Member Info for sadoldgit

One more post

After the initial implementation inspection, a test facility can expect to be inspected every 12 to 30 months. The UK GLPMA normally gives at least 10 working days’ notice.

There will be some circumstances when the inspection may be unannounced or at short notice. Monitoring inspections involve:

a review of the GLP quality systems
an inspection of facilities
an audit of completed and on-going studies
You must keep verified copies of any returned study reports and associated raw data for a minimum of 2 years or 1 inspection cycle.

At the end of the inspection the inspector will give you a verbal summary of the inspection findings and allow you the opportunity to correct any misunderstandings.

For-cause inspections
UK GLPMA carries out for-cause inspections if serious concerns are raised about a test facility, including:

allegations made by a whistleblower
possible fraud
serious non-compliance issues
Audits
Any regulatory authority in the UK or overseas can ask the GLPMA to audit a study that has been submitted to them.

The GLPMA checks that the study complies with the principles of GLP.

https://www.gov.uk/guidance/good-laboratory-practice-glp-for-safety-tests-on-chemicals#glp-monitoring-inspections

You are welcome crogy34.

One more lnk to go with regards to procedural compliance ( it is USA but will be similar here)
A bit of a minefield.
https://www.thefdagroup.com/blog/2015/07/gxp-audits/#:~:text=GLP%20Audits%20The%20main%20goal%20of%20GLP%20regulations,studies%20investigate%20certain%20test%20articles%20and%20testing%20materials.

Regards and keep the faith. Weather the storm out as they say.

Also interesting HbD.
The MHRA themselves may be facing a procedural audit. Government institutions can be a right bu99er to deal with at times. if it does not follow precisely what is written down it gets rejected.

interesting read in the link below

https://redica.com/pharma-top-10-pharma-inspection-findings-from-fda-mhra-and-the-russian-drug-regulator/

Crogy, No it is not good to go as such. i just put an extract up from a previous posters post.

These dreadful contretemps look to be pretty easy to resolve.

CRO has carried out all the preclinical work.
All their work should be in accordance with GLP.
They should have documentation of this, agreement that all work being undertaken will be in compliance with GLP
There should exist in a management control procedure held by the CRO detailing procedures to ensure compliance.
It may well be that all the MHRA require is a copy of this management control procedure (MCP) ( as long as it is in date prior to and during the period in which the studies are carried out)

MCP should serve as an overview. I cannot see what else the MHRA would require. If I were Tim i would have contacted the CRO by now ( he may already have done so). Effective communication in these matters are vital.

Top notch secretary worth her weight in gold. Even more so when dealing in government organisations.

Regards

HbD, forgot to put, good post. great contribution.

Regards

somewhere along the line there should be obtained by the sponsor confirmation from this CRO that the GLP will be adhered to. sareum most likely have it but should not be a problem as the CRO if they follow te correct GLP procedures will have a copy. May well be best to ask them for an overview of their GLP compliance.

The more you look into the more likely it appears to be such a minor yet important piece of supportive evidence that the MHRA require pre CTA approval

Regards

As Thoth used to put 'squeaky bum time'

I cant write Janus ****logy
I will try different Janus H0m0logy

Nice to put a positive title up as well. get rid of all the doom and gloom.

Regards

I would suggest your reasoning below on this is not far from the problem.

Wouls hazard a guess that Sareum would use a fairly close CRO.
We will know in due course.
An RNS to inform us that the issue has been identified and addressed would help settle the boat as opposed to what will seem an eternal wait for the final CTA decision.

Mountain and mole hill comes to mind.

Sareum are the worlds worst with communications.

Regards

The Company has now received the final signed report from the Contract Research Organisation that conducted these studies and, as previously reported, these data fully support the Company's plan to submit a CTA application in mid-2022 and to commence a Phase 1a clinical trial with SDC-1801 in H2 2022.

SDC-1801 is being developed as a potential new treatment for a range of autoimmune diseases and for the acute respiratory symptoms of Covid-19.

The report confirms that the studies met their objectives of identifying any organs or tissues that might be susceptible to high-dose toxicity and determining an appropriate dose range to test in first-in-human studies.

Sareum is working with specialist clinical trial consultants to design the first clinical trial with SDC-1801. This Phase 1a trial will investigate the safety of ascending doses of SDC-1801 in healthy subjects prior to the selection of an initial indication for further clinical study in patients in any subsequent trials. The Phase 1a trial will also investigate the effect of SDC-1801 on certain biomarkers of autoimmune disease that could be predictive of efficacy when tested in patients.

