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1st Cohort completion
RNS Thursday 3rd March 2022
2nd Cohort completion
RNS Wednesday 29th June 2022
3rd Cohort completion
RNS Thursday 1st Sep 2022
4th Cohort completion
RNS Tuesday 17th Jan 2023
5th Cohort starts
RNS Wednesday 5th April 2023
First patient dosed USA
5th Cohort
RNS Thursday 27th April 2023
5th Cohort completion
RNS Wednesday 21st June 2023
6th Cohort completion
RNS Tuesday 19th September 2023
So as BV said RNS could land midweek Tue,Wed or Thursday depending when safety committee meets but 7th Cohort is the last they don’t need safety committee just waiting on QC now so Monday’s and Friday’s are in play.
Tik Tok we have to wait ….
71 days of C7
385mg (260mg)of Dox and trial continues….
Relaxed and chilled waiting for the data to drop…
GLA
Just found this made me laugh….
https://bingobaker.com/view/5607738
I asked question a few months back and was told they have long gone.
Myles doesn’t think so
A blast most definitely from the present.
My understanding is that Richard Hughes hasn't sold a single share since buying in in the 18p placing, back in April 2020 (along with Mahmud Kamani); and has actually only added in subsequent placings.
He is a major supporter of #AVCT.
3 years of filling ISA’s
Tik follow Tok
It’s coming GLA
https://m.youtube.com/watch?v=Y9znA_dwjHw&pp=ygUPZ3Vpbm5lc3MgdGlrdG9r
I seen it , well I thought I did but it was the Mrs throwing some tin foil into the wheelie bin.
Interesting link that shows what Ava6000 trial PK data would be going through at the moment.
Protocol Registration Quality Control (QC) review process
https://prsinfo.clinicaltrials.gov/ProtocolDetailedReviewItems.pdf
The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.
LARTRUVO's indication was approved under Accelerated Approval, and is based on data from the Phase 2 portion of the pivotal JGDG trial.
Vaccines were approved in 10 months for covid .
Avacta have 2.5 years data
BITL
I just googled “ does a protocol amendment from the us food & drug administration fda“
Question is there from the link I posted
I think a lot more going on with FDA than we all know:
I got a hunch next RNS is approval while P2 moves forward.
If it working and shrinking tumours for these patients FDA will want this on the market ASAP. Avacta will need to partner with a BP to achieve this.
Has the 2 week study started:
From C6 completion RNS:
The excellent safety profile of AVA6000 should allow more frequent and/or higher dosing compared with the standard doxorubicin regimen which could in turn improve the outcome for patients.
“Therefore, in parallel with the completion of cohort 7, the Company intends to begin a short study to explore more frequent dosing (fortnightly) of AVA6000 as a first line treatment in patients with soft tissue sarcoma. The study is expected to begin in Q4 2023 subject to receipt of approval of a protocol amendment from the US Food & Drug Administration (FDA).”
Now look at this:
Do protocol amendments require FDA approval?
FDA does not issue “permissions” or “approvals” for protocol amendments, your changes are effective immediately upon the receipt of your amendment by the FDA.
The IRB may request documentation of FDA review of amendments and may hold approval until documentation is received from the FDA.
https://ssri.psu.edu/clinicalresearchguidebook/reporting-new-information-fda-and-sponsor#:~:text=FDA%20does%20not%20issue%20%E2%80%9Cpermissions,is%20received%20from%20the%20FDA.
My take, fortnightly dosing is taken place now along side C7 if IRB have not requested documentation.
Avacta don’t need to RNS fortnightly dosing they did that in last RNS.
If the sixth dose cohort at 310 mg/m2, which is equivalent to 2.7 times the standard dose of doxorubicin has shown a significant reduction in tumour volume.
Then what will 385 mg/m2, which is equivalent to approximately 3.5 times the standard dose of doxorubicin be doing to these tumours….
Roll on the next RNS…
GLA
Imagine being told you have months to live and offered the chance to take part in a new trial that will put more chemo and less side effects into your body to make your last few months more tolerable.
Image walking into one of the best cancer clinics in the world in MSK on your first day in clinic and meeting other patients in the same position as you.
