Member Info for Wiggly

First mover advantage...

I'd be amazed if AZN, TAKEDA AND NOVARTIS, were not all now 'inside' with access to the live data. Why would they not have requested access to the trial data?

Whoever moves first wins (assuming they offer enough for exclusivity )

I read many believe deal will follow data read out however that's a risky strategy for those serious about licensing this tech.

Is there someone prepared to make an early move? A lot to win by doing so and a lot to lose by delaying.

Out of interest how quickly could Avacta execute a Nasdaq listing?

With good data Avacta will have multiple funding ( licence ) options however, for those 'specialist' investors state side, the Nasdaq finance route with;

1. Positive PK
2. Biopsy data
3. ODD for STS (BIG SELLING POINT for new investors)

Is a hugely compelling IPO. Massive. Imaging the interest that this would generate.

Is 2022 Nasdaq listing an option or would we be looking at 2023 (assuming AS preference is Nasdaq) ?

While not (yet) fully evident in the share price the industry big players are most certainly watching closely.

Azn SR director of early oncology and Novartis head of licencing both liking the recent Avacta ODD post.

Novartis must have some interest to licence otherwise why would their head of licensing be liking Avacta LinkedIn post?

Would PNT be considered a qualified researcher?

Plan Description: Qualified researchers may request access to individual patient-level data through clincialtrials@avacta.com

You would assume that PNT have access to the live Clinical data from the AVA6k trial?

From the RNS:

'POINT intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and investments, to fund clinical and preclinical research and development programs, pre-commercialization activities, and for working capital and other general corporate purposes'

The Point Pipeline (below) is not huge, thus when they say they are raising to fund their pre clinical Development Programs, there is a high probability that they will be funding CanSeek..

https://www.pointbiopharma.com/our-products/pipeline

Splash failed? It's not clear from the announcement.

Agree though, RAH, if it has failed then they better action their plan b strategy ASAP.

POINT announced a poster presentation for SPLASH and it dropped 30%? Any insight ?

Multiple non dilutive options exists however, if the BOD decide to retain 100% of preCISION in-house then do you believe the previous backers, who valued at 120p prior to the trial, would now value at less than 120p following a positive P1a read-out?

If Avacta deliver a positive read out , declaring improved safety + tolerability with positive biopsy data then there is a high probability we could see quick fire license deals for each of the below.

Can you imagine at $50-100m per deal with development costs paid?

• preCISION Velcade analogue (AVA3996)
• preCISION Paclitaxel
• preCISION Oxaliplatin
• preCISION Gemcitabine
• preCISION Capecitabine
• preCISION PARP inhibitor
• preCISION PD-1 Inhibitor
• preCISION AKT inhibitor
• preCISION Balixafortide

That the market finally wakes up!

Some additional points added.

Would Avacta move to secure Orphan drug status, 10 months into the trial, if pre|CISION was not working?

Would the SDMC recommend DE to 200mg if pre|CISION was not working ?

Would Avacta progress 3996 if preCISION was not working?

Would Avacta have hired a Principal Scientist (>1 years into trial) to combine preCISION with TMAC if preCISION was not working?

Would AS really comment that licensing the lead asset would be a mistake if preCISION was not working ?

Would Avacta be VERY pleased with progress if preCISION was not working ?

Would Avacta continue to fund the trial if biopsy data was not encouraging ?

Would SDMC recommend increasing the dose if biopsy data was not encouraging ?

Would FM have joined if the initial clinical data was not encouraging ?

Would Dr CC have joined, >1 year post first dose and 6 weeks post first DE, if preCISION was not working?

Would Neil Bell have commented that DE to 160mg was an 'endorsement of the emerging safety and tolerability profile in the patients enrolled in this study to date' if preCISION was not working?

Would Avacta have moved to London, at considerable increased expense (with cash running low according to TW) if clinical data was not encouraging?

Would the team have travelled to the USA to present the pre clinical if the clinical was not encouraging?

Even the greatest pessimist must find it hard to deny that preCISION must be working??

AS, true to his word, will not discuss the clinical data until read out.

It would be nonsensical for AVCT to apply for ODD status If Precision was not WORKING for STS.

Approved based on pre-clinical. Submitted based on clinical!

Must be!

Under section 902 of FDASIA, a breakthrough therapy must meet two general criteria: 1) It must be intended to treat a serious or life-threatening disease or condition; and 2) there must be early clinical evidence indicating "that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints." The manufacturer must present this clinical evidence when it applies for breakthrough designation, and the FDA must respond to the application within sixty days of receipt. The FDA may also rescind the designation if further evidence reveals that the drug no longer meets the qualifying criteria.

I'm going to speculate that the non mandatory Biopsy data was required to support point 2 above.......

It stands to reason that Avacta will have submitted for both ODD (designated) and breakthrough therapy designation at the same time.

The FDA ODD for AVA6K is major news in the number of ways. The news is material and should have been announced last week.

Interesting read below:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477091/

Conclusion
The purpose of this study was to study whether the Orphan Drug Act has been successful in incentivizing drug development for rare diseases, by analyzing the investor valuation of the orphan designation. The results indicate that the designation has been successful in this area: investors place positive, statistically significant, value on the orphan drug designation. These results were especially pronounced for oncology drugs and the smallest companies.

Please see point 4 below. Looks as though Ava6k will be fast tracked under the Breakthrough therapy designation.

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

For purposes of Breakthrough Therapy designation, clinically significant endpoint generally refers to an endpoint that measures an effect on irreversible morbidity or mortality (IMM) or on symptoms that represent serious consequences of the disease. A clinically significant endpoint can also refer to findings that suggest an effect on IMM or serious symptoms, including:

1. An effect on an established surrogate endpoint
2. An effect on a surrogate endpoint or intermediate clinical endpoint considered reasonably likely to predict a clinical benefit (i.e., the accelerated approval standard)
3. An effect on a pharmacodynamic biomarker(s) that does not meet criteria for an acceptable surrogate endpoint, but strongly suggests the potential for a clinically meaningful effect on the underlying disease
4. A significantly improved safety profile compared to available therapy (e.g., less dose-limiting toxicity for an oncology agent), with evidence of similar efficacy
5. A drug that receives Breakthrough Therapy designation is eligible for the following:

All Fast Track designation features
Intensive guidance on an efficient drug development program, beginning as early as Phase 1
Organizational commitment involving senior managers
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy

I would say yes, 100% AVA6k has been Orphan drug designated.

https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products

The market reaction has been the only element that makes me question my own view here however, I raise the questions below to myself and the answer to each points towards pre|CISION working.

When will the market wake to the story that is developing here ?

Would Avacta move to secure Orphan drug status if pre|CISION was not working?

Would the SDMC recommend DE to 200mg if pre|CISION was not working ?

Would AS really comment that licensing the lead asset would be a mistake if preCISION was not working ?

Would Avacta be VERY pleased with progress if preCISION was not working ?

Would Avacta continue to fund the trial if biopsy data was not encouraging ?

Would SDMC recommend increasing the dose if biopsy data was not encouraging ?

Would FM have joined if the initial clinical data was not encouraging ?

Would Avacta have moved to London if clinical data was not encouraging?

Would the team have travelled to the USA to present the pre clinical if the clinical was not encouraging?

Even the greatest pessimist must find it hard to deny that preCISION must be working??