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Probably just the CEO rebranding the company in her Philadelphia Fillies colours. I would in City colours if I had the chance - it's in the blood.

That said, change is definitely in the air. Dx divestment first , then NASDAQ listing ...IMHO. And the new Avacta brand DOES look Yank.

The blue of authority vs the red of emotional tantrums B2H

They've got a new pot of blue paint

Interesting about the Right to Try law Bella.

This from Wiki: https://en.wikipedia.org/wiki/Right-to-try_law

"In April 2017, oncologist David Gorski wrote in Science-Based Medicine that the right-to-try law is harmful to society as it is popular with the public who do not understand how the FDA works, Gorski calls this "placebo legislation. They make lawmakers feel good, but they do nothing concrete to help actual patients." Gorski states that right-to-try laws enable "cancer quack" like the Burzynski Clinic to operate for years. "It's also important to remember that the real purpose of right-to-try laws is not to help patients, but to neuter the FDA's ability to regulate certain drugs, consistent with the source of this legislation." Gorski further states that these laws "rest on a fantasy... of false hope ... that is rooted in libertarian politics ... that claims that deregulation is the cure for everything."[44]"

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Case in point: More Hospitals Sued Over Right to Try Ivermectin: https://www.medpagetoday.com/special-reports/exclusives/94325

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And this from good old Google AI: https://www.google.com/search?q=right+to+try+law+states

"The Right to Try Act is a nationwide law that allows patients with life-threatening illnesses to access certain experimental drugs without FDA approval. As of May 2023, the following states have passed laws that expand the Right to Try Act:

• Montana: Passed a bill in May 2023 that gives patients access to experimental drugs that have passed Phase I clinical trials

• Arizona: Enacted an expanded version of its right-to-try law in April 2022

"The Right to Try Act allows patients to access experimental drugs if they meet the following criteria:

• They have a life-threatening disease or condition

• They have exhausted all other treatment options

• They are unable to participate in a clinical trial

• The drug has completed a phase I trial

• The drug has an ongoing pivotal trial

• The patient, drug manufacturer, and treating physician all agree to proceed

• The patient provides written informed consent

"The FDA's role in the Right to Try Act is limited to receiving and posting certain information. Manufacturers are required to provide the FDA with an annual report that tracks the number of patients receiving the drug, the number of doses provided, and any serious adverse events.

Some critics of the Right to Try Act are concerned that it prioritizes access over safety. Others are concerned about the equitable balance of individual and public interests."

@Harrogate4, simply that if Avacta is applying for a FDA grant for AVA6000 Phase 1b trial(s), then the application will have gone in by 22 October. We couldn't expect to hear anything about it unless the application were to be granted, and that would likely be near the very end of the year with any announcement about it then or early next year.

The deadline for grant applications for the FDA's Orphan Products Grants Program for financial year 2025 was...

22 October 2024 !!!

Maybe there really is no need to worry about funding this time around...

My new friend has made me see the error of my ways It was indeed the wrong part of the FDA. I meant the FDA's Orphan Products Grants Program:

https://www.fda.gov/industry/grant-programs-support-development-medical-products-rare-diseases/orphan-products-grants-program

A grant from the FDA to assist with the costs, or even completely cover the costs, of Phase 2 would be the cherry on the cake.

https://www.fda.gov/about-fda/doing-business-fda/fda-assistance-grants-opportunities

Spot on bluesy1. Sell 8am and, in your words, move on or, in my words, feck off.

Thanks

Thanks

Thanks. Not sure I see the relevance of ADC lung toxicity to AVA6000's doxorubicin though.

@hanoihank, re "Specifically lung toxicity data, a big problem with many ADC's", could you clarify the context please?

I presume, because of the ADC reference, that CC was talking about AVA6103, not AVA6000?

AVA6103 has not been in humans yet, so was this in mice bearing established HEK-FAP tumors? If so, then the FDA seem to be getting involved at a VERY early, one might say pre-pre-clinical stage, certainly pre-IND-enabling work. And that's what's confusing me.

Phase 1a proved the safety and tolerability of AVA6000 and from it the dose level and frequency of administration for Phase 1b were decided. I don't know whether the same dosing regimen will be used for all three indications (STS, SGC and TNBC).

I can't help with your question about 1st line treatment for TNBC as I personally have not heard anything from Avacta about that but I did see someone write that it would be trialled as 1st and 2nd line treatment.

Does this sort of thing happen to companies listed on AIM?

Big farmer likely to be more influenced by on-site presentations and direct discussions (with SB et al). But would institutional biotech investors be impressed by the slide deck alone? Well I think some parts of it may be obscure without background knowledge but maybe/hopefully SB et al are also in discussions with them as well.

Yes it's missing the final '0'. I think they are calling Arm1C7/Arm2C3 doses the MTD.

The 6-fold increase in MTD was the early study in mice.

What makes it a particularly difficult read for me is that it has a lot of text and it's all in sans-serif text. Serif for large areas of text (it flows for the eye), sans-serif for headers and bullet points (it has impact); that's best practice. If you don't believe me, try a book printed with just sans-serif text!

Maybe Avacta/CC does want to become the next leader in oncology but the many PIs would be pleased with big farmer's back of the sofa money.

Gotta say I found that a very difficult read. Maybe an audio commentary would help? just a suggestion.