Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
From todays RNS:
As previously announced, the Company and its subsidiary Primer Design Ltd are party to litigation with the DHSC.
The trial hearing starts on 10 June 2024, and finishes on 4 July 2024.
The court has listed the Pre-Trial Review to be heard on 30 April 2024. This is part of the normal litigation process and is predominantly concerned with administrative preparations for trial.
The court will also hear an application by the DHSC for summary judgment in relation to one aspect of its claim, as part of which the DHSC is seeking judgment to be entered for the full value of its claim.
***From the previous line it would seem that DHSC is confident that the application for summary judgment, in relation to one aspect of its claim, is strong enough to ensure a successful summary judgment to be entered for the full value of its claim.
This is the DHSC's attempt to avoid a full trial (I assume), and the above does not state that NCYT lawyers will play a part.
It would appear to be DHSC's best shot at convincing the court that NCYT is defending the indefensible, ie this is an open and shut case.
If this were true, NCYT's defence would have been exposed as too weak to hold water in the time since the DHSC claim arose (claim dated 25 April 2022), and now we are preparing for court inside two months, so NCYT defence has not been found 'too weak'.
Time possibly then, for one or other party to capitulate, unless a point or points of English law are at issue, and need to be tested in court.
This would not appear to be the case though.
DHSC are confident and have launched a summary judgement. This would not be in order if English Law interpretation needed to be tested in court.***
Continuing from the RNS:
Having taken legal advice, the Company considers this application to be very weak with low prospects of success, and is confident that the court will dismiss the application.
It is not known when the court will give judgment in relation to the application. It may be during or at the end of the Pre-Trial Review, or a short time thereafter.
RNS ends.
+++
I think if a summary judgement application is denied by the court, that would mean a full trial is to be held as scheduled.
Happy to be corrected on the above.
https://www.which.co.uk/consumer-rights/advice/what-is-alternative-dispute-resolution-adr-alOPl0X2lbsO
Are ADR (Alternative dispute resolution) schemes common?
In the UK, the financial services, energy, telecoms and aviation sectors already have large and well-established ADR schemes.
*Financial Ombudsman Service (FOS) - deals with financial services providers.
*Ombudsman Services: Energy or RECC - deals with energy suppliers.
*Ombudsman Services: Communications - deals with communications providers.
*Parliamentary and Health Service Ombudsman - deals with NHS organisations and government departments and services. - So I assume this is who has performed the ADR function.
Wyndham 11.40 today
"Thats a little disingenuous gje, his (Bellamy) analysis has been based on the results. And he has(and still has), quite a few supporters here who have appreciated his "papers" on AVCT over the YEARS"
Bellamy a member since 18.01.24 though..
Makes you wonder exactly how long this pair have been deramping.
JW has selected LR for CEO for his abilities to sell, find and develop prospects.
He knows pretty much more than anyone about Yourgene products.
However the financial situation that lead to Yourgene joining the Novacyt group IMO has led to JM giving the new CFO the brief to monitor closely LR's projects, to keep LR in budget.
Technically JW has no problem with LR.
Financially he doesn't want a repeat sp crash, hence SG's involvement.
That seems reasonable in the circumstances.
Yes. Aware of consequence BV
Re 'further valuable long-term data for that 160 migs dose level would not be possible.'
Long term data is available and will continue to be available, should he agree to continue on treatment past the end of the trial for which he was a voluntary patient.
So he could stop his participation (participate in other trials, undergo surgery etc), as he has completed what he agreed to - phase 1a.
Dose / Frequency as per trial cohort 3 and scans currently continue as agreed between Avacta and patient.
Voluntary Biopsies.
Although CC mentioned in the Investor Meet presentation Dec 13th:
"....However, given the limited exposure that we’ve seen in the bloodstream in this patient and others at this dose level of 160 migs, we are going to be able to dose this patient a further seven additional cycles if his tumour doesn’t progress and this represents up to another five months of therapy which would bring him up to a total of fifteen months on AVA 6000.
This represents three times the length of time that this patient could be treated if he was receiving standard dose Doxorubicin.
Correlative studies also indicate that tumour biopsy in this patient has high FAP expression", - we don't know how many Biopsy's he's provided.
He agreed to that trial without the knowledge that frequency of dose would increase, and he only has some of his Doxorubicin exposure allowance left. - What to do with it?
Assuming he has sufficient lifetime limit available, he might decide that the 2 week dose schedule would be preferable, accept the consequence of that decision, and make that request.
Because post phase 1a, he is now his own health decision maker, who currently decides to continue as he has so far.
Whether that request might be allowed, is for clinicians / SDMC to decide, but it would be his health at stake.
I take your point that he is still responding to treatment whilst his lifetime limit approaches, but why wouldn't he want the team's point of view of a program which included 960 migs over 12 weeks, ie 160 migs every 2 weeks + scans and perhaps voluntary biopsy(s).
In his situation the concern might be he won't be making as much progress dosed three weekly, as being dosed on a two weekly regime.
I remake the point that he has the option to no longer volunteer on present regime.
He might opt to request a 2 weekly delivery schedule.
When he signed up to receive AVA6000 in phase 1a at cohort 3, there would not have been any mention of arrangements after phase 1a finished, otther than a phase 1b was planned.
Because he has lived beyond the end of phase 1a, and continues to receive AVA6000 at the same frequency and dose, all know that he is much further down the road to lifetime limit, but not there yet.
