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We will only know we are on the tome straight to approval when we hear that a PIVOTAL study has been given approval to proceed. At the moment, Avacta are aiming (aka hoping) for a pivotal Phase 2 study.

They have issued an RNS for:

- approval to start the trial or vary the trial;

- the first patient being dosed for that each iteration of the trial; and

- the completion of each cohort.

The Phase 1a fortnightly dosing will be no different. The first RNS will be about approval to proceed which will include or be shortly followed by news that the first patient has been dosed.

FDA to approve AVA6000 on the market now before Phase 1a (3 weekly and fortnightly dosing) finishes and Phase 2 trial starts?

Just take a minute to consider the implications of that... It totally bypasses all that Alan has said about the next steps: What STS subtype indications? What dosage? What dosing interval?

The whole clinical trial process is there for a reason.

I would expect an RNS to say the fortnightly trial has been approved (if it is approved) and the trial protocol amended, and a second RNS for when the first patient has been dosed.

Let's hope it's not a turkey.

HurstBot gets all the latest gen from his bro, the iRobot Roomba i4 EVO at the Whaler.

No JT, what I stand by is my previously expressed OPINION that Alan hasn't been forthright about the nuances of the situation.

My opinoin is that Alan has not presented a realistic assessment of the situation and I stand by that.

Now, all of a sudden, everyone is changing their opinion on when C7 is due to start based on this new 'not in parallel' assessment of Ambiguity Smith's words despite him agreeing with Paul Hill that it would be 'in parallel'.😂😂😂

I got the impression at the time of the Vox Markets interview that he said that the fortnightly trial would run in parallel with C7 (not at completion), and that was because he definitely agreed that it would be "in parallel":

https://www.voxmarkets.co.uk/articles/q-a-with-avacta-s-ceo-alastair-smith-90b7520/

From 6:46

There is a more important point here. Alan may be able to pull the wool over the eyes of private investors who don't understand how the pharma industry works, but he will NOT be, and from the sluggish SP clearly is NOT, able to pull the wool over the eyes of serious investors, investment houses and pharma companies. Such a pity he can't be honest about the company's intentions are affected by third parties.

I appreciate the humour but I have to disagree Timster as the limiting factor is obvuiously FDA approval. I think it is just another example of the usual slack/ambiguous language from Ambiguity Smith.

From the 19 Sep 2023 RNS: "Therefore, in parallel with the completion of cohort 7, the Company intends to begin a short study to explore more frequent dosing (fortnightly) of AVA6000 as a first line treatment in patients with soft tissue sarcoma. The study is expected to begin in Q4 2023 subject to receipt of approval of a protocol amendment from the US Food & Drug Administration (FDA)."

Or, the brief (real) version: "Therefore, in parallel with the completion of cohort 7, the Company intends to begin a short study to explore more frequent dosing (fortnightly) of AVA6000 subject to receipt of approval of a protocol amendment from the US Food & Drug Administration (FDA)."

One can also reread that RNS para as "... the Company intends to begin a short study to explore more frequent dosing (fortnightly) of AVA6000 which will support use of AVA6000 as a first line treatment in patients with soft tissue sarcoma."😉😂😂😂

Cohort completion RNS dates are:

------- UK sites only -------

C1: 3 Feb 2022 - Thursday

C2: 29 Jun 2022 - Wednesday

C3: 1 Sep 2022 - Thursday

C4: 17 Jan 2023 - Tuesday

---- including US sites ----

C5: 21 Jun 2023 - Wednesday

C6: 19 Sep 2023 - Tuesday

F'in LSE formatting!

So likely a possible RNS tomorrow or from Tuesday next week

Likewise for news of the fortnightly trial being approved by the FDA.

It's going to get very confusing when we start talking about Big AI

Yes, absolutely! Not least because it would be unethical to withdraw an efficacious treatment from someone who has exhausted all lines of standard of care treatment!

JT wrote "As the median number of cycles (at least in C1-C4) received by patients is just 2, my guess (and it's only a guess) is the STS patient with a dramatic reduction in tumour size was from C5, simply because it often takes a few cycles of dox before tumour shrinkage occurs (not always, but often). This opens the possibility of some great case studies coming out of C6 and C7, due to the higher dosage" in the risks to AVA6000 thread and I think he knows his stuff so it's unlikely that a good news story from C7 will have emerged just yet. There may be for a patient from C6 though, hopefully, and more than one would be fantastic news for everyone.

"Imagine your doctor then telling you your tumour is shrinking.

"Imagine starting a new cohort with even more chemo put into your body and still no side effects."

Each cohort starts with a new set of patients and I've got to say that if the first of these were the case, why would the dose need to be increased if the patient continues on AVA6000 post-cohort? Yes, increase if the tumour stops shrinking - the clinician's decision - but increasing the dose whilst the original dose was controlling or shrinking the tumour wouldn't allow the clinicians to determine the long-term characteristics of that original dose for tolerance and effect on the tumour.

So it was all a ruse by long term holders to flush out short term holders and obtain more shares on the cheap. Brilliant! Sujood for PM!

This Thursday. Double celebration. Avacta data and tax cuts for the rich.

Running in parallel was an aim and an intention but not as definite as an expectation.

Hey, it ain't over till the false prophet sizzles.🔥