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Thanks Dogs80. I'd skipped over that. So nothing divulged by Alan that can't be told to the market before it opens on Monday.

Was the response after markets closed? I asked gmcc but no answer as yet. Maybe someone who hasn't been filtered could ask? I think that if it was after 4:30 (and he could have responded at any time after gmcc's email was sent on Wednesday), then we are very close to getting an RNS related to DE4/C5 and, as he'll know that his responses to both emails are likely to fire up PIs, my guess is an RNS at 7am on Monday.

- Waiting on new Phase 1a and 1b protocol approval by MHRA, FDA and possibly EMA if European investigator site(s) are not Swiss. If the European investigator site(s) are just in Switzerland then it could possibly all be dealt with by Orbis.
https://www.gov.uk/guidance/guidance-on-project-orbis

- Waiting on resource allocation by the proposed 20 investigator sites (previously 8 had been lined up).

- Waiting on finalisation of the FDA's Accelerated |Approvals guidelines on trial design.

- Waiting for all their ducks to be aligned.

gmcc has always struck me as a genuine and serious, humourless even, contributor so I tend to believe that this response from Alan is genuine rather than a spoof.

When did you receive this response, day and time, gmcc?

Filtering all the non-serious people (bashers, traders, paid trolls, rampers, fantasists and the arrogant and potty mouthed), leaving just those that bring something useful to the table - information, interpretation and/or insight - actually makes this board a very good and much briefer read!

If you think that VR then surely you've sold, so what are you doing hanging around this board like a bad smell?

Anyone who thinks VR is a serious person, rather than a trader or paid troll, is a fool.

LLP makes a very good point. The underlying tech comes from Tufts (now many years in development) and Leeds Uni (no major deals, or deals with majors such as Aptamer has achieved). Commercialisation is sloooooooooooow.

Fyi Bigears, that text was not changed before SD. It is old text. Been around for ages. Which frankly doesn't bode well re good comms.

Fyi Icecool, it was stated at SD, as it had been in the 17 Jan RNS, that C4 had completed. Each cohort starts with new patients.

This news blackout is totally unacceptable . Can't help but think we're being set up for a cheap buyout that Alan is doing nothing to counter as it's been agreed and he knows what he'll be getting, compensation-wise and role within the new organisation.

Someone wrote that they'd accept £2.50. Well not if the SP were at where it should be, £2 or so, they wouldn't. But people are so fed with the SP being manupulated in this crooked market to the benefit of IIs that they're becoming glad to get the chance to be out. After this, certainly no more AIM investing for me.

@54retiresoon, because the FDA will require proof - and Avacta will also require proof to make AVA6000 the standard of care.

Slide 87 from Science Day sets out what the strategy is*. Next will be breast and ovarian cancer and a single quick comparator trial for both indications against standard of care doxorubicin should settle that. Then with AVA6000 approved for those two indications the cash would really start to roll in and trials for all the other cancers where, because of toxicity, doxorubicin is not the standard of care could begin. These trials would be more complex and longer as they wouldn't be prodoxorubicin vs doxorubicin but (pro)doxorubicin vs drugs that have diffeent modes of action.

* As we saw in Dr Tap's slides, STS is not a single indication but many (over 100 I think he said) different ones. The same holds for other cancer types I should think. Whether this makes a difference for AVA6000, as long as FAP is present, would be something for clinical trials to find out. Different cancer types with typically different levels of FAP may require different dosing regimens for instance in order to achieve maximum efficacy. But to start with, a straight swap of AVA6000 for doxorubicin is an easy start and the dosing regimen can be split and optimised for individual cancer types at a later date (which would require additional trials to prove improved efficacy).

I'm surprised you don't also want to know the dimensions, weight, what materials it is made of and what colours it comes in boffin. Are you asking for a competitor?

Provide a link to what you thought then garmoan and prove your point.
You can't. There isn't one. You're a liar.

"new product release but no orders"

That's not scraping the bottom of the barrel of deceit, that's scraping the skin off your hand scraping the bottom of the barrel of deceit.
Give up loser.

@StarBright, take a look here.
https://www.royalmarsden.nhs.uk/about-royal-marsden/our-research/clinical-trials/what-types-clinical-trial-are-there

AVA6000 is a lot more valuable than the usual anticancer drug candidates for these reasons:

The active, doxorubicin, is a proven and well characterised drug. If it had be shown that AVA6000 releases doxorubicin in FAP-rich TMEs (tick) and efficacy can be shown, then it's nailed on for being approved - and with a huge TAM.

The Phase 1b, as put forward at Science Day, will compare two different doses of AVA6000 against the (largest) standard dose of doxorubicin of 75mg/m². This is not your normal Phase 1b dose expansion study by any means! It has a large element of a Phase 3 trial, albeit a very small one, in that AVA6000 will be compared against the standard of care for STS. So it is really set up as a dose selecting AND proof of efficacy study, and if AVA6000 is shown to be at least as effective as doxorubicin (considering efficacy and side-effects) at the end of the doxorubicin 18 week course then I wouldn't be at all surprised to see AVA6000 being submitted for approval as the trial continues with the two AVA6000 arms. If clear superiority is shown before the end of the doxorubicin course then I'd expect patients in that arm to be switched to AVA6000 on ethical grounds.

That withpower site is seriously sh ite.

Time to load up at these prices. It would be rude not to.

That would be interesting!
A rainbow-chasing gambler's view of Avacta. Research time: 5 minutes.

If you can't program your bot to add to its existing threads, please at least give it the ability to create more interesting and, dare I say it, informative thread titles than just 'Trading' or 'FDA' five times a day.

Suggestions

Howdy folks, listen up
Well I never...
Someday
F**k me, this is news
Y'all never believe this y'all but...
Tie me to a tree and call me Alice
When I was walkin' down the street
A new development in biotech

Mine's a one-way ticket to Paradise please HurstBot.

AVA6000 not included as of 1 March 2023

List of products granted eligibility to PRIME (XLSX/116.08 KB) (updated)
https://www.ema.europa.eu/documents/report/list-products-granted-eligibility-prime_en-0.xlsx

First published: 19/10/2016
Last updated: 01/03/2023
EMA/521657/2016

Well, there's an interesting possibility for finding MTD quickly:

Dose the first patient at 240mg/m² and if the data continues to be as predicted (i.e. consistent), dose the next patient at 280mg/m² and so on. Six patients would take the dose level to 440mg/m² which would be 297mg/m² of doxorubicin, or 5 times the standard 60mg/m² dose or 4 times the standard 75mg/m² dose. Stop any time when there is a treatment-related DLT, or whatever the criterion for halting escalation is called, and do more thorough multi-patient fine-tuning dosing in a new 'cohort' just below that level, e.g. from 320mg/m² in 10mg/m² or 20mg/m² steps if the toxicity appeared at 360mg/m².

Would absolutely require authorisation from whichever regulatory authority was overseeing the trial (just MHRA if in the UK only) as no one, clinician or Avacta scientists, would risk reputationand everything that follows from that should such a scheme go wrong. No wonder he couched it as "talking hypothetically".