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Hi Go Sushi
"While optimistic, it is possible that FDA approval could come after the P1b study (i.e., before P2 begins). To be clear, P2 will still be required, but ava6k could be on the market while P2 is being carried out.
Hi JT
You posted the above
I have never read of a DRUG being brought to market after phase one..."
+++
That's as may be.
But because AVA6K is a platform, and Doxorubicin is the well known DRUG in use for 50 years, I can see it being easier for it's approval, because of the relatively inferior performance of pure Doxorubicin.
Dr William Tap declared -
‘if we can come up with a better (treatment), then overnight it could become the standard of care.’
Let all Phase 1 a+b data do the talking (including Biopsies) when the data is complete.
Let's see if it's good enough for FDA approval.
Manufacturing
New Position - Manufacturing Technical Assistant
... "The role will have a particular focus on the introduction of **new products** and technologies into our Production and Quality Management (QMS) Systems, ...."
Key Accountabilities
"...Set up Sage codes and bill of materials for new products, sub-assemblies, and raw materials in the Sage manufacturing system
* Communicate with key stakeholders to ensure their requirements are met in the successful technical transfer of new products and technologies into the Manufacture Team
* Liaise with R&D on any redesigns and improvements as appropriate
* Brief the manufacture team on any design changes and improvements
* Sage administration and maintenance to ensure the system is kept up to date and stock levels are accurate and controlled
Label setup for new products
* Working closely with stakeholders to identify any product cost changes for business as a result of process and product changes
* Working to challenging deadlines as part of an ambitious pipeline of new product launches
* Contribute towards the technical transfer of manufacturing processes to sub-contractors
* Support the wider operations team in supply chain, stores and dispatch to ensure timely product delivery to customer.
+++
If they have got this far, the new products, a decision to put the products into production has been made.
Timster - A good friend sells aircraft simulators for a living.
He used to lead a team of maintainers, but found himself roped in to support when the sales team needed answers to technical questions.
Over a long period of time he now leads the sales teams, as his breadth of knowledge enhanced the sales teams pitch as well as answered potential customers questions.
Dr Simon Bennett joined Avacta on 19.12.23 and had this to say in the RNS announcing his appointment:
"Avacta is at a pivotal point, having recently announced clinical data that have already begun to generate interest from potential commercial partners. I am delighted to be joining at such an exciting point in the journey of the business, to help the team optimise the commercial opportunities of their technologies and assets."
Avacta could do worse than fly out PL to AACR, to provide technical backup in discussions with any and all interested parties.
Https://guoncologynow.com/podcast/episode-305-the-fda-and-oncology-clinical-trials
This one is working for me and my Bourbon poured over ice..
No Apple facilities necessary.
Bella - Because, if it was a while ago, we would know that data for that patient would be well ahead of the third patient. Weeks even a month or two ahead.
Yes they did tell us they would advise third dose. Nothing wrong with comms on that score then.
Did you really mean incestors. - I'm using the right chat board aren't I?
- Targeted therapy that spares healthy tissues is a holy grail of oncology drug development and we believe we have a unique platform to target FAP-rich tumor tissues to DELIVER SIGNIFICANTLY BETTER OUTCOMES FOR PATIENTS AND **SUBSTANTIAL VALUE TO OUR SHAREHOLDERS**.
That's aimed at BP Licensing negotiators who failed to come up to the mark last month. Ha ha!
Thanks chaps
Energy - there was a little more good news on this:
https://www.youtube.com/watch?v=eqj0hhgmX6U&t=1239s
Christina Coghlin Slide 17 (32:34) "The first case to discuss is the young 59 yo gentleman with a soft tissue sarcoma, this is called an Undifferentiated Pleomorphic Sarcoma (UPS). Based on the evidence in the literature this subset of sarcoma is anticipated to have high FAP expression and has a limited response to standard dose Doxorubicin.
What we’ve seen in this particular patient is a deepening tumour response whereby the lesions or the tumours in the various organs in this patient have shrunk by 65% from their baseline, - we do this with CAT scans."
"Various Organs" Plural.
Not seen this link mentioned before on this BB, - so my apologies if posted before.
06.03.2024 https://www.trinitydelta.org/research-notes/successful-31-1m-fundraise-despite-challenging-markets/
Third Bullet Point concerns the possibility of the need for a Phase III trial, but I have not copied here for obvious reasons.
