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Strange post BV.

I think Avacta have a good chance to get FT/AA. I base this on the data released thus far, which seems to align with the FDA requirements for FT:

FT:

Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:

Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment

Based on the above, why wouldnt AVA6K achieve FT?

The point of my initial post is that we are completely in the dark, left to make guesses and assumptions, which is extremely frustrating.

I think so also (Ava6k FDA fast track/accelerated approval) but wouldn't it be really great to hear this direct from AS confirming that we have aspirations for FDA fast track / accelerated approval for AVA6K...

I fail to understand why Avacta refuse to discuss this topic which is fundamental to the Ava6k development plan.

He didn't tell us about the plan for ODD pre ODD and has not discussed the ramifications of ODD with us....

I just don't get it.

Short term traders focused on the extended phase1a timeline whereas any genuine LTH sees the vastly accelerated plan towards commercialisation

...He did mention it might be possible to escalate the dose within a cohort but he was talking hypothetically...

While I don't like the lack of comms, it does suggest strongly that AS is uber confident in the company prospects going forward.

RAH, we each own a part of this company. Why should we be left to make guesses?

If C5 has not yet started, it must be for an unexpected reason. Avacta provided guidance on Jan 17th that they expected all additional cohorts to complete by first half 2023, thus they surely must have had confirmed plans in place before sharing this guidance.

On the basis of probabilities, I do expect C5 has already commenced.

With that said, I do hate that we have to guess.

If C5 has not yet commenced it is material news, based on the Jan guidance that the DE stage would complete by H1 23.

While not concerned at all the ambiguity surrounding whether DE5 has commenced or not is frustrating and IMO unnecessary.

Fingers and toes crossed that the news flow commences today!

..

I now think it is likely DE5 commenced on/around Jan 17th. The only difference between the Jan 17th update and the Sept 1st update was reference to the actual dosage.

On Jan 17th we received the following statement:

"On the basis of the very favourable safety profile of AVA6000 in the study to date, the Safety Data Monitoring Committee (SDMC) has recommended continuation to higher dose cohorts with the aim of identifying a maximum tolerated dose (MTD) necessary to inform the dosing levels for the phase 1b and future studies. The Company expects that it will complete these additional cohorts during the first half of 2023."

On Sept 1st:

Avacta's Safety Data Monitoring Committee (SDMC), comprised of clinicians currently recruiting patients, has completed its review of the safety data from the third cohort dosed with AVA6000 at 160mg/m2 in the ongoing Phase I trial. Following this review, the SDMC has recommended that the clinical trial continues as planned and escalates to the next dose of AVA6000 at 200mg/m2.

It is not a wink or a nudge. It is a Clear statement backed by data.

I AM VERY CONFIDENT THAT AVACTA IS GOING TO PLAY MAJOR ROLE OVER THE COMING YEARs'

*You can’t determine the efficacy of a drug with how the CEO looks at the audience.*

True, but you can determine the efficacy of an established drug, that is being dumped via cleavage in substantial quantities into the TME!!! Dr Tap can also determine this, hence he joined the SD in person and his putting his name to AVA6k

The way AS said 'VERY CONFIDENT' reminded me of when he said 'we might not find MTD, now that WOULD BE GOOD WOULDNT IT'

I trust the CEO when he states that AVACTA IS GOING TO PLAY MAJOR ROLE OVER THE COMING YEARs.

Worth watching AS opening remarks.

Listen from 9min in.

"Over the next decade, a revolution in cancer care, I AM VERY CONFIDENT THAT AVACTA IS GOING TO PLAY MAJOR ROLE OVER THE COMING YEARs'

Look at the way he looks at the audience when is says this!

He knows 100% what Avacta is sitting on.

Breast cancer metastized and spread to the liver is still breast cancer growing in the liver.

Sticking with this key objective (Leverage the AVA6000 clinical data to commercialise the broader preCISIONTM platform through licensing whilst retaining AVA6000 as a wholly owned asset).....

Looking at the data it is now highly likely we have multiple license deals in the pipeline. How many is the question?

Within 6 months Avacta could be sitting on a huge war chest of funds, received via initial milestone upfront payments.

With the data just released, Its not unrealistic to command upfront license payments of =>$100m. 10 deals and we could have $1b in the bank, plus AVAk6 retained, and future royalties on all the license deals!

Are 10 deals realistic? Is $100m per deal realistic? Why not?

As above, the Avacta key objective is stated as follows:

Leverage the AVA6000 clinical data to commercialise the broader preCISIONTM platform through licensing whilst retaining AVA6000 as a wholly owned asset.

IF Avacta are to achieve this, how do we see this playing out in reality? What are the models that we could see re AVA6K other than licensing?

Would you consider AVA6K as a wholly owned asset if we were to outsource the leg work (commercialization, production, sales etc) to a big pharma?

I guess this is why Avacta is so keen to retain this asset. It is highly realistic (cos must be >50%) to become first line treatment for STS and that's exactly why Dr Tap was present, in person, yesterday.

As Dr AS stated in his opening remarks, to say Dr Tap had a busy schedule was an understatement, yet had taken time out to join Avacta on their science day.

Dr Tap is operating at the very top tier and undoubtedly connected to FDA and every big pharma. Big pharma will seek counsel from this man.

Dr Tap putting his name (and weight) behind little ~Avacta cannot be understated. The data, potential and probability of success are attracting his attention.