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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".

Well they reached where they were intending to get...

"We are now in a position to proceed beyond the fourth cohort in the dose escalation study to even higher doses than originally anticipated, which is an unexpected and very positive development."

...so they could have published data then.

That "unexpected" suggests that the SDMC's decision that the trial could continue took Alan by surprise and hence the delay is the continuation of the trial being organised, probably with the research centres involved as they wouldn't have planned resources for it, but also with the regulatory authorities if, as we think, Avacta are planning to change the trial protocol for Phase 1a ahead of a rejigged Phase 1b.

Andrew, sorry. Dr Andrew Saunders

Dr Andrea Saunders @1:33:47 "We've enrolled 19 patients to date" and of course there are no C5 details of dose or patients on the slide.

So C5 had not started by 23 February.

It may not be Wall Street but it is the AIM casino. Time to repost this salutary advice!

https://www.griproom.com/fun/10-signs-your-company-is-about-to-be-acquired

Shhh! CJ, VR is an expert pharma analyst, dontcha know. Just look at all the wisdom in his posting history.

Fantastic news for Avacta's gene therapy programme!

In other news:

I met a doctor in the park yesterday who told me that AVA6000 will soon be available in oral form from supermarkets in 6000ml bottles in the fizzy drinks section. Quack Quack

I would have thought a change to the trial design as set out on SD was major news though...

Going from dose expansion in 1 to 3 indications to two arms with different AVA6000 dose levels AND one to compare against doxorubicin, the standard of care for STS. Come on! THAT is no longer Phase 1, that is major news.

Of course major pharma with their hundreds of trials doesn't inform the market every time there is a dose escalation or a little bit of news about this or that. Doesn't mean Avacta won't.

JT, I don't think the figures given for doxorubicin levels in tumour and plasma are, in themselves, particularly useful. You touched on some reasons - how the levels change over time and comparison with doxorubicin itself. What is missing is the PK that will show how the levels of AVA6000, doxorubicin and the doxorubicin metabolites (doxorubicinol, etc, etc) change over time and will give the picture of the flow of these through the body.

What I also felt was missing from the AVA6000 presentation was tying biopsy data to tumour type, except for C4 where all tumours were CRC but the biopsies there were from liver or lung, so questions are: Would similar levels be expected in liver and lung? Are liver and lung each ****geneous as regards doxorubicin levels or is there a gradient of concrenrtration away from the site of cleavage/blood supply giving different readings for different locations? - And if so, how proximal/distal to the sites of cleavage/blood supply were the biopsies taken? - I..e. can a single biopsy be statistically sound? Also, are there causes of natural variations in concentrations between individuals?

A lot more data needs to come out I feel before the results, as presented, can be properly evaluated.

Yes, reappears with every new page. F'in annoying on the mobile. Firefox ad-blocker not suppressing it on either mobile or PC.

us PIs

I agree a trial status update would be appreciated by is Paid but any associated SP rise would just get sold into by Heights. Only a clear view to revenue will cause a step change in the SP.

You've got to look at it as the market does not as a well-researched PI digging below the surface. Avacta has given the market nothing this year except news that the trial, which has completed 4 cohorts in 18 months, will complete another 2 cohorts in 6 months. And that from a CEO who has repeatedly fallen short of meeting his own deadlines, quite apart from the covid LFT fiasco and complete lack of any news about new LFTs in the year since.

Maybe IIs are buying in small amounts at these knockdownp prices. Difficult to see how they could get a lower price on a risk-benefit calculation given what they heard on SD but maybe their risk checks and balances don't allow than to do that even.

Without any news that will truly convince the market to dive in, such as a clear sight of future income, any rise in the SP will just be sold into by Heights' loan repayment shares for the next four and a half years. There has been no news since 17th January and the trial with the one pipeline drug is stuck in limbo with the unlikely target of reaching its next milestone by mid year. What is there for the market to get excited about?

Amazing that there are still people who haven't filtered the windbag.

lol

'AVA3996 data poster presentation at AACR' near the end of the month, followed shortly by 'Notice of Results and Investor Presentation'.

OK, I stole that from last year.

Preliminary Results last year were on 6 April. If it is held in person this year then there will be an opportunuty to ask questions about all those topics you list RMFatGB. If purely an online presentation again then no chance. We know already that when questions have to be lodged, the ones that are important to us get dodged, even in the list of Q&A posted later. But, mind you, with Avacta's committment to "[c]lear communication of our corporate objectives and keeping our shareholders up to date with progress" still emblazoned in red on the website, maybe it would be different this time?... OK, no, no one expects that.

Best to keep politics well away from clinical decisions for obvious reasons.

Frameworks for orphan drugs, breakthrough and fast-tracking are enough, together with tax rebates for R&D spend.