Member Info for sadoldgit

I will take on board what you have posted.

Regards

Fanti if we receive a rejection that really would smash the SP. Only thing I would consider is the application via another country. This may be in progress and if so, would have expected an RNS to indicate this approach. As stated by Tim and co at the AGM they are committed to getting SDC1801 into clinical studies. This is all we can really go on. They know more than us and always will do.

Regards

The CTA approval is critical for Sar development and worth. Of that there is no question.

There are no timeframes I can find pertaining to GLPMA review.

Those that disagree with my narrative are welcome to filter me.

You post
' I'm not being negative but this isn't all down to backlogs. The 'non approve' came back on time so they looked at and reviewed the application on time. There is more to this than we know and we cant pretend otherwise'

What factual info is contained here?

'Someone said in the Telegram group the the only posters that have been consistently correct have been the so called ****wombles and its true'

If I took notice of what someone said in the Telegram group and made decisions on what so called ....wombles said I would have no shares left.

CTA approval will take time my estimate 6 to 12 weeks. From beginning of year.
737 likewise minimum of 6 weeks from 12th Jan. Tim himself stated it could take 1 day to a month to sort out patient generic data. This is after the return of all data ( a couple, then a few weeks).
Data after analysis will then lead to a discussions on a way forward.
Interested parties then go to informal and if very interested to formal communications.
This in itself will take time and as I did suggest before I would expect significant news around Easter time.
Continue investigations in combo as were being designed by SO. Commence trials and then on licence or maybe just on license, these were the outcomes stated by Tim at the AGM.
Tim also stated that would be looking at combo. That would include 737 and LDG.

Why not as the Chinese with their CHK1 inhibitor and Acrivon with their on licence of Prexasertib, are going the same route and have application for stage 2 trials ( Acrivon).

Acrivon has little to no patent protection and was licensed for an upfront fee of 5 million dollars with no payments or time frames disclosed on their agreement that i found access to.

When we will receive info on developments is rather like asking how long is a piece of string.

It is not a case of if it is a case of when. The 'when' being the fly in the ointment.

However, please feel free to filter me if you are of the same opinion as what an individual expresses in the Telegram group.

Regards

Unable to approve.
CTA submitted end of July. Notification seeking further information 8th November ( over 100 days) is not on time.
The aim of the MHRA is to give an initial assessment within 30 days.

How do you claim to make such an absurd claim that the 'not been able approve' came back on time?

To be pedantic the MHRA did not reject the application. Application is still in progress.
GLPMA will when they gat around to it carry out a review. This review will then be sent back to MHRA.
We await the 'final decision' based on the findings of the GLPMA.
That is the procedure.
Significant delays can arise in these situations where additional reviews are sought.

What I have posted above is factual. That is all that matters.

Sweet FA to do with ' The ones who are most confident are also the ones who think negative sentiment means the SP will drop.'

Just exactly was the intent of your post Potters.

Regards

The MHRA did not reject the CTA. It has been passed on to the GLPMA for a review. That is not the same. Get your facts right please.

Acrivon which acquired Prexasertib recently has nigh double in share price in past month. Now sitting at 22 dollars a share.

A market cap of nigh 480 million dollars.

The AP3 platform enables the creation of drug specific proprietary OncoSignature companion diagnostics that are used to identify the patients predicted to benefit from its drug candidates.

The company's lead clinical candidate is ACR-368, a selective small molecule inhibitor targeting CHK1 and CHK2, is being advanced in a potentially registrational Phase 2 trial across various tumor types.

It is also developing its preclinical stage pipeline programs targeting critical nodes in the DNA Damage Response and cell cycle regulation pathways, including WEE1 and PKMYT1.

Good indications here for 737

MOLT-4 is a T lymphoblast cell line derived from the same patient as the MOLT-3 cell line (ATCC CRL-1552). The line was established from cells taken from a 19-year-old, male patient with Acute lymphoblastic leukemia (ALL) in relapse ( basic description here)

Background of the Invention ( Yes 1802)

T-Cell Acute Lymphoblastic Leukaemia (T-ALL) is a rare type of leukaemia that usually occurs in late childhood or early adolescence and is significantly more common in boys than girls. T-ALL is estimated to account for 10% to 15% of pediatric acute lymphoblastic leukaemia (ALL) cases and around 200 people are diagnosed with T-ALL in the UK every year. It is aggressive and progresses quickly: about 30% of T-ALL patients relapse within the first year during or following treatment and eventually die.

