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Is this why we now have the 2w trial...? or am I reading it incorrectly...
However,
'328 when a single-arm trial supports the accelerated approval, and FDA requires a postmarketing
329 trial to evaluate PFS or OS, a separate randomized controlled trial may be needed. Early
330 discussions with FDA regarding the design and initiation of both the trial intended to support
331 accelerated approval and the postmarketing trial are recommended to provide evidence of
332 clinical benefit in an expeditious manner.,
I don't know serious investor be it PI or II who hasn't called it wrong sometimes...especially with AIM...early stage HIGH risk companies in the main...
Companies go t..s up for many reasons...it's part of what investing is all about...
My husband had cancer...all clear for now...🤞🤞
He had two lots of chemo...a year apart...when his oncologist said he should start chemo, it didn't start the next day...in both cases there was a delay of a few weeks. So I think it's plausible that people have only just now been lined up for the trial and dosing started about now.
B2HS2L...Read out of two-weekly and three-weekly dose escalation study data in late Q2 2024"...still good if they were all ready to pending funding...late June...3.5 months for a short 2w study is doable...question is will they still tell us when first 3 dosed
Oh dear F3rdinand...should you really be here, let alone invested!!!
'Avacta is pleased to announce that it will, subject to shareholder approval at the General Meeting to be convened at 11.00 a.m. on 18 March 2024, issue 10,896,948 Ordinary Shares at a price of 50 pence per Ordinary Share in connection with the REX Offer.'
Nov 2023 Kevin Johnson welcomed Eliot Forster as CEO to Levicept
'Kevin Johnson, Chairman of Levicept and Partner at investor Medicxi said, “….I am delighted to welcome Eliot to the company at an important time for the company,…”
Levicept’s investors include Medicxi, Advent Life Sciences, Gilde Healthcare and Pfizer Ventures.
Kevin Johnson is also Chairman of Crescendo Biologics
https://www.medicxi.com/team/kevin-johnson
Crescendo are looking for partners
https://www.crescendobiologics.com/partnering-overview/
and they have two poster presentations at AACR
https://www.crescendobiologics.com/wp-content/uploads/2024/03/240306-AACR-Curtain-Raiser-PR-FINAL-1.pdf
They are also funded by Takeda.
Now would AVA028/032 be of interest to Crescendo...? is this the next pipeline product the funds are for...
https://avacta.com/therapeutics/pipeline/
Connections...Eliot Forster - Avacta & Levicept/Kevin Johnson - Medicxi, Levicept & Crescendo /European specialist healthcare fund (Medicxi ?)/Crescendo - T Cell Immunotherapy/AVA028/032 - 'enhancing T cell activation but avoiding T cell exhaustion'/Fundraiser RNS - 'progressing the current pre|CISIONTM and Affimer® pre-clinical pipelines.'
Hey ho..rock on Monday/Tuesday...
I think we are all getting confused because the 2w has changed the trial format...
Yes it was 1a then 1b then 2 etc
But now due to 2w being introduced...if all goes well they will look to decide their dosing from data produced from 3w and 2w. Depending on the outcomes...safety, tolerability and possibly more efficacy data. Although efficacy is not what the safety 3w and 2w trials are designed for, if good efficacy is seen in 2w they may have been given the go ahead by the FCA to forego 1b (which 2w could be seen to replace) and move straight to 2 starting which will start with dosing expansion and last for just 18 months. Again another reason why they appear to have moved up a notch and are fundraising now the change in trial sequence and the outcome of discussions with the FCA which kinda makes sense to me.
Monday/Tuesday should give us more insight into all of this.
BV...'End of Q2 for read outs is still a nonsense.'...why?
1a (3w) was purely safety...all done...it's deemed safe...the efficacy observed is irrelevant to the trial...
1a/b (2w) is an inserted trial...if it too proves to be safe they will decide how Phase 2 proceeds etc.
Phase 2 dose/structure detrmined by 3w and 2w safety results and will be looking at efficacy and based on the mice trials and results from at least 1a (3w) efficacy should be observed and at this point there is no reason to believe otherwise.
If it wasn't deemed safe at this point they would not be allowed to continue.
If efficacy had not been seen at this stage, would they have continued or not? I think they would because efficacy is not where we are at right now...just safety. Plus 1a was on very sick people with advanced cancer and there was no reason to expect efficacy in patients whose cancer may have already damaged other vital organs etc.
If the 1a trial had been on newly diagnosed patients who had had no other treatments etc, would the outcomes have been different...I bet you they would have been.
Let's see what Monday brings...if anything!!!!
BV...As they say in the US...S..t happens. Timelines can change especially if a company decides to increase their pipeline activity and bring forward new product (s) etc. What we don't know is who has enterest the arena that we don't know about. There is also an election coming up as we all know in both the UK and US and perhaps this is making some II nervous. This fundraise could simply be Avacta getting all their financial ducks in a row early in order to get on with what they need to rather than worry about this years election landscape and how results may affect future funding etc.
On the other hand if they were approached by or entered into any discussions with the European specialty fund prior to the fundraise and they said they'd be happy to come on board with a nice chunk of change now but it would have to be at 0.50 then perhaps it was too goo an offer...and if the same fund said they would be happy to support future fundraisers based on positive trial outcomes then what's not to like...
My point is, we just don't know, but I still go back to the fact they did not have to mention the European specialty fund so why did they and why not name them. We've been told (that gets the financially significant bit out of the way) but we don't have the full story..yet!!!
Icecool...'Good example is in the placing RNS the data readout for 3w/2w is in Q2. If this was anyway delayed as some would suggest they wouldn’t have added this information in the first place to the RNS.' Totally agree and that's why I don't think they were going to actually start to dose 2w until funding secured or at least firm commitments made.
PL75...'Also not sure how a detailed pack containing a ton of info not released to the market gets shown to investors.'
That's what going 'Inside' is all about. As an invester you sign an Insider note whereby you agree not to disclose any info you are given or sell until the rest of the market gets the same info. That's why, IMO, we are not getting any info until the shareholders vote on 18th at which point once the vote is announced Avacta will issue news. Happens all the time...nothing new...just might be new to some on here.
What did you think a trial was going to cost? or did you think it was 'Free at the Point of Need'...
Seems to me there's a lot of Moaning Murtles on here who really don't need to be invested in a High Risk Easly Stage AIM Listed company like Avacta and just got in on the LFT/Covid bandwagon...numpties!!!!
Oh and for those of you who don't know or didn't do your honework:
'The average cost of phase 1, 2, and 3 clinical trials across therapeutic areas is around $4, 13, and 20 million respectively. Pivotal (phase 3) studies for new drugs approved by the Food and Drug Administration (FDA) of the United States cost a median of $41,117 per patient.'