The safety of ascending doses can only be achieved in a clinical trial, irrespective of preclinical studies.

Also worthy of note is

' The Company has now received the final signed report from the Contract Research Organisation that conducted these studies'

I take it that this CRO carried out these pre clinical studies in compliance with GLP.

Regards

Perhaps the ethics committee meeting already taken place.

A lack of info detailing just exactly where we are at.

I believe they can apply for an extension Gunner68.

'If we raise grounds for non-acceptance you will have the opportunity to respond, usually within 14 days; however this may be extended on request.

Communication informing the applicant of the MHRA and ethics committee decision following receipt of the responses will usually be sent within 60 days of us receiving the original valid application. If an extension to the response date has been agreed this will impact the final decision timeline.

I think that we can conclude that from day1 there has been very little progress, as still require ethics committee meeting.

Regards

A member of the trolling brigade and their are more than one of the 007. I am not bothered and am more than happy to get into a constructive dialogue with any of them.
I am still waiting for a constructive engagement with rehgards to the questions I asked earlier. I have plenty more.

i am not a know all. But I have learned and researched.
There was a book written many years ago by a man called Dexter Jaeger titled Do not let anyone destroy your dreams.

At the very early stages of this share from am investment of just over 20 k i were 15k down i put basically everything I had into buying shares at 0.22 to 0.7p. Everytime it dropped you get the same dross come on board.
This share is going nowhere,
If it were that good why has no one bought it,
take your money and get out,
more money to be made outside of here.
this share going down to 0.2p

These negative people have an objective. Why else would you post?

I dont mind if people have bought on a low and sold on a high. But it does annoy when they change their tune in time with their buying and selling strategy.

Any way what were a couple of million shares that I had garnered and around another 50k i held around 9 million shares.

I have sold some and bought back. Some at a price I wished I had not. That were my decision, no one else to blame.

I sit fairly health at the moment. Not keen on the consolidation at all.

But i will continue to add at these levels, i most likely will sell some on a decent rise.

But I am not going to be put off in my game plan.

Regards

KAt perhaps if you understood what triggered the rise it may help.
2020 was all about Covid. Pharma companies increased as a whole. We had and still do a potential treatment for covid .
That is what bought the HNWI in and increase on an already rising share price.

PH have come aboard and have had 3 successes in binging this share down to the less than 2p old money per share.

Since the orchestrated war in Ukraine the AIM market cap has dropped from a high ov around 150billion to less than 90 billion. People come strapped for money.

As to why HNWI become invested? What you are inventing and testing in comparison to what competition there is at the moment and its future value.

We do not have a vast pipeline and we do not have a sustained form of income and that is what governs the SP at the moment. We also have an increasing expenditue.

If the science dont work then that is the end of Sareum. I will end up nigh broke as well. I will be here to at least when our first compound is licensed. How long will you be here for?

It is down to the science and has absolutely sweet FA to do with graphs. Sorry if I appear to rain on your parade. It is just my objectives are different than yours.

There are 66milion shares in circulation? Clearly very few of these have been sold since the poor RNS. Why would these people hang on to them? What does your graph tell you about the potential worth here.

Graphs are good at plotting data. Statsistical analysis is good. However try to look at the root cause of why things go up and down in value. The science does not change in its ability, only peoples perception of its worth. Still progresses with occasional setbacks as it was when i first invested here over 10 years ago.

Regards

Not know what others here opinions are but i would suggest that following successful CTA approval significant funding will be obtained. Leaning to the opinion of addition of funds by HNWI here'

Funds will we required for Ib
Funds for continued development of 1802.
Funds maybe for co development of 737.

Ball park figure of 6 million. 4 million for 1b and 2 million for translational preclinical in 1802.
On licence any time from end of 1a to end of 1b. Rationale behind this is once dose escalation studies are completed it will give strong indications as to what other immuno diseases 1801 has potential to treat.

in addition it will also give a good indication of the likelihood of good safety profile that will strongly enhance the value of 1802.

Until the dose escalation trial has been completed we cannot realistically put a value on 1801. With nothing proven at the moment and the delay with CTA approval there is not much we can do apart from wait.

