The next focusIR Investor Webinar takes places on 14th May with guest speakers from Blue Whale Growth Fund, Taseko Mines, Kavango Resources and CQS Natural Resources fund. Please register here.
I think that is the plan, Bella.
A Deal on 3996 will fund AVA6K through phase 2 (and some more). AVA6K following phase 2 success (with the direct comparison vs Dox) becomes a multi-billion $ asset.
Does BP wait for the success on phase2 or do they act now based on the data available?
Yorkshirepragma,
Many are actually bought out at earlier pre-clinical stages, with much much higher risks still to overcome and certainly the market opportunity of those bought at an earlier stage is not any greater than that offered by preCISION.
News of a share suspension / BO would surely not come as a surprise at this stage.
Active enrolment has now begun for soft tissue sarcoma patients to the phase 1 clinical trial in the US...
For obvious reasons there won't be any delay between enrollment and 1st dose (these patients don't have time on their side) and as an STS specialist Dr Tap already has a long list of STS patients looking for specialist trial treatment.
Avacta will have initial STS efficacy data from CH5 within a matter of days/weeks, which I trust will support the FDA Fast track / accelerated approval / breakthrough therapy submissions.
In addition to supporting FDA applications, the value of pre|cision increases 10-fold following real data covering STS efficacy, which Dr Tap can easily translate/compare to the mountains of data he has for STS when treated with straight dox.
The study has been designed to be data rich and this next set of confirmed data, albeit predictable, is going to move the needle considerably in terms of asset value / negotiating power.
Although already de-risked hugely at this point, this next set of STS data eliminates risk associated with phase 1B and 2, meaning huge value will be attributed sooner than most think.
Unbeaten anywhere else.
Reward = Unicorn potential
Risk = looks really low at this point. Based on the excellent phase1a data (safety and MoA confirmation), coupled with 50 years understanding of how Dox behaves, we now move to phase1b + phase2 with HUGE confidence.
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.
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.
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.
*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.