Member Info for carter19

Sadoldgit gets fed up with some of those that just spout rubbish. So he is more than likely taking time out

No surprises there, Blackrock own 6.7 % of JP Morgan.

They aren’t giving us an easy time, not sure if Blackrock are out now, JP Morgan have just come on the scene, if the budget is dire, who knows when it will stop.

That’s the reality of aim.

Two big sells today, I wonder who is off loading still.

That didn’t take long, back in the high 160’s again. May have to wait a little longer

I’ve found that the debt facility is £0.72 million with £1.07 cash ending May 2025. The burn rate has also slowed down. We await new contracts.

Ok, are you aware of what that might be.

Hi Adastra, what’s your thoughts on the borrowing if the Company has to ramp up productivity if orders increase. I’ve seen that the company has a small cash reserve. It’s difficult for new companies not to raise funds through share issues.

5 minutes with you and you’d be asking people where the nearest guillotine is.

Fault outcome

Who pays

Usual cost recovery for sponsor

Clear CRO fault (procedural / contamination)

CRO pays all costs

100% refund or free repeat

Shared fault (e.g. vehicle formulation supplied by sponsor)

Shared

50–75% reduction

Unclear / “Act of God” cause

Sponsor pays

0–25% reduction (negotiated goodwill)

Sponsor fault (e.g. supplied bad material)

Sponsor pays

0%

My bad if already posted, just looking through Ai

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🧩 For Sareum specifically

Given that:

• SDC-1801 already passed human Phase 1 without safety issues.

• Only the control animals were affected.

• Sareum plans to repeat the study with a different CRO and expects to cover the cost internally.

…it’s very likely this is a Redx-type situation: an avoidable but not fatal delay (probably a few months to half a year).

⸻

Would you like me to outline a probable timeline impact (e.g., base case vs worst case) on Sareum’s move to Phase 2, based on how long these other companies’ repeats took?

⸻

🧪 4. MorphoSys AG (Germany) — 2014

What happened:

• Unexpected immune findings in monkeys, later traced to a vehicle formulation instability that occurred during shipping.

• Only the control and low-dose groups were affected.

Outcome:

• Investigation confirmed degradation product in vehicle.

• Programme advanced after repeat tox study; no regulatory penalty.

✅ Lesson: Stability problems in formulations can generate false signals; repeat studies are accepted.

⸻

🧪 3. Pharvaris N.V. — 2022

What happened:

• Toxicology findings appeared inconsistent with earlier studies.

• Investigation found CRO procedural errors (mis-dosing and sample mis-labelling).

• Study stopped and repeated at a new CRO.

Outcome:

• Programme delayed by 6 months.

• Ultimately regained regulatory clearance to restart clinical dosing.

✅ Lesson: Regulatory bodies are pragmatic when an issue is clearly traced to the CRO and not the molecule.

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🧪 2. Hutchison China MediTech (Chi-Med, now Hutchmed) — 2017

What happened:

• During preclinical work on a small molecule, several control rats developed liver findings.

• Root cause: a bad batch of feed at the CRO had fungal contamination.

• The problem affected only the control group, as their cages were in one location.

Outcome:

• GLP study was invalidated and repeated.

• No findings in the repeat study → programme advanced.

✅ Lesson: Husbandry and environmental issues can mimic drug toxicity; regulators accept repeat data once verified.

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🧪 1. Redx Pharma (UK) — 2020

What happened:

• Redx was running a GLP toxicology study for its ROCK2 inhibitor (RXC007).

• Unexpected findings arose in both groups, but detailed investigation showed the vehicle solution (placebo) had precipitated and caused irritation in the control animals’ GI tract.

• The CRO had prepared the vehicle incorrectly.

Outcome:

• Study had to be restarted with a corrected vehicle.

• Delay: ~3 months.

• RXC007 went on to complete Phase 1 successfully and entered Phase 2 trials in 2023.

✅ Lesson: Vehicle errors happen and can cause alarming but ultimately non-critical delays.

When you say comms isn’t their forte, I personally think that’s a right cop out, if you answer something honestly and don’t skate around the periphery, it can be easily done. They choose not to, that’s putting it in simplistic terms. They got off lightly the last time at the AGM from the guys that went down, as they gave them the benefit of the doubt.

Bit of Irish luck wouldn’t go amiss, by grandfather was Irish.

😁 keep that 5 piece clover in your wallet.