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The only certainty is that no certainty can be inferred from the non-arrival yet of a new CFO.

The fact is that getting AVA6000 and the other pre|CISION compounds to market will take as long as it takes, meaning as long as it takes to satisfy the regulatory authorities that they are safe and efficacious. We now have experienced pharma executives, professionals who've done this sort of thing before, heading the company.

The fact also is that wyndrum, thornogson/NDN/eggy and toukankahmoon are traders and/or damaged individuals who are ignorant of the processes involved in clinical development as well as the underlying oncology and can, indeed should, be disregarded, filtered or reported when they spout their disinformation to try to influence sentiment (their FUD).

...And the willfully ignorant troll has clearly never read beyond "AffDC".

What he was saying there had nothing to do with Avacta.

@PLS, he's been doing these interviews since before his hair turned grey. https://www.alainelkanninterviews.com/?s=virgilio

Great find benton!

I particularly liked this: "But with this special Avacta technology we target the cancer environment rather than the cancer cells...."

"we" WE! First-hand experience reported by a top oncologist.

I didn't know what FPI meant either but found it in a slide footnote. It means First Patient In.

It is 'recommended dose for expansion'.

It is the dosing regimen (dose level and frequency) that is agreed between the company (Avacta) and the regulatory authority/ies (FDA, MHRA?) that will approve the dose expansion (Phase 1b) study.

TNBC certainly were included. A cohort isn't a fixed group, it is a cut through the population. So if the RDE used a Phase 1a dosing regimen, the TNBC patients could be included in that Phase 1a cohort as well as being their own RDE cohort along with RDE cohorts for the other two indications. My point was the RDE cohort(s) were likely not a vast amount of extra work - TNBC patients certainly, and probably a number of additional STS and SGC patients up to a completely new set of STS and SGC patients if the RDE does not correspond to an existing Phase 1a cohort.

Well yes, the use of cohort/cohorts depends on the audience and the granularity desired.

For us plebs and the market, cohort has meant all patients having the same dosing regimen. For the audience for that corporate presentation the patients on that dosing regimen were split into cohorts with the same cancer type.

If the dosing regimen for the RDE corresponds to an existing Phase 1a cohort then, if they needed more patients with STS and SGC, they would have backfilled that cohort as well as recruiting the TNBC patients. We're then into semantics about what a cohort is - what we can regard as a paradigm shift from a cohort being patients with the same dosing regimen to a cohort being patients with the same cancer type.

There will be no running commentary on how the Dx sale and licence/partnership negotiations are progressing. News will come out of the blue. We can only hope that we will get transformative news.

RDE cohort, singular.

No way has Avacta had time to carry out more than one cohort, assess the data, present the data to the FDA (and MHRA?) and obtain approval for Phase 1b from the regulatory authorities.

Thursday's RNS:

"...today announces the completion of the enrollment in the AVA6000 Phase 1a Dose Escalation and Recommended Dose for Expansion (RDE) cohort..."

"Updated data for the Phase 1 dose escalation cohorts and the recommended dose for expansion cohort will be presente..."

"...anti-tumor activity observed in the Phase 1 dose escalation and RDE cohorts of the trial..."

The RDE cohort was either using an existing dosing regimen but just for TNBC (or mainly for if they wanted more data for the other two indications) or using a new dosing regimen for all three indications.

Phase 1b will be no more expensive for TBNC than for the other two indications. Phase 1b for AVA6000 will be to prove efficacy as well as providing more data on safety, side-effects and long-term tolerability. In this respect Avacta, with all those long-running Phase 1a cohorts providing lots of data already, is well ahead of the game with AVA6000.

Phase 2 will be about proving that AVA6000 is better than existing therapies. For the other two indications that's very simple as there are no existing therapies other than doxorubicin for STS but for TNBC there are many therapies on the market and many, many combinations of them. That is why it would be too expensive for Avacta to go it alone with AVA6000 for TNBC.

@LLP, yes, as far as I remember or have found lodged away amongst the many presentations, breast cancer patients had not been specifically mentioned in Arm 1 or Arm 2 (Arm 1 taking a wide selection of FAP-rich cancers, Arm 2 more targetted to what would be the Phase 1b cancers).

And yes, I'm sure the FDA would have required data about TNBC for AVA6000 to be given to TNBC patients in Phase 1b, and that such data would need to have shown efficacy, hence the RDE cohort, which may also have included the other two indications if more data or confimatory data was required by a skeptical/amazed FDA. It may seem obvious that efficacy would be shown but it is important to prove each step as AVA6000 jumps through the hoops.

Did your parents not teach you about the birds and the bees? Five minutes at the most after the pen is out.

Traders such as GeneralOz and Bottomsup only arrive and start with their FUD because they want to buy in cheaper and, despite the doom and gloom they spread, they think the share price will recover. That's the only reason they are here - to buy lower so that they can sell higher. They wouldn't be here if they thought the Avacta SP was on a relentless downhill slide would they.

Licence deals are like pregnancies. Simon keeps on networking and negotiating, and then one day...

@icecool, the was only one RDE cohort, not "multiple new cohorts".

Hopefully that someone is doing well on the trial Pharma3

The RDE cohort should also allay any queries the FDA have about efficacy! https://tinyurl.com/58cnavuj

So far as I can fathom there have been no TNBC patients on the trial in Arms 1 or 2, so if there was a separate TNBC RDE cohort then either the whole RDE cohort would have been just for TNBC patients or they would have been using a different dosing regimen for TNBC from the other indications - if all three indications are to have the same dosing regimen, then that would be a single RDE cohort and they separate out the efficacy in the trial analysis.