Imagine just a few months later you have no side effects and your doctor tells you the cancer has stopped growing.
Imagine your doctor then telling you your tumour is shrinking.
Imagine starting a new cohort with even more chemo put into your body and still no side effects.
Imagine seeing the other patients you started your chemo with in April and all of them are still alive.
Imagine your family and friends looking forward to Christmas with you,when you thought you would have passed by now.
Imagine what the reaction will be when your trial data goes public.
Coming soon well done Avacta
Never mind….
Anyone know when it’s Telegram day
Just in case my alarm doesn’t go off
Happy Sujood day tomorrow everyone….
😜
Roll on Data Avacta could end up with a very valuable platform.
Platform technology provides a better, more cost-effective way forward.
The new paradigm in drug development: Why platform technology is the solution patients and payers need.
https://medcitynews.com/2022/05/the-new-paradigm-in-drug-development-why-platform-technology-is-the-solution-patients-and-payers-need/
I rritable
G rotesque
N oise
O dd
R epetitive
E xcruciating
12 trading days left in November
For full impact on media Avacta shouldn’t release data on these dates:
Inflation figures 15th Nov
Autumn Budget 22nd Nov
Black Friday 24th Nov
So if not this week
Doesn’t look likely next week
So my guess last week in November W/C 27th Nov
Come Avacta Welease Wodger
GLA…
Dr Eliot Forster, Chairman of Avacta Group plc added:
"Targeting of cancer therapies to tumour tissue has been a long sought after goal for many oncology drug companies, clinicians and patients. There are many potent anti-cancer drugs, the effectiveness of which is limited by the systemic toxicities and lack of tolerability for patients.
Well the many will start knocking soon….
“Avacta couldn’t spell it out any clearer, but still the trolls keep trying to spin negativity”
Why put “Revolutionising
the treatability of solid tumours” on a massive screen outside your office
If it didn’t work ?
Why does CEO state in a RNS
“One patient with soft tissue sarcoma has shown a significant reduction in tumour volume in response to the drug”
If it didn’t work ?
Why does CEO states in a RNS
"I believe that we are on the verge of a paradigm shift in how chemotherapy is delivered to cancer patients.”
If it didn’t work?
Why does the CEO answer when asked about future funding :
“don’t you worry about that”
If it didn’t work ?
Why does the Consultant Chief Medical Officer state in a RNS
"We have potential to exploit AVA6000 to treat other cancers such as breast and ovarian and a wealth of opportunities to build our pipeline and partnerships.
If it didn’t work ?
Why does the Chairman of Avacta Group states in a RNS
"The clinical data emerging for our lead pre|CISIONTM drug, AVA6000, is ground-breaking. We are seeing a dramatic reduction in the usual toxicities associated with anthracycline chemotherapy and we have clear indications that doxorubicin is being released in active form in the tumour microenvironment.”
If it didn’t work ?
Why did Shaun Chilton join the board as Non-Executive Director
If it didn’t work ?
Why did Dr William Tap choose to work with a tiny Aim Biotech in Avacta and not accept larger rewards from BP
If it didn’t work ?
Why have the MHRA & FDA approved 7 cohorts with potential fatal doses of Dox
If it didn’t work ?
Why have Avacta concluded that a phase 1B is no longer required and will move straight to phase 2 and is on record as saying it works…
If it didn’t work ?
Avacta couldn’t spell it out any clearer, but still the trolls keep trying to spin negativity.
Hold on to your shares and wait for PK data for your rewards ….. GLA
This is why Avacta’s Pre/Cision platforms PK data will be on every BP board room table in the very near future.
AS and the Avacta board have played a blinder with timing of AVA6000.
According to Precedence Research, the global oncology market size worth at US$ 203.42 billion in 2022 and is predicted to reach over US$ 470.61 billion by 2032.
GLOBOCAN, has stated that approximately 19.3 million new cancer cases and about 10 million deaths related to cancer were recorded in 2020, across the globe. The IARC has estimated that the new cancer cases are expected to rise by 47% all over the globe from 2020 to 2040.
North America accounted for around 46% of the market share in 2022 and dominated the global oncology market.
https://www.precedenceresearch.com/oncology-market