Member Info for carter19

It is amazing how often we have had another hurdle to get over even though we are progressing, albeit slowly. Then one thinks, what spanner will be thrown into the works next.

Bobbler , as you have stated, infection, there are other scenarios that can happen as well that are not a huge problem, here’s hoping

They are still making staffing cuts, got to be hopeful of a rebound soon.

Sell up then, do you want all of us to tell you what to do.

There can be a multitude of things that can go wrong, contamination, the animals picking something else up, some virus etc. We will have to wait, we always seem to get another last hurdle.

• 2. Consultation with Regulators and Advisors (Month 2-3)

Goal: Confirm regulatory expectations before restarting.

Actions:

• Sareum's non-clinical and regulatory teams meet with MHRA preclinical assessors (or their consultants).

• Discuss:

• Whether the study can be repeated in part or must be fully redone.

• Any required modifications to formulation, dosing, or animal model.

• Whether existing partial data can support a future CTA.

Outcome: Agreement on a compliant plan to restart the GLP tox study.

Sr 1. Immediate Data Review (Weeks

1-4)

Goal: Determine what actually went wrong.

Actions:

• Retrieve all raw study data, dosing records, necropsy reports, and lab logs from the CRO (contract research organisation).

• Conduct a pathology re-review with independent toxicology experts.

• Check whether findings correlate with vehicle composition, handling, or animal cohort differences.

• Assess if the control batch was contaminated, expired, or misformulated.

Outcome: Identify the root cause - crucial for defending the study's integrity to regulators and investors.

I took these of Ai

• The positive takeaway is that the drug itself isn't suspected to be the cause of the problem

- the safety findings were more common in controls.

• Sareum's language ("highly unlikely to be related to SDC-1801") is strong — they're confident the drug's safety profile remains intact.

• If confirmed, the scientific setback is procedural, not pharmacological - i.e. the delay is technical, not due to toxicity.

• 3. Financial and strategic implications

• The delay means extra costs (new contractor, study repetition, expert reviews).

• Sareum may need to raise additional funds if cash reserves were budgeted to last only until early mid-2026.

• Investors often interpret these events as short-term negatives due to timing and uncertainty

- even if the long-term drug prospects remain strong.

Ask any thing

• 3. Possible explanations

This can happen — and it usually points to issues unrelated to the drug itself, such as:

1. Vehicle formulation issues - The "inactive" solution might have degraded, been contaminated, or have had a pH, solvent, or excipient problem that caused reactions.

2. Handling or procedural error - Dosing errors, incorrect administration (e.g., injection technique, tube placement), or infection could affect one group more than others.

3. Statistical or random variation - With small group sizes, random chance can produce apparent differences.

4. Mislabeling or mix-up - Control and treatment groups could have been accidentally switched or handled differently.

5. Environmental factors - Temperature, cage placement, or diet differences can sometimes create misleading results.

4. Why Sareum ..rted the study

The bit I havnt got Sadold, how come the trial tested isn’t the problem, but the placebo ones are the problem, this is the part that Im struggling to quantify.

Many people can be clever but they are not always smart and make terrible decision, ie we might not be here this time next year, what a stupid statement

I’ve watched it 4 or 5 times Potnak, fantastic race. Did you know which top athlete ran it last year ?

Ha Ha, I laughed at that one. Your map reading skills improved, I take it.

Meaning fell shows, I meant.

Obviously your saying fell shoes Potnak, not normal adidas etc.

Only been up Ben Nevis once, beginning of October, 10 degrees at the bottom and -12 degrees at the top with wind chill. I went passed many walking down with trainers on, 1 and a 1/2 ft of snow as well on the top.

Sounds good 👌

Yes, but other large investors sell and drag the share price down.

Well done on you with your profit.