Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
Definitely taking the p now “ These arrangements continue to align the interest of the Executive Directors with the longer-term share price performance interests of our shareholders.”
I’ve submitted a question asking how well they think they’re doing on their mission statement about growing shareholder value? & when we might see value reflected in the share price.
Yorkshire - Looking at what the Dec RNS stated, to increase efficacy data is what the two weekly study has been designed for - “The next steps with AVA6000 involve optimising the patient population, dose and schedule in order to increase efficacy and tolerability of doxorubicin treatment via pre|CISIONTM targeting. That Dec RNS also stated that safety data had been obtained and this has later been reported at the AACR conference along with the unexpected efficacy data from the 3 weekly study (unexpected because this population wasn’t selected for efficacy - which I believe the two weekly population will have been selected for) we have been told the first cohort weekly cohort data will be reviewed at the end of the month by the SDMC so hopefully on the cusp?
Wyndrum - the FDA may be unwilling to grant AA in the basis of the safety data alone as this is what phase 1 trials are all about usually - the pivot to unexpected 2 weekly may be to provide greater efficacy data which could trigger AA?
Yorkshirepragma looking at the document you posted the link to, at the bottom of the table on page 3 seems to be likely where we are with AVA6000 - on the cusp of AA. After phase 1 but before phase 2?
It also mentions the FDA can grant AA and approve drugs purely on the basis of tumour reduction - a surrogate endpoint. A threshold we seem to have reached and this two weekly trial might be the pivot towards providing the data that the FDA would need?
Yes Thornogson but also this might be the whole reason for the two weekly trial to prove decisive data to the FDA for accelerated approval? We know Avacta have been in discussions with the regulators and they have hosted big pharma. It could all change very quickly.
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!