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The actual words Al used are at 11:30 - the spacer can affect the rate at which drugs are released

Hi Bella & BV, this was when Al reached on about slide 13 (lucky for some?) and it’s what he was saying could be added to the formulation - it wasn’t being used with AVA6000 but I took it this could be added in.

The other point I noticed is when he talked about the mechanism of the Pre|CISION platform he mentioned they could also include a ‘spacer’ that could control the release of the active drug into the tumour environment. So I see this as potentially much higher doses allowable that would target the cancer by slow release of therapy at the MTD 🧐 without need to return for repeat injections?

Love the positivity Penstock but have to agree with Corryvreckan1 that this is “not a good look when they have had 6 months to prepare them and stated they were to be expected today just 2 weeks ago”.

An RNS could drop at any time. Particularly if they are in discussions with any big Pharma companies to be ready to scale up production of AVA6000. If shareholders are weary of the price not reflecting the results they might well be tempted to accept a (relatively low ball offer at 2/3 x the current share price.

e.g. “ THIS IS AN ANNOUNCEMENT UNDER RULE 2.4 OF THE CITY CODE ON TAKEOVERS AND MERGERS (THE "CODE") AND IS NOT AN ANNOUNCEMENT OF A FIRM INTENTION TO MAKE AN OFFER UNDER RULE 2.7 OF THE CODE. THERE CAN BE NO CERTAINTY THAT AN OFFER WILL BE MADE, NOR AS TO THE TERMS ON WHICH ANY OFFER MIGHT BE MADE”?

While we wait for the rest of the market to catch up it’s simply a good opportunity to add a few more (which is what I’ve done this morning). GLA

Timster It will be interesting to see how they answer that question (what are avacta's plans to scale up production when AVA6000 replaces dox for standard of care). I’ve already submitted my questions to do with plans for AA if the parallel study demonstrates any repeats of the reduction in STS tumour size.

A G Bell ok

Muck165 totally agree that this seems to be exactly why the company is going down this route.

As cohort 6 took from April to Sept with 3 weekly dosing and the parallel study using AVA6000 for STS will be using a two weekly cycle the study will most likely conclude within Q4.

If this study provides results that show tumour shrinkage and/or other clear clinical benefits (tolerability & decrease in negative side effects) then this is exactly what is described as being required for Accelerated Approval to be granted by the FDA see Project Confirm -

Q: Are specific endpoints used to support accelerated approval in oncology? Are these different from the endpoints used to support traditional approvals?

A: In oncology, accelerated approval has frequently relied on the endpoint known as overall response rate (ORR), which is a measure of whether tumors shrink or are eradicated after treatment.

https://www.fda.gov/about-fda/oncology-center-excellence/project-confirm

Yes I could see them not being able to scale up production fast enough given that each patient would be on much higher doses and more frequent cycles with an unknown extended lifetime cumulative amounts.

This is probably why one of the big pharmacy company’s who currently produce doxorubicin would offer to step in and make an partnership offer but given the number of company’s currently producing doxorubicin Avacta would be in a very strong negotiating position. They could simply licence to each company ££££ and go on to develop AVA3996 and other drugs.

The patent in the US is secure under the filing for IND for at least seven years. I’m not sure about other markets

“Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy”. 🤔 seems like a ✔️ to me!

For those that want it here is the link to the FDA site;-

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

Fast track approval is a process designed to get important new drugs to patients earlier. A request can be made at any time during development by the drug company and a decision will be made within sixty days based on whether the drug fills an unmet need in a serious condition.

SYOR but I’m confident.

Are you reading my emails Timster? 😂

I’m very happy to have the majority of my shareholding in Avacta. The pivot point for me was re-reading the FDA guidance on the process of fast track approval after the announcement of the forthcoming trial of using a two weekly dosage for STS.

Just added another 2330 shares GLA

Should AVA6000 be approved for treatment of soft tissue sarcoma, (which seems to be the path the company is exploring with the FDA) then ODD provides seven years of market exclusivity in the US, which will be a very significant commercial pivot point for the company. Much more significant will be the general proof of commercial concept for the entire Pre|cision platform with a major rerate upwards for the share price on the cards! Al might not do boosts but the results themselves will. GLA

Knotagain my experience (father in law had multiple myeloma and tried doxorubicin but couldn’t handle the side effects so chose to stop chemo). So I agree wholeheartedly there will be demand from patients and we are very close to that tipping point

Thank you 😊

🤔?

RorkesDrift it could always be that part of the new doctors remit (recent hiring) is to review the data so far and publish it?

Bashers* (the FUD crew)