Member Info for Gunner68

The ph1 tox studies took way longer than expected and Thoth2 was going mental over it R.I.P as per the norm with SAR nothing is ever clear cut we will have to wait till Q4 for the results but they will know beforehand how good it has performed as for funding only the BOD will know what’s happening again expect the worse be happy if all comes good

GLA

Tbh the first thing I thought when the red dot came up was ffs not again Fridays normally a bad day for SAR with an RNS so was more than happy it’s wasn’t a tox failure

Come on Sar make it our year

GLA

About Fast Track Designation1

Fast track is a process designed to facilitate the development and expedite the review of

drugs to treat serious conditions and fill an unmet medical need. The purpose is to get

important new drugs to the patient earlier. A drug that receives Fast Track designation may

benefit from things such as: more frequent meetings with FDA to discuss the drug's

development plan and ensure collection of appropriate data needed to support drug

approval; more frequent written communication from FDA about such things as the design

of the proposed clinical trials and use of biomarkers; eligibility for Accelerated Approval

1 https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-

review/fast-track

and Priority Review, if relevant criteria are met and; rolling review, which means that a drug

company can submit completed sections of its Biologic License Application (BLA) or New

Drug Application (NDA) for review by FDA, rather than waiting until every section of the

NDA is completed before the entire application can be reviewed. BLA or NDA review

usually does not begin until the drug company has submitted the entire application to the

FDA.

Hopefully we will get the go ahead not looks like the FDA want new drugs quicker

GLA

The Company has maintained an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to conduct a Phase 1 trial in patients with acute myeloid leukaemia and myelodysplastic syndromes and retains sufficient stock of SRA737 capsules to conduct a trial.

• Notice of Allowance received from US Patent and Trademark Office for an application protecting the crystal form of SRA737 drug substance, extending patent protection until at least April 2041.

Now if they get the go ahead with this could be interesting

All looks good on paper we just need money coming in

GLA

An RNS to say dosing has actually started would be welcome instead of everyone guessing no doubt paperwork and animal prep will be needed before the actual event this threw a lot of investors last time and I’m pretty sure most would appreciate this information as that is the real 16 weeks everyone is going to be looking and waiting for

GLA

Probably hoping one day the peer review will be published another red herring

Https://www.fiercebiotech.com/biotech/accropeutics-tyk2jak1-inhibitor-hits-psoriasis-endpoints-chinese-biotechs-first-phase-2-win

Hi PCS this link is also in the article you posted this was the Chinese tyk2 trial that started a week after 1801 in Oz now completed a ph2

GLA

And a happy Xmas to you and your family let’s hope SAR can actually capitalise on what we have in 2026

GLA

Hey up PCS hope alls well is well and good to see a good rise today I’ll actually stick up for TM I found him very chatty and learned more in the 10 mins talking to him especially about timelines which have never been mentioned before

Was also good to see SP snd JR upbeat and meet other shareholders including some big hitters

Only criticism is the time allocated and would of been nice for the Qs submitted to be answered there and then instead of waiting a few weeks also a bit more time to chat to more of the BOD

All the best for 2026

GLA

The 5 day study will be more like 6 weeks plus

Last time a few met up for a coffee and chat my train back up north is mid afternoon so if anyone fancies a couple of pints I’m happpy for that

I’ll be there

Laz I for one will be more than happy to be red faced but after 12 years and the sp lower now than then I’m more than happy for Parker to go considering we are meant to be best in class and including 737 what’s the point if the company cannot get any financial gain for them . They will still have the best part of 6 months to replace him till the results of the tox studies become available and if we wait as long as it’s taking for the peer review to appear (shortly) then no rush and a good saving of salary

GLA

Yes very interesting to see if this is the case 2 years ago we were at 60p now look I would like to hear what exactly they think shareholder value is and remember when TM did say he thought 1801 was worth 800m but then miraculously it was denied. 2 years have moved on and still no income I believe HNWI do not trust Parker and back then I was going to call for him to step down 2 yrs and nearly an 80pc drop we need someone new in and before anyone says it will hold us back Sareum will have at least 5/6 months before results are released from the new tox study to sort it out also due to them being a small group they will all know what is /is not happening

New year new CEO let’s get as many to the AGM to let this happen

GLA

Woodlands prepare to be disappointed probably about 10 people on the room Tm snd JR looking bored and SP talking sh@te and then all looking like rabbits in headlights when asked a question

Kat they have already said it’s still 16 weeks no short cut then a short in human trial

Good job I’ve brought the tickets now at this rate will have nowt left hopefully a few will make it especially those who want Parker out if no good news by the 9th

Tyk toc

Potnak is that not just the tox studies how long would the human studies take on top of that are we looking at 2027 before a deal ?

What is their definition of brief ? A bit like shortly I guess

Question 21:

Since the halt was for safety in the control group, making the formulation void, what is the Board's assessment? Is a full new Phase 1 trial for a replacement product now the most likely requirement, rather than a simple bridging study?

No – the formulation in the toxicology study is different to that which was used in the clinical trial or will be used in any future clinical trial in humans.

We are separately working on optimizing the formulation for humans and it may be that we conduct a brief pharmacokinetic study in humans to look at blood levels achieved with any new formulation prior to conducting any further efficacy studies.

So do we have to do another 16 week study ?

Also considering the Q&As have been up looks like the enthusiasm has totally left the SAR ship

Are you really that surprised ?