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Final part

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Rejection Rules & Expected Focus Timeline

Would they have to announce a rejection via RNS?

No. AIM rules require disclosure of information likely to have a significant effect on share price. However, since the pending application was never public, a rejection is a gray area. Most companies would not disclose it; they would simply resubmit with additional data and say nothing.

Reconstructing the SGC Priority Timeline

January 2025: Phase 1b expansion cohorts initiated in three indications (TNBC, soft tissue sarcoma, and SGC)—all three were nominally equal at this point.

October 2025 (ESMO): Phase 1a data in SGC showed median PFS not reached and a disease control rate of 91%. This is likely where SGC was internally confirmed as the registrational focus.

May 2026: In preliminary results, Avacta explicitly described SGC as "the lead indication selected."

Expected ODD Application Window

A well-run regulatory function would have filed an SGC ODD application in Q4 2025 or Q1 2026 following the compelling ESMO data.

If filed in Q4 2025 \rightarrow Response expected Q1/Q2 2026.

If filed in Q1 2026 \rightarrow Response expected Q2/Q3 2026.

Conclusion: If an application was filed in that window, a decision should already be imminent or received. The absence of an RNS announcing an ODD for SGC suggests they either haven't filed yet, received a deficiency letter requiring more data, or are strategically holding the news to coordinate with a partner deal.

Is it likely that they will get ODD?

Yes, highly likely. The criteria are straightforward:

Prevalence: SGC affects well under 200,000 Americans annually.

Clinical Plausibility: Supported by Phase 1a/1b data showing a 92% DCR and immature PFS trending well above benchmarks.

Existing Treatments: No established standard of care in SGC.

Precedent: Avacta has already successfully obtained ODD for AVA6000 in soft tissue sarcoma.

Outright rejection is unlikely given the data quality. The main risk is a prolonged silence, which loops back to tactical timing or data-gathering delays.

Continued

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Key Terms Defined

ORR — Objective Response Rate: The proportion of patients with a measurable tumor reduction meeting predefined criteria (typically confirmed partial or complete response by RECIST).

ODD — Orphan Drug Designation: An FDA designation for drugs targeting diseases affecting fewer than 200,000 people in the US, conferring 7-year market exclusivity, fee waivers, and tax credits.

Orphan Drug Designation (ODD) Timeline for SGC

If Avacta applied for ODD for SGC, how long would it take, and what is the likely timeline?

Timeline: 3–5 Months in Practice

The FDA's target is to respond to ODD requests within 90 days. Real-world timelines are closer to 3–5 months when factoring in routine deficiency letters requesting additional information.

Application Requirements

SGC easily qualifies on prevalence grounds. The core of the application is the scientific rationale, which must establish a medically plausible basis for expecting the drug to be effective. Avacta is in a strong position here given the Phase 1a/1b data already in hand.

Strategic Implication

If they filed an ODD application for SGC today, they'd likely have it in hand by Q4 2026—before the cash runway expires in Q1 2027. It would also materially strengthen partner negotiations.

Is the Application Public?

No. ODD applications are strictly confidential until a designation is granted. The FDA only publishes information after a positive decision. Rejections and pending applications are never disclosed. This makes it a genuine binary catalyst that could arrive completely unannounced via an RNS.

Continued -the below summary was why I was interested in accelerated approval.

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Summary: Accelerated approval could move the commercial launch forward by 3–5 years (from ~2031 to ~2027–2028). However, the probability is low given the weak confirmed ORR (~12.5%) and the absence of an ODD in SGC.

Continued

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Full Approval PathAccelerated Approval Path

Phase 1b PFS Maturity (Gating)Q4 2026–H1 2027Not required (could submit on existing ORR/DCR)

Partner DealH1–H2 2027Still needed to fund BLA prep + confirmatory trial

BLA Filing2028+H2 2026–H1 2027 (if FDA agreed)

FDA Review (Standard 10–12 mo)~20292027–2028

Confirmatory Trial CompletionN/A (pivotal IS confirmatory)Still required (same pivotal PFS trial)

Full Approval2031–2033Accelerated: 2027–2028 (Full: 2031–2033)

Continued

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How Would the Timeline Change if Accelerated Approval is Received?