I would assume that Trinitydelta would not release share notes without the content being checked by the company that basically sanctions their activities.
The Trinity Delta View at the bottom of the page discusses Monetising Diagnostics through divestment and the timing of such.
ATBD - "....announcement on 28 February 2024, the Company has successfully placed 51,269,609 Placing Shares at the Offer Price of 50 pence per Placing Share with new and existing investors, including a number of high quality institutions and a European specialist healthcare fund."
That sounds like they are as chuffed with 'a number of high quality institutions' as much as with a 'European specialist healthcare fund'.
I posted this recently, but believe it's relevant to this thread:
RNS - Proposed Fundraise to Progress Therapeutic Division Pipeline - 28.02.2024
"Significant Newsflow
The Company is anticipating the progression of its clinical development and research stage programmes to important value inflection points across 2024 and 2025, which includes key deliverables for the pre|CISION pipeline:
· AVA6000:
o Read out of two-weekly and three-weekly dose escalation study data in late Q2 2024"
If the company 'is anticipating' etc - as above, then at the time these words were written, (28.02.2024) there was nothing untoward in Q3W or any Q2W data.
+++
IMO AACR info has to include Q3W data - cohorts 5,6, & 7, else why bother attending unless you are going to poster info that is publicly available from presentations.
From Question asked at AGM by Wilson in October last year -
" Wilson: There was a £100 million (organic) prediction made over five years. Does that still stand?"
JM - "I don't think that's a sound figure, that figure comes from the end of Q1 2022, I think we were still a £50 million underlying business. At that run-rate we are obviously a long way short of that right now. I think to get there without acquisitions, - it’s just not credible as a number."
+++
Thanks for attending Wilson, specifically with this question.
+++
I'll settle for "It's just not a credible number" - It never was.
Https://h1.co/blog/4-ai-predictions-for-the-life-sciences-sector-by-2025/
The application of AI in the life sciences sector has the potential to revolutionize many aspects of research, development, and patient care. By 2025, we can anticipate pretty significant shifts as AI continues to advance and integrate into various processes within the healthcare ecosystem.
Here are 4 predictions for how life sciences companies might be using AI by then.
Enhanced Clinical Trials and Real-World Data Analysis:
1 Patient Recruitment
2 Post-Market Surveillance
AI-Enhanced Diagnostics and Predictive Healthcare:
3 Image Analysis
4 Drug Repurposing
++++++++++++++++++++++++++++++++
https://h1.co/blog/six-possible-implications-of-bidens-executive-order-on-ai-for-life-sciences/
Six Possible Implications of Biden’s Executive Order on AI for Life Sciences
+++++
Perhaps more than just project Optimus to navigate in the near future then.
I am hoping these changes will not
a slow down our trials
b create extra costs for Avacta.
SB's arrival seems to be the catalyst for the following in the 28.04.2024 RNS.
If so, it's more evidence of his influence, but let's see.
"In light of progress in the clinic with the first of Avacta's pre|CISIONTM tumour targeted chemotherapy AVA6000, the Board has taken the strategic decision to focus resources on its therapeutics drug development programmes as the key value driver of the Group. The Group continues to explore all possible pathways to appropriately finance its clinical therapeutics programmes including divestment of the Diagnostics division in a manner that maximises value for shareholders."
RNS - Proposed Fundraise to Progress Therapeutic Division Pipeline - 28.02.2024
"Significant Newsflow
The Company is anticipating the progression of its clinical development and research stage programmes to important value inflection points across 2024 and 2025, which includes key deliverables for the pre|CISION pipeline:
· AVA6000:
o Read out of two-weekly and three-weekly dose escalation study data in late Q2 2024"
I interpreted this timescale as being early to mid Q3.
because:
a timescales are always stretched after AS calls them.
b 1a data should be ready if not already in public domain after AACR, but
c The start dates of Q2W are too uncertain for results to be nailed to "late Q2 2024"
+++
If the company 'is anticipating etc - as above' then at the time these words were written, there was nothing untoward in Q3W or any Q2W results.
Ans - We are exploring this (everything in the question) but these insights potentially constitute new IP which we need to protect before we can discuss them publicly. We look forward to discussing this in the future.
The question is not answered, but alludes to potential new IP.
Energy finds evidence of new IP.
Looks like your link supplies at least some of the IP Fiona refers to
That was my only point.