywhere soon.
There will be a back log for one and secondly it does not appear anyone is keen on addressing the issue.

We over complicate things in this country. In an effort to portray high standards a lot of applications and referrals get kicked into touch. They dont get addressed and they dont get resolved.

I have not missed your point there J4F.
I did notice the subtle change in wording myself. I would suggest that communications have taken place between Sareum and Australian Clinical trial applications. CTN is Clinical trial notification as opposed to application.
My interpretation for what it is worth is the notification is a formality followed by a review by the ethics committee. Decisions being made here at local level. I am am not saying this guarantees approval but it will be nowhere as difficult or as complex as the MHRAand GLPMA fiasco which has been identified as not only being understaffed but also a high degree of inexperienced staff.
Individuals that should know in an ar5e covering exercise pass the buck so as to speak. Wrong people in the wrong jobs.