The Accelerated Approval Question

The FDA agreement dated June 25, 2026 explicitly specifies PFS as the sole primary endpoint for full approval. Accelerated approval requires a separate FDA agreement on a surrogate endpoint (like ORR or DCR), and that conversation hasn't been publicly disclosed.

Assessing the Evidence

Arguments in favor:

SGC has no established standard of care—a classic setting for accelerated approval.

Recent FDA precedent shows rare-tumor approvals on very small single-arm datasets (e.g., zenocutuzumab was approved with a 36.8% ORR in just 19 patients). AVA6000’s n=38 with 92% DCR is structurally competitive.

In 2025, 6 of the 16 FDA cancer drug approvals enrolled fewer than 100 patients, mostly via single-arm trials with Orphan Drug Designation (ODD).

Arguments against:

The FDA has explicitly directed them toward PFS. Changing course requires reopening regulatory dialogue.

The confirmed ORR in the n=32 pivotal-population cohort is only 4 partial responses (~12.5%). That is a weak ORR for an accelerated approval submission; the high DCR (92%) reflects stable disease, which is not a standard accelerated approval surrogate endpoint.

AVA6000 has ODD in soft tissue sarcoma but not yet in SGC.

Timeline Comparison: Full vs. Accelerated Path

Continued

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Pivotal Trial PFS — The Approval Endpoint

This is where the real investment horizon lies:

Phase 1b PFS Maturity + Partner Deal Close: Avacta has explicitly stated it will only advance to a pivotal trial with a partner. The regulatory clarity is expected to strengthen ongoing partnership negotiations. A deal close in H1 2027 remains the floor based on prior analysis.

Pivotal Trial Design and Activation: Once Phase 1b data mature and a partner is aboard, IND amendments, site activation, and enrollment ramp for a randomized pivotal trial typically take 12–18 months before the first patient is dosed.

Pivotal PFS Endpoint: The pivotal trial would enroll both first- and second-line patients in the most prevalent subsets of SGC, with PFS as the sole primary endpoint for full approval. In a randomized controlled trial for SGC—a rare tumor—enrollment alone is likely to take 2–4 years given disease prevalence. Then you need event-driven PFS maturity.

Bottom line on pivotal PFS determination: Realistically 2031–2033, assuming:

Phase 1b data mature: H2 2026–H1 2027

Partner deal closes: H1–H2 2027

Pivotal first-patient-in: 2028–2029

Enrollment completion + PFS maturity: 2–4 years post-FPI

Key Risks to This Timeline

Upside (Accelerated Approval): Avacta could seek accelerated approval on ORR/DCR earlier. The 92% disease control rate and confirmed partial responses are arguably sufficient. However, the FDA agreement is currently for full approval based on PFS, and there is no indication an accelerated route has been agreed upon.

Downside (Cash Runway): The £10M raise in March 2026 only extends the cash runway to early Q1 2027. If Phase 1b PFS doesn't mature before cash runs out and no partner deal closes, Avacta will need another dilutive raise. The convertible bond October 2026 pressure point is the more proximate risk.

Looks like the post with the link to Claude was removed. I assume I broke some forum rule. Perhaps it helps others so below is the somewhat long winded analysis spanning multiple posts

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Can you predict when PFS is likely to be able to be determined for Avacta's AVA6000?

Phase 1b PFS Maturity — The Immediate Gating Event

The question is two-layered: when will Phase 1b Progression-Free Survival (PFS) data mature (triggering a pivotal trial go/no-go), and when will the pivotal trial itself generate mature PFS data for full approval?

Current State (As of June 25, 2026 BIO Data)

The n=32 pivotal-population SGC cohort has been assessed for best overall response, but median PFS data are not yet mature. Progression events continue to be collected and overall survival data continue to mature.

At ASCO (June 1, 2026), 9 patients were continuing treatment and 11 further patients remained in follow-up for disease progression, out of 38 evaluable patients.

Analysis: As of mid-2026, ~20 of 38 evaluable patients have not yet progressed. For a median PFS to be determinable, you need >50% of the cohort to have experienced a progression event.