I make the case that he has deserved consideration to move to a two weekly dose, or for that matter a different dose if CC etc deem that possible or advantageous to him, because of his tremendous contribution to the phase 1a trial, - all he originally signed up for.
So because the lifetime limit is now a consideration, and when he started the trial it was not, his circumstance has changed, and we have now developed the 2 weekly dose Arm 2.
If he has sufficient Doxorubicin exposure left to merit that consideration, and it is deemed suitable for him, then that is what we should do about his new situation.
I take your points that the tumour size reduction is not as small as first posted, but life time limit as you see is my concern, and further assistance for this patient should be a consideration.
+++
Bella "what about those itsy bitsy cancer cells that may have been undetected by the scans yet lurking and growing undetected"
If they generate a high FAP environment then AVA6000 should be reducing them as has happened to his other tumours.
Have the itsy bitsy cancer cells that were not detected shrunk to nothing?
His cancer had metastasised, that's all we know, but we can surmise that any tiny cancer cells are now gone perhaps.
Thanks Thompi, - I'd thought along similar lines.
I just think he's done everything to provide data for phase 1A and more.
Now it's time to think of his final state of health after their are possibly no more AVA6000 doses, and he still has cancer.
I know, nobody promised him a cure.
Tough decisions for all ahead.
Turner Pope Investor Webinar 10.04.24 contains :
"The patient with the first partial response, a patient with Undifferentiated Pleomorphic Sarcoma had their first baseline scan in February 2023 last year, that's when he started on the trial, and the latest follow up scan was in January 2024.
The patient is still on trial with a reduction in tumour size of 74% (as of January 2024)."
I could understand this patient, who must be due a scan shortly, must be feeling great to be alive, but possibly nonplussed to find the reduction in his tumour diameters were from 65% to only 74%.
Phase 1A is complete, the data collected, and those still alive are receiving AVA6000 at their cohort level.
He is receiving AVA6000 at cohort 3, 160 migs every 3 weeks.
If I were him I would have made representations to change present dose frequency to every two weeks.
He could argue his response to AVA600 is stalling, and as he's been on drug since Feb 2023.
He must view Arm 2 as being his chance to improve his health faster, before his situation reaches the point where he is unable to receive further AVA6000 with his tumours still present.
It has been great to use him as a data source for the 3 weekly study for so long, but I believe he should be given AVA6000 on the two weekly study at present dosage, such that his 12 weekly cumulative dose increases from 640 migs to 960 migs,m after which time he must be close to the maximum lifetime Doxorubicin dose.
Perhaps a decision might be made after his next scan.
So on the basis that if you laughing your not crying -
Lets plan the Dx profitability party, we're not talking just Champers here. 😁😢🤦♂️✨
Somewhere mid-UK, - or do I mean a whisky distillery - Scottish West coast.
Sod it, Tahiti it is then.
Making the assumption that the DHSC claim is rejected and,
Novacyt becomes a cash cow target overnight with takeover rumours abounding.
There must be companies who think they can produce far better plans than JW / JM have so far.
How long after the court case do we have to wait for a bid?
Hold on though, - JW has his own plans for the cash bundle he's waited so long for, - and he doesn't do dividends.
Which fire sale company is the Novacyt group contemplating reversing into next, - and at the speed of sound or light?
Yes!, Lyn Rees does takeovers, it's on his CV.
Come to that, - SG is good with money management!
Same helter-skelter journey that GM used to do when he was boss,
but the G-forces now have to be experienced to be believed.
If you don't laugh you'll probably cry.
'The new head of R&D is Gem Mcluckie' - I was discussing Novacyts Southampton based R&D team.
Paul Oladimeji described himself as head of R&D on linkedin between Jan 2021 and Jan 2024, beside a Novacyt logo, so Head of R&D Novacyt.
From past notes he has described himself as 'Group Head of Research and Development at Novacyt Group', - (meaning Microgen and Lab21 I believe). However, that was before Yourgene became part of the Novacyt group in Sept 2023.
Gem McLuckie has a Primerdesign logo beside her head of R&D title on linkedin, when her previous jobs in the company display a Novacyt logo beside them. That may be to differentiate herself from head or R&D Yourgene.
We need to know the head of Yourgene R&D to see whether Gem is head of Primerdesign only, which I have never researched.
Apologies for any confusion.
WBAFC
Paul Oladimeji was head of R&D when he left the company in March.
The new head of R&D is Gem Mcluckie, appointed Nov 2023 - according to Linkedin.
She has a good set of skills available to her in this department .
Dr Joanne Mason, the Company's Chief Scientific Officer, will join the Novacyt Board as an Executive Director
effective from 1 May 2024.
Gmcc
From Ophidians post, why will BP not make plans to acquire this platform.
NCYT have full access to the preCISION IP.
As CC said in the 09.04.2024 RNS "particularly the tumor-specificity of the release of doxorubicin through targeting FAP and simplicity of the manufacturing process which results in significant savings in the cost of goods."
ADC manufacture is tricky.
IMO Avacta's future may not be very long after a successful Q2W.
AS has hired SB & SC.
AS should have a more pro-active CFO available to assist him as a technical man operating as CEO.
If they can't agree as a team, replacements are needed, but that's difficult when one is the founder,
and it's early days for this team.
I'll go with replace the CFO, but equally the founder needs to be listening to his fresh advisors.
There are signs of that with Dx being made ready for sale.