Current therapy for T-ALL consists of three stages: Remission induction, consolidation, and maintenance. Remission induction is intended to rid the blood and bone marrow of leukaemia cells, requires intensive chemotherapy and involves a hospital stay of approximately 1 month. Different combinations of chemotherapy may be used, but typically involve vincristine, dexamethasone or prednisone, and doxorubicin or daunorubicin (or a similar anthracycline). Depending on the patient's prognostic factors, regimens may additionally involve cyclophosphamide, etoposide and/or high doses of methotrexate or cytarabine. These intensive treatments kill off many of the normal bone marrow cells as well as the leukaemia cells, thus serious infections or other complications can occur during this phase. CNS treatment or prophylaxis is often started during the induction phase. Most often this involves intrathecal chemotherapy (most commonly methotrexate), potentially alongside high-dose IV methotrexate or cytarabine, and radiation therapy to the brain and spinal cord.

SDC compound
SD C1802 compound. From patent description.

Mice given Molt 4 as vehicle
Cyclophosphamide is a medication used as chemotherapy and to suppress the immune system. (In this sense in combo)

Results below. ( vastly shortened)

At the end of the study period T/C (test versus control) values were 26.2% for cyclophosphamide,

16.6% for Compound 29 50mg/kg BID,
26.8% for Compound 29 25mg/kg BID and

-2.1 % for the combination group.

' All treatment groups show significant anti-cancer activity as defined by the NCI, which states that any compound which has a T/C value of less than or equal to 42% has demonstrated significant anti-cancer activity.'

Very impressive in combo ie '2.1%' with a drug first approved for use in late 60's .

Whilst a predefined indication it in no way limits 1802 to T ALL. As from the above results it does indicate its efficacy in this particular type of cancer.

Regards

https://www.fiercebiotech.com/biotech/gsk-forging-ahead-2b-anti-tigit-plans-says-its-not-always-about-being-first

Mayhem55, spot on there!
Freedom of choice. Good to see that you have made a success, invested well and in good health. A stress free life promotes good health.

I am certain all will come good here.
Since CTA originally applied for is over 170 days now. Yes there can be delays especially when seeking further information. It should not take a further nigh 100 days and yet still no advance on this seeking of approval. What current status is this review at now?

News on developments could come at any time with regards to CTA.

We must allow time for 737 return and evaluation of data. This is imperative for both the CPF and any interested parties. There is a market here amongst the competition. GSK not having it all their own way.

This Jan 11th 23.
'A wide range of topics were discussed, including GSK’s preparation for upcoming FDA decisions for its RSV vaccine, potential first-in-class chronic kidney disease (CKD) anemia drug daprodustat and newly acquired JAK inhibitor momelotinib, as well as the company’s decisions to either withdraw or limit the use of cancer drugs Blenrep and Zejula. And an upcoming phase 3 readout for a combination of Zejula and GSK's PD-1 inhibitor Jemperli has, as Miels put it, a low chance of success. GSK’s mRNA vaccine collaboration with CureVac and the company’s appetite for additional M&A deals were also included.'

I like the way they put it as the company's decision. It is dictated to by the FDA.

Further info on GSK pipeline below.
https://www.fiercepharma.com/pharma/jpm23-conversation-gsks-luke-miels-rsv-and-mrna-vaccines-blenrep-and-zejula-withdrawals-plus

Regards

Mayhem55. Good post and agree with what you have stated. In reality it does become difficult.
The media is all so powerful in controlling our minds.
love is hate
War is peace
Freedom is slavery.

1984 was a book written by George Orwell a socialist, This book has been removed from colleges and universities. Most libraries too I will add.

there were two films made one around 1949 and a second version which is closer to the book which was made in 1984 starring John Hurt and Richard Burton.

HbD
' You can imagine how well that would go down. At least I quickly found out that speaking truth to power is a fool's errand.'

i have pointed out short cummings ie fact and truth, I would not say that i am fool in doing so. It made me unpopular, very much so with management. I will not submit a report based on lies, I will not sign paperwork on behalf of what another employee has supposedly done.

We want you to sign this document. No I will not! of course not liked by management and hence my file took up a whole draw as would normally account for around 30 employees.

That to me is integrity. I have tried to post examples of this in the past on here. Blocked by Cloudfare. I can't post things that would make your hair curl. Lies and cover ups.

Yes I can appear opinionated. I wont have people I know 5hat upon.
i have attended interviews volutaririly to assist. Then a meeting with between 3 and five management that try to play on words. No I will not give in. won 4 lost one and in that event i never lost out. Little people with big egos in management. Not one of them worth a bladder full of cold urine. Told them that too, but not do my credibility any good in their eyes.