Expected Phase 1b Median PFS Timeline

The Phase 1b SGC cohort began enrolling in early 2025. The earliest patients are likely ~18 months into follow-up by now.

The Benchmark: Conventional anti-cancer therapy in pre-treated SGC yields a median PFS of approximately 3.5 months. Earlier Phase 1a data showed Avacta trending toward doubling that benchmark.

If median PFS is in the 7–10 month range (roughly 2× comparator), the majority of Phase 1b patients enrolled in H1 2025 should be progressors by now. The fact that 20/38 remain progression-free suggests median PFS is materially longer than ~12 months in this cohort, or enrollment ran longer into 2025 than expected.

Realistic Estimate: H2 2026 to Q1 2027. The "data not yet mature" language with 20 patients still progression-free suggests the readout is probably Q4 2026 at the earliest, and more likely H1 2027.

Thanks Jam. Perhaps Claude got it wrong buy it looked like the accelerated path would improve the timeline (and ODD for SGC would be important to qualify). Hopefully LSE allow a link to the chat as it does not format well when pasted here

https://claude.ai/share/416aa227-b661-4ad7-bd4c-80aeb8948c87

Cheers

*filed it, not failed it... Auto correct!

Thanks - the background to this question was the below Claude comments. My hope is of course the last suggestion for a delay (awaiting partner release). I was hoping if we knew if they had failed it we could derive which option would be most likely. Cheers

Likely ODD application window for SGC:

An experienced regulatory team would file an ODD application for the lead indication as soon as clinical data are sufficient to support the scientific rationale — you don't wait for Phase 1b completion. Given the Phase 1a SGC data were compelling by ESMO October 2025, and given Avacta already had ODD experience from the soft tissue sarcoma application, a well-run regulatory function would have filed an SGC ODD application in Q4 2025 or Q1 2026 at the latest.

If they filed in Q4 2025, the 90-day target puts a response by Q1 2026, with real-world slippage to Q2 2026 at the outside. If they filed in Q1 2026, a response would be expected Q2–Q3 2026.

The implication: if an application was filed in that window, a decision — positive or silent — should already be imminent or potentially already received. The absence of an RNS announcing ODD for SGC is therefore slightly surprising, and points to one of three things: they haven't filed yet, they filed and received a deficiency letter requiring more data, or they're strategically coordinating disclosure with a partner deal or other catalysts. None of those are particularly alarming, but it's a loose thread worth tracking.

Thanks VS. I thought the ODD was specific to STS and they would need to apply again for SGC?

Hi All,

Whilst researching AVA6000 using Claude, it noted that key to the timeline for when the drug could be fully approved largely depend on whether accelerated approval would be granted. When I asked it to determine what would be needed to get this type of approval, it noted ODD or high ORRs. Does anyone know if Avacta have applied for ODD for AVA6000? Claude seemed to indicate that it would take 90 days for approval /rejection and that Avacta would easily clear this hurdle. It was surprised that this had not been announced yet.

Cheers

Thought I would share that Charles mentioned on TG that he is doing an interview with UFO and also an article. He could not promise the exact release date but should be next week.

Cheers

Looks like a good RNS. Happy if TM1 can focus on recycling instead minerals exploration. 10M USD seems like a nice addition even if the shares are locked in until 2025.

Does anyone have a link to the TG group?

Hi All,

Anyone got an invite to the TG group?

Cheers

Hi All,

I must admit I was always hoping GGP would buy UFO so we would get a stellar management team building this mine (I bet most of us in UFO also are in GGO)

Here's to a short duration until the mining licence lands. :).

Cheers

Hi Wentsland,

I am relaxed about a possible placing IF it is done after we get the RNS stating that the mining application is approved and we can re-rate first. If the civil works would cause use to have to go to the market before that, they should simply wait with that phase.

Cheers, STR

Trippy, is it not because we had a mining plan during the last MRE? Since then it has moved to Optimisation status and can theredore not be used fo the resource/reserve conversion? Might have that wrong...

HL showing 18.84% up. You have to have nerves of steel with this share!