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.
*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?
April should be news rich. Data at the conference and as per RNS Avacta anticipates that the SMDC will review the two-weekly cohort 1 data by the end of April. All within a new isa and sipp allowance period.
Maybe Alan decimated the Share Price (and overall value of the company) just so big Pharma can swoop in?
They don’t do boosts but they certainly torpedoed the SP with this raise. 50% drop in SP for about a 20/25% increase in the number of shares = a major torpedo! 🚀 not the rocket I was hoping for 😒
Appreciate the replies guys. I guess we all agree the current price is cheap?
It’s not odd it dropped but by this much is of note
Sage my point being the overall value of the company has dropped yet we are now funded and have several value inflection points, including the desire and ability to progress our lead asset AVA6000
So the company now has 350,512,279 shares after issuing 62,296,557 as part of the recent cash raise about 20-25% increase in shares. Yet the price fell about 50% from its aprox value before the rumours ?
I think it might well go a lot higher!
Nice that I called the bounce at 72p be even nicer if I had gone all in then! GLA