Member Info for B2HS2L

It's what they haven't said in an RNS, or have said in an unguarded moment in a live presentation.

It's listening to what's said and not acted on, - or not said and performed.

It's the picking and choosing of questions they want to answer before a Q/A session.

It's the avoidance of answering awkward questions during questions from the floor (ie at AGM).

It's what some posters report they overheard board members say after a meeting.

It's what appears believable or not believable on social media.

Like details of the Telegram Group visit to Avacta Scale Space 18.10.23, and the reporting of what their questions and answers may have been.

It's copying the few notes taken from the 30th October 2024 R&D Spotlight focusing on pipeline advances Q/A session, (thanks jive) because that session was never made available to sh.

It's being inquisitive to the nth degree.

Each scrap has to be evaluated T/F and boiled down into 'Do I buy more, should I own less' decisions that should be constantly addressed.

Touk - 'It’s a good honest look at the facts (or as little facts as we are told) and taking into account events over the past 5 years'.

Facts are largely to be found in RNS's, but you need to know so much more than facts to stand a chance of seeing your stake back with AIM companies.

As close as the shorters algorithm allows Awax.

What a way to find out your Algorithm is crap.

Thursdays webinar and the short notice announcement.

Might American Medics and drug manufacturers be organising a reponse to the news Trump is signing an EO re cost of drugs globally, apparently without warning.

Does CC / MM want to get the webinar out the way soonest, so CC can join confederates and outraged manufacturers on the war path to the white house in the coming weeks.

WTFDIK.

What sort of time scales would be optimal for NASDAQ barnstorming.

Maybe a timetable for a dual listing is asking too much as it depends on opportunity or pre-planning.

Perhaps late 2025 early 2026?

The problem as ever, is product development is in the shop window (AACR etc), and developing as fast as R&D personnel can sprint.

Investors want to hear about commercial progress, timescales, funding etc. and that isn't up for discussion.

Deep dive AACR posters it is then.

Any new info would need an RNS.

Private investors interaction with the company is problematic.

If this is the best investor relations service Avacta can afford, private investors feel the company is being ripped off for the 'services'

provided by ICR Healthcare, and THRUST Strategic Communications.

If you want a good PI investor relationship, don't employ these two, because they are not providing the services the company are paying for.

PI's are fed up with no responses to emails, and are effectively being ignored.

It would reduce the tax payable to US Govnt, unless he increases the amount of tax per transaction.

That's difficult if he implements 'most favoured nation' approach.

Large change to this Executive Order due, and he hasn't signed it yet.

It's as likely to happen as regulating US gun laws.

You would think he knew that after botched assassination attempts.

'Regulatory Oversight: Decisions to stop must involve consultation with regulatory bodies (e.g., FDA) and align with guidelines like those in the FDA’s "Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees" (March 2006), which emphasizes rigorous statistical boundaries for early stopping.'

Document found here:

https://www.fda.gov/media/75398/download

Https://www.clinicaltrials.gov/study/NCT04969835?tab=table

Open 'Researcher View' tab

Outcome measures:

Primary (Current)

Secondary (Current)

FYI

The FDA’s "Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry" (November 2019) supports such approaches, noting that early termination for efficacy is feasible if statistically and clinically justified.

Ethical and Practical Considerations:

Stopping for efficacy in Phase 1 may be driven by ethical imperatives, such as ensuring participants in placebo or control arms (if applicable) receive the beneficial treatment.

It may also be a strategic decision to reallocate resources to a more advanced trial phase, especially for conditions with high unmet medical needs.

Challenges and Cautions

Limited Sample Size: Phase 1 trials typically involve small cohorts (10–100 participants), making efficacy signals less statistically robust.

Early termination risks overinterpreting preliminary data, which may not hold in larger studies.

Focus on Safety: Efficacy is a secondary or exploratory endpoint in Phase 1, so stopping for efficacy requires careful justification to ensure safety data collection is not compromised.

Regulatory Oversight: Decisions to stop must involve consultation with regulatory bodies (e.g., FDA) and align with guidelines like those in the FDA’s "Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees" (March 2006), which emphasizes rigorous statistical boundaries for early stopping.