Yes, I cleared work out of the way preventing action being taken by regulatory bodies. I were happy to get on and do the work correctly. I were told by several that management must have a different opinion of me and that I had redeemed myself.

Oh no, little people have their ego and hold a grudge. i have seen 2 in past 3 years way way past after I resigned. Hardly anyone on the pavement and they cross to the other side of the road. They are older than me and have retired. No eye contact made of course.

Scapegoats whereby a person suffers and the real culprit gets off scott free in the knowledge that he is safe due to the position he holds that not only protect him but also certain individuals higher up the food chain.

A little political. Not of much use for Sareum pipeline progression. We are a small company in a big pharma world. It is not an even playing ground.

Regards

Warthog4, Pigs are very productive their conversion of feed to weight gain is only bettered by chickens. They are quite intelligent animals. Very social creatures.

I will agree 100% there are bores in Westminster. Lies and BS is all they produce for their own gains. 80k a year is not over the top for an MP I feel. But most of their money obtained from using their positions of authority and 6 figure sums on annual expenses is.

Crisis after crisis develops of which they produce not a single worthwhile resolution. They are so distant from reality that I dont really think they have a handle on anything.

The country has been stripped of it assets. privatisation of power generation water and sewerage. Vast sums are made by investment companies. Understandable as the state pension is grossly inadequate. Effectively you are paying far more for services of which little is reinvested into the service. Those that do not have a private pension or money put by will suffer badly.
I remember around 2015 the chairman of eDF visited our station. The topic of pensions were bought up.
What we need he stated was more people to die off before they reach pensionable age.
My early days in the Industry the pension fund stood at circa 11 billion. As far as I know it is around 1 billion now.
There were two grades of pension as in 'white collar' and 'blue collar.'

Fairly early days and the white collar pension went broke. There was to be a vote to whether or not they could transfer into the blue collar pension. No vote took place. They ended up in the blue collar pension scheme.
Early days and there were over 240,000 employees contribution to electricity supply pension scheme. As far as I know that figure is now below 10,000.
Since Sizewell B went on line in the early 90's there has been no proper investment. Hinkley Point C will run over time and way way over budget.
Generation was made at a price some 7 years ago of 9.3pence per Kilowatt hour for Hinkley point C. This was the minimum Edf would accept to partially finance the project. Current generation revenue at this time was around 3p ish.
The 9.3p set price is also linked to annual inflation. Yes it will rise considerablyby the time it comes on line.

But bare in mind how can you have 1 station receiving a price of 9.3p and other stations receiving 3p?
Only way round this is to bring the others that are also owned by Edf to be made the same price.
Those that are in power want the majority of people to be poor and in debt. Especially the middle classes. It makes them far easier to control.

They see you as nothing more than a slave for their own gains and those similar to themselves. Nothing more than a great big trough with those in Westminster their snouts buried deep into it.

Regards and rant over on that one

HbD, as the human race farms animals it is not beyond reasonable doubt that the human race will farm humans.
When an animal has been used for reproduction to produce meat it will come to the end of its useful life. Take for example pigs. Several years of breeding then the animal is culled. Not as meat you buy as such but slaughtered and used n the making of garlic sausage. The reason for this is the flavour of meat is tainted. A pig can live for 25 years but reach the end of usefulness of around 5 years. Bores typically less than 3 years.
It costs money to treat an ageing population and we have a health system we cannot afford. Told to me by a doctor around 30 years ago. Something has to give he told me.

Regards

Good idea RMM it would be a landslide victory to 'None of the above'

Good posts from you earlier.
Unfortunately not much we can do apart from wait until news arrives on both fronts. As you correctly surmise GSK not interested in 737. Their goal is to commercialise the Tesaro pipeline. In addition I would also suggest as you have done that they also not want is available to a competitor whilst trying every trick in the book to commercialise the Tesaro pipeline in every indication they can.
There exists areas of high unmet need of which CHK1 have given good results with 737 and LDG.
There is vast amounts of research which has been carried out. Alternative pathway combination therapies which enhance the efficacy of a CHK1 inhibitor. Research has taken place, identification of alternate pathways and postulations to recommended types of combo treatment. Breast and Ovarian cancer being just 2.
We know that Michelle Garrett was an advisor to SO. We also there was much development post Chk1 with LDG. Much of this work post 2020.
With regards to a CHK1 inhibitor, cancer resistance to, P53 genetic mutations and effective combo therapy she is the mutts nuts.

