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Slacker by the end of the month they’ve said they will review the first cohort of the two weekly trial

Looks like SH are spooked by the open short - becoming self fulfilling 😠

I must admit that I’m not liking this new commercialisation phase so far! GLALTH’s

Good luck Simon Bennett - hope you pass your probation review 😉

I’m just pleased it’s on my radar and also pleased I took advantage and bought a few more at 50p (not pleased at the 50p fund raise though). Two weeks to go until Al explains his reasoning and I think he has timed it to coincide with the end of the two weekly trial (which if this was influenced by the FDA could mark news that inspires a significant upturn in SP🤞). GLA

Certainly hope not Livedataaccount! 😝

So if AVACTA are to submit an application for breakthrough therapy designation (and why wouldn’t they ?) for AVA6000. Based on the reported reductions in side effects (notably cardio toxicity) and safety improvements this should be a given. It’s also likely to be well before the efficacy trials are due to start and following the two weekly dose seems most likely - this could even be why this two weekly trial was introduced?

*Should submit an application before the trial(s) aimed to confirm efficacy

Interesting reading Yorkshirepragma. Page 30 on breakthrough therapy states companies should wait for preliminary clinical evidence that “ the drug may demonstrate substantial improvements over existing therapies” and ‘before initiation of the clinical trial (s) intended to serve as the primary basis for demonstration of efficacy’.

To me that seems to be where we are at with AVA6000 so an RNS announcing breakthrough therapy designation could land any day? GLA

I’ve just been going over the presentation on the investor meet web site and in particular the answer to question 39 on https://www.investormeetcompany.com/investor/meetings/review-of-the-ava6000-clinical-trials-phase-1a-data

is well worth a listen to see why they started at 160 level and to gives an insight into what the results of this arm should show.

E.g. He doesn’t want to sell the golden goose he wants to sell one of the eggs!

Dr Tap roughly quoted - overnight if it works this would become the new standard of care.

The current Dox market (which due to side effects is limited to that figure but with patients tolerating higher and more frequent doses could be worth much more) but is currently worth aprox 1.3 billion a year. Plus this is not the only horse in Avacta’s stable, all means as investors just a little more patience could be all that is required - the stock market being said is a way to take money off the impatience and give to the patience investor. We are in the commercialisation phase with a great salesman (over 80 deals before he joined the team!) let’s hope as Al said it’s about getting the right deal now GLALTH’s

So what’s next? Licensing deal. Bidding war? Progression of AVA3996?

Hoping a steady rise or jumping up of the share price GLA

To summarise yesterdays RNS - it works ! & they haven’t identified a maximum tolerated dose!

My Q (23) also included a response to that -

“Basically if AVA6000 is as good as the company has reported (notable lack of side effects demonstrating a significant improvement on existing therapy) then why wouldn’t the company want to get it used as fast as possible on patients through an accelerated program? Dr Smith has previously stated fast track approval was not a likely option but would Breakthrough Therapy and/or Accelerated Approval match our situation much better? Shareholders and patients will be wondering at the disconnect between the company reporting we have a better treatment and why it is not being used?”

Answer being -

“The Company has designed its regulatory strategy to achieve approval for AVA6000 as quickly as possible through the proposed Phase 2 single arm study in the US. As we confirm our regulatory approach with the regulatory bodies we will make those decisions, and their implications, public. We cannot publicise a regulatory strategy in advance of it being agreed with the regulators.”

GoSushi The question was asked at the investor meet website - Are you working closely with the FDA (discussions, suggestions, guidance) to get AVA6000 approved? Are you applying for Breakthrough Therapy or any other designation from the FDA? Are you applying for any designations from the MHRC or EMA?

The answer being

“We cannot provide further information on the regulatory strategy for AVA6000 other than what was in the presentation. To do so could jeopardise our discussions with the regulatory bodies and potentially prevents us from protecting new intellectual property. We will do so when we have concluded our discussions with the FDA and other regulatory bodies – in mid-2024”.

If we are quoting from the RNS this is the bit that interests me most “

The presentation will include updated data from the Phase 1 trial beyond those included in the abstract.”

Thanks for the link Timster. Nice to see this “The presentation will include updated data from the Phase 1 trial beyond those included in the abstract.”

With the likelihood of several positive updates April and the new tax year could be a great time to buy in here!

Avacta commenced the two-weekly dosing safety study in the US on the basis that this is likely to lead to better efficacy. Within the latest RNS they have committed to reviewing this at the end of April. So we should have a report on the efficacy by then. As per the same RNS the phase 2 study will follow immediately. Might even simply be continuing the maximum tolerated dosages with the same patients?