DSMB Role: A DSMB (Data and Safety Monitoring Board), if involved, would evaluate whether efficacy data meet predefined thresholds and balance this against safety and trial objectives, as outlined in the NINDS Guidelines for Monitoring in Clinical Trials (NIH, updated February 20, 2025).

Examples and Precedents

While rare, there are precedents, particularly in oncology and rare diseases:

In some Phase 1 trials of targeted therapies (e.g., immunotherapies like checkpoint inhibitors), dramatic responses in early cohorts have led to protocol amendments or early termination to initiate Phase 2 studies.

For rare diseases with no existing treatments, strong efficacy signals in Phase 1 may prompt discussions with regulators to expedite development, potentially stopping the trial to redesign it as a pivotal study.

Conclusion

Stopping a Phase 1 trial for efficacy is possible but uncommon due to the trial’s primary focus on safety and small sample size. It requires predefined stopping rules, robust statistical evidence, ethical justification, and oversight by a DSMB or similar body. Guidance from the FDA and NIH, such as the documents mentioned, supports such decisions when appropriate. If you have a specific trial or context in mind, I can delve deeper or analyze relevant data!

Note: - I haven't verified the above, but surprised so much info is available.

I would hope Scientific Advisory Board and CC are aware.

RNS 28.04.2025 contains

"In patients with salivary gland cancers (SGC, n=11) treated at or above the dose level of 250 mg/m2, AVA6000 demonstrated multiple confirmed responses and a disease control rate of 91%.

Median progression-free survival (PFS) has not yet been reached, with median follow-up exceeding 25 weeks (25.3 weeks, 5.9 months).

These FAP-Dox PFS results compare favorably to recent benchmarking data in this patient population presented at ESMO 2024, with a reported PFS of 3.5 months (15 weeks)

+++

So we currently stand at 27 weeks, and double the previous PFS = 30 weeks, due by the end of May.

There is no estimation of when PFS for SGC will be reached that I know of.

At 30 weeks, if asked, will the FDA agree that double the prior PFS for SGC is significant, or will they desist, stating Avacta is still trialling SGC in a Phase 1b trial which is incomplete?

The following Grok enquiry provided a full and unexpected result:

Grok info request: Can a phase 1 medical trial be stopped for efficacy

Response:

Yes, a Phase 1 medical trial can be stopped for efficacy, but it is rare and typically not the primary focus of such trials. Phase 1 trials primarily aim to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug or intervention in a small group of healthy volunteers or patients. However, early evidence of efficacy may emerge, and under certain circumstances, this could lead to a decision to stop the trial. Below are key considerations:

Circumstances for Stopping a Phase 1 Trial for Efficacy

Unexpected Overwhelming Efficacy:

If interim data show exceptionally strong efficacy (e.g., significant clinical improvement in patients with a serious condition), ethical considerations may prompt stopping the trial to avoid withholding a clearly beneficial treatment from participants or to accelerate progression to Phase 2.

Example: In oncology, if a Phase 1 trial for a novel cancer therapy shows dramatic tumor responses in a majority of participants, the trial might be halted to redesign the study or move to a later phase.

Predefined Stopping Rules:

Although uncommon, some Phase 1 trials, especially in adaptive designs or those with exploratory efficacy endpoints, may include predefined criteria for stopping due to efficacy. These are outlined in the trial protocol and monitored by a Data and Safety Monitoring Board (DSMB) or equivalent oversight group.

For instance, a protocol might specify that if a certain proportion of participants achieve a predefined clinical outcome (e.g., biomarker response), the trial could be stopped to evaluate next steps.

Adaptive Trial Designs:

Modern Phase 1 trials increasingly use adaptive designs, allowing modifications based on interim results. If efficacy signals are strong, the trial could be stopped early to transition to a Phase 2 study or to expand the cohort to further evaluate efficacy (e.g., in seamless Phase 1/2 designs).

Con

It just seems to me, very slow progress for all the data that you all think is exceeding all expectations that has been shown over the last 3-4 years.