Much of the research can only be downloaded into Pdf format, i van find no means of copying and pasting. These are full research papers. They set out objectives and investigations and deduce methods to enhance the effectiveness of not only CHK1 but also other inhibitors.
Some of these inhibitors need approaching via a different form as the current forms of inhibition are too toxic for human trials.

Enough of that, we just need to wait and see how long it takes for the return and also how SO have relayed material back with regards to genetics.

Just an observation here is the effectiveness of 737 in NSCLC. Not progressed and would be a severe headache to GSK had 737 been approved for treatment in just this area.

Regards

Good evening Andy. great to see you posting here again.

Good news will come just a question of when.

As a rough guide from AGM, TM around a couple/few weeks to return and between a day and a month to go through data.
2 weeks plus a day up to 2 weeks plus a month

Jan 12th to Jan 25th
Jan 12th to Feb 25th

Of course decision time of how to progress after this would follow and dare say included in the SRA737 RNS.
All looks pretty good, but am not sure on the in combo patents and where they have been approved as yet.

GSK having a slight spot of bother with the FDA over Jemperli. All part of their commercialisation of the Teasro pipeline.

https://www.fiercepharma.com/pharma/despite-high-profile-media-coverage-fda-balks-gsks-unprecedented-jemperli-proposal-rectal

From memory reduced milestone dropped SP around 20% and announcement of intent to return around 30%

A fifty percent increase plus in M/cap on decent CHK1 news is most certainly not out of the question. Around 40million market cap drop on news of return. circa 70p per share.
News of intent to on licence should recap at least half this and any news of an on license and of course will be dependant on who the pharma is ought to add around 100 million to market cap.
There are also some very interesting routes for Sareum to progress in a partnership with another pharma and the CPF/CRT.

We have great inhibitor. well researched and available orally. Nothing else near us.

Regards

A slight stumbling block for GSK ad Jemperli

https://www.fiercepharma.com/pharma/despite-high-profile-media-coverage-fda-balks-gsks-unprecedented-jemperli-proposal-rectal

The FDA do not appear overly keen on GSK Jemperli for rectal cancer.
Fierce biotec.

Steady Danny Pro Sareum. How can l say this , bit he is inclined to think outside the box.

With regards to data for 737 not sure that even under an NDA these companies would have been privileged to access the effect of patient genetics on Ckk1 inhibitor.

We now if we include the Chinese Chk1 and Acrivon granted phase 2 clinical trials 2 Chk1 inhibitors in progress. Both of which have been progressed in the past 2 years and a bit.

Of course the big in thing with CHK1 now is combo therapy.

If you are not fast you will be last.

As for the six that bidded for SO. It may well be that they not want Momo. It is not a massive market. As for the 737 side, negotiate with CPF.

Regards

There are many companies developing PD-1 and WEE1 PARPi. P53 checkpoint applicable to over 50% of solid tumour cancers, There are not many companies that have a CHK1 inhibitor highly researched and administered via the oral route with a 10 year patent left.

regards

The best person for AZ to speak to is an M Garrett.

Critical thinker on ADVN is of the firm opinion AZ will take it on.

AZ are in Cambridge hence close to Sareum

From AZ website.
Looking beyond DDR inhibitor monotherapy and led by our pre-clinical science, we have a broad range of clinical trials that are investigating the effects of DDR-based combination treatments. DDR therapies can be combined, to achieve better outcomes, to extend therapies beyond patients who are expected to respond to DDR monotherapy and to overcome resistance in the clinic.23

We also look at the effects of combining DDR and Immuno-Oncology (IO) agents. The inhibition of DDR pathways may prime an anti-tumour immune response, meaning combination therapies that target DDR and immune response pathways could result in improved outcomes.24 The diversity of our oncology pipeline spanning different scientific platforms of focus allows us to address some of the most common to the most life threatening and rare cancers and look beyond initial response to long-term outcomes and, eventually, a potential cure.

AZ into prostrate , Ovarian, lung, pancreatic and breast.
capivasertib - is an AKT inhibitor and heavily suggested via investigational work that an AKT inhibitor may prove to work well in breast cancer in combo with A CHK1 inhibitor. Effectively the AKT inhibitor seeks to address some of the problem with CHK1 resistance and alternative pathways.
i would not say for definite as can only be pure speculation.

The potential for combo is there with AZ and its current pipeline, so in effect I certainly would not rule some sort of collaboration out. They may very well be in discussions.

The advantage here is CHK1 and gemcitabine have already provided good results in both efficacy and safety with LDG. Not far away from the clinic in this respect, at the same time leaves immense scope for further in combo development.

Regards