Much potential with 737 despite the opinions that GSK know better than us.
GSK do not own SRA737 it remained the property of SO which i did point out several times months ago.
Sierra Oncology is a subsidiary of GSK and hence all legal obligations that were with SO still remain with SO

GSK obtained TESARO Dec2018
In addition to Zejula, TESARO has several oncology assets in its pipeline including antibodies directed against PD-1, TIM-3 and LAG-3 targets
i will add here
Zejula PARP inhibitor, ( niraparib) preclinical combo carried out with 737 circa 2019
The class of therapies have been plagued by safety setbacks, prompting their makers to limit their use in ovarian cancer patients, after clinical data suggested patients do not live as long as those given chemotherapy, in 'later-line settings', that is patients who initially have been treated with other drugs.
(I like the way they put 'prompting the makers to limit their use' The USA FDA would have instructed them to do that or have their FDA approval for Zejula revoked).

Jemperli PD-1 inhibitor ((dostarlimab),

The study evaluated the combination of Jemperli and chemotherapy against the combination of Merck’s MRK Keytruda (pembrolizumab) and chemotherapy in first-line patients with metastatic non-squamous NSCLC. Per GSK, the PERLA study was not designed to demonstrate the superiority of Jemperli over Keytruda in NSCLC indication.

( All that was done here was to achieve just enough to get approval where there is no alternative treatment at the moment. The foot in the door which GSK been doing for the past 25 years by fair means or foul)

Cobolimab T-cell immunoglobulin and mucin domain-containing protein 3 (TIM-3), Monoclonal antibodies which at one time was the latest in thing to have. They are not as good as were made out to be

This is GSK's line up obtained by the buyout of TESARO 1n 2018 for 5.1 billion.

All far from perfect. Available in the Uk for treatment.
Better more effective le

Goodmorning sneckieboy. Glad i got your attention.

Can you give us your opinions of the advantages of signalling Via the janus ****logy domain 2 over Janus ****logy domain 1. Is it better to signal vial both and if so what are the advantages and disadvantages?

Which domain does TYk 2 signal via and why do some state that their TYk 2 is allosteric whilst our 1801 and 1802 compound are described as non allosteric? Can you tell me the difference please.

Why would a pharma develop Tyk2 with Jak2 ? What are the advantages and disadvantages?

What are the main concerns regarging PARP inhibitors at the moment?

Why has BMS Deucravacitinib flunked in trials with ulcerative colitus? Why would SDC1801 prove to me effective in UC where BMS have failed.

A very easy one here for you. Why is it important to establish a high therapeutic dosage in the dose escalation studies if we are already planned to take psoriasis in a stage 1b trial?

You may be dissappointed in my answer, snekieboy but i am betting that your answer to the above questions to a somewhat moderate level of scientific understanding pertinent to the targeted application and potential on licensing of Sareum compounds will indicate your lack of comprehension, education but suggest a pure general ignorance.

Regards

Sneckieboy I am aware of the price. It is the ability of our compounds to out perform the competition. GSK paid 5;1 billion for their compounds. In my opinion not overly good compounds, well hyped up by paid technical authors. GSK market cap dropped over 4 billion.

Whilst we have a slight set back at the moment with CTA application at the end of the day what will make a decent market cap is an on license of just 1 of our compounds.
Sneckie boy and that Grocerlad not have much holding their ears apart. They have not been here long, have no idea of the calibre and development of CHK1 as were not here from early stages of development, in addition lack sufficient education or intelligence to take in the importance of science aspect. The most important aspect at the moment is to get phase 1 trial on track

Two fine examples of the latest generation of covid 19 stay at home share traders. Welcome aboard Beavis and Butthead, neither of you have contributed anything of substance which clearly exposes your immaturity and ignorance.

But I will post here Beavis and Butthead what I like when I like and how i like as i pay for a service and will make use of it.
if you not like it then i suggest you either filter me or pi55 off and play with your dollies, Dont feel down about it. Go and ask mummy for 99p so you can go out and buy yourself an ice cream.

Sneckieboy I am aware of the price. It is the ability of our compounds to out perform the competition. GSK paid 5;1 billion for their compounds. In my opinion not overly good compounds, well hyped up by paid technical authors. GSK market cap dropped over 4 billion.