Covid and all the changes in product development and time spent pursuing AVA3996 didn't happen apparently.

FWIW

It is NOT a fallacy... that the original 'Pure fallacy but...' post amassed 28 recs not 14. - so my kite is twice the size you thought it was.

I will be Licensing posts beginning 'Pure fallacy but...' starting now.

You must stop using it without a license henceforth, else you will be hearing from my solicitor.

If you fail to desist, - then the Mafia, and fingers get broken ... soon... Monday lunchtime if Luigi is sprung from Broadmoor by role call...

If you continue, the Spanish Inquisition visits.

And you don't want to be in when these guys call, - there new name is the Bob squad.

1-800-666

Fallacious? - try me.

Anyone Recommending this post will have read how it's possible to waist half an hour, because someone thought a post beginning 'Pure fallacy but...' should be taken seriously.

Indeed.

The following is a big improvement on ADC's:

Source: 08 Nov 2024 - Video presentations from R&D Spotlight: ‘Next Generation of pre|CISION® Medicines’

https://avacta.com/video-presentations-from-rd-spotlight-next-generation-of-precision-medicines/

10:13 on slide 'Cytotoxic technology delivers cytotoxic drugs directly to the tumor while protecting healthy tissue'.

Advantages

. Small molecule manufacturing and timeline/COGM (cost of goods manufactured)

CC, commenting on this bullet point stated:

"What that statement means and why that is important, is that the price tag for this drug (AVA6000), is one tenth of the price tag for an ADC drug.

ADC's cost a lot of money in the clinic"

+++

Many BP have paid big bucks already for ADC based technology, and have not yet recouped that investment.

Whether they will ever get their money back let alone make a profit remains to be seen.

How that affects their attitude should AVA6000 phase 1b be successful will be interesting.

Agreed, much more value released should Avacta successfully reach AVA6103 ph 1 results.

However Avacta has to get past the successful AVA6000 phase 1b results scheduled at end of this year without being bought out for that to happen.

A hostile takeover bid doesn't seem likely, but we are discussing the future of a market disruptive product - the PDC preCISION platform.

It's cheaper and faster to produce, places all the payload exactly where it's required, and much less complex to develop than ADC's.

We don't know the interest levels from BP, but my guess is some will concern themselves the cost of a buyout will balloon, if they don't accept a lot of risk and bid after phase 1b.

Some might feel the writing is on the wall for ADC's.

Let's see.

You may be right there H4.

However from 13:59:

CC et al would be best advised to have as many deals in the safe as possible, so that come decision time, they know exactly what's on the the table.

If you were to define Simon Bennetts job, he should be stuffing CC's safe with as many deals as possible ready for signature when the time was right.

As he still has a job, I'm assuming deals contingent on successful Phase 1b results are being finalised and placed one by one in the safe.

With the outstanding results so far of the preCISION platform, CC should sign the one or ones SB/SC/CC have reviewed.

All parties would expect Avacta to sort the wheat from the chaff in this fashion.

Identifying one point in time where all offers are accepted or rejected, means the potential partners have to provide their very best offer if their deal is to be accepted, and they would have spent a lot of time understanding the small print of what Avacta wanted from a partner.

In expectation of the above, I would say the share price will look after itself.

For LTHs underwater for years, I don't feel pressure to raise the sp as a high priority.

-The deal however must be right at or immediately after phase 1b results.

+++

What happens after certain BP with high hopes have been rebuffed is likely to be a journalists dream.

Only if you show subservience to the Donald.

PotUS Trumpus Bumakissemus

What did you learn recently about Narcissism.

This post defines a Narcissistic poster, matelot, get yourself some professional help.

"We’re continuing to have these conversations and we continue the work here deal making at least among several of the players."

Puts me in mind of advice I was given re job hunting.

. Always distribute as many CV's as possible, the aim being to have as many concurrent job offers as possible to provide a choice of opportunities.

When the time comes to make that choice you are wise to the good and not so good parts of each opportunity.

CC et al would be best advised to have as many deals in the safe as possible, so that come decision time, they know exactly what's on the the table.

IMO that should happen as Simon's been so busy.