Whilst we have a slight set back at the moment with CTA application at the end of the day what will make a decent market cap is an on license of just 1 of our compounds.
Sneckie boy and that Grocerlad not have much holding their ears apart. They have not been here long, have no idea of the calibre and development of CHK1 as were not here from early stages of development, in addition lack sufficient education or intelligence to take in the importance of science aspect. The most important aspect at the moment is to get phase 1 trial on track

Two fine examples of the latest generation of covid 19 stay at home share traders. Welcome aboard Beavis and Butthead, neither of you have contributed anything of substance which clearly exposes your immaturity and ignorance.

But I will post here Beavis and Butthead what I like when I like and how i like as i pay for a service and will make use of it.
if you not like it then i suggest you either filter me or pi55 off and play with your dollies, Dont feel down about it. Go and ask mummy for 99p so you can go out and buy yourself an ice cream.

It has knocked around 4 billion off of GSK market cap. Zejula is a PARP inhibitor. Ovarian cancer difficult to treat. Although early stages 737 ( albeit much research carried out post SO discontinuation) it has been postulated as potential treatment for HGSOC especially in combo. Hard to treat cancers like Ovarian and breast cancerdevelop resistance over time. The use of alternative pathway inhibitors in combination with 737 have been proposed as effective treatments.

Chk1 has not failed but Zejula is slowly failing. Desperation from GSK now as planning to use in combo with alternative therapies. Not looking overly bright for them. Do not be surprised if they restrict the use in Europe. Growing concerns on these type of inhibitors.

From Reuters

3 minute readNovember 11, 20221:42 PM GMTLast Updated 6 hours ago
GSK's oncology business suffers fresh blow with Zejula setback
By Natalie Grover and Pushkala Aripaka
Illustration shows GSK (GlaxoSmithKline) logo
GSK (GlaxoSmithKline) logo is seen in this illustration, August 10, 2022. REUTERS/Dado Ruvic/Illustration
Summary
Companies
News follows setback to GSK's blood cancer drug Blenrep
Shares fall nearly 5% in afternoon trading
Nov 11 (Reuters) - Britain's GSK (GSK.L) said on Friday it would limit the use of its ovarian cancer drug Zejula in the United States as a second treatment option to keep cancer at bay in patients whose tumours carry certain mutations.

The news marks a second setback for GSK's oncology portfolio this week, after the company on Monday revealed its blood cancer drug Blenrep failed to outperform an older therapy in a key study, calling into question Blenrep's existing U.S. approval.

Advertisement · Scroll to continue
The drugmaker's shares were down nearly 5% on Friday afternoon.

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Register for free to Reuters and know the full story

Zejula belongs to a family of drugs called PARP inhibitors - which include AstraZeneca (AZN.L) and Merck's (MRK.N) Lynparza and Clovis Oncology's (CLVS.O) Rubraca.

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The class of therapies have been plagued by safety setbacks, prompting their makers to limit their use in ovarian cancer patients, after clinical data suggested patients do not live as long as those given chemotherapy, in 'later-line settings', that is patients who initially have been treated with other drugs

Chk1 is still an extremely viable treatment in HGOC. Low to mid term toxicity (737). AZD for some reason high toxicity and its development discontinued.

Plenty of scope and indeed market here for CHK1 in combo for lung cancer ( proven high efficacy and good safety in preclinical) and with continued development

Template is simplistic
Always look easy.
It is so too easy to get something wrong. Especially something that you are inexperienced in.

Sareum have submitted what they believe was all correct. MHRA have to be vigilant. Over half of CTA applications require further info before CTA is granted.

Applications and processes are communications exercises. Sareum put in an RNS information they think we should know. The information in the RNS is open to too much interpretation. Now it is not only the MHRA who seeks further supporting evidence but also those who are currently invested here.

On the subject of investing there are over 66 million shares in issue. Are these investors (those that want to make money) on receipt of this 'won't approve CTA' news supposed to sell all their shares?

Sit tight and if it drops any more in the slightest then buy. That is what l will do.

Regards

If you did not feel some sort of jitters you would not be normal. Doubt and uncertainty are two of the most difficult problems to come to terms with.

The CTA requires further information/supporting evidence that is all.
However media Newswire state that Tim said that CTA won't approve CTA. That not good especially if you are the least bit pessimistic.

A very poor RNS released by Sareum. A bit panicky as of course they believe what they have submitted is all fine.

Scientists are not the best with regards organisational and communication skills.

If we're GSK more likely given as below

Slight delay expected as compelling data from potential best in class, revolutionary new compound in immunotherapy requested as part of the application process.

If this were given in the RNS most likely price go up.

Have a good day

Regards