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Are we done here guys? 40 votes thus far
means we are still at least 4% short of total voting rights to force a vote. A notice will be served in any event but it would be helpful to have more indicative support so we can demonstrate strength of discontent here.
Please simply tick up this post if you have in excess of 30,000 ordinary shares in Avacta Group Plc (Avacta) AND you wish to participate in serving a notice on Avacta to convene a General Meeting to hold a vote on whether to remove Dr. Smith as CEO of Avacta. We would also need to propose a replacement. This is a simple exercise to see whether we have 5% of the voting capital to serve a formal notice on Avacta under the Companies Act 2006, in which case they would be under legal obligation to hold a General Meeting in which all shareholders could vote be a simple majority to remove Dr. Smith as C.E.O. of Avacta. If there is sufficient votes then we can move forward.
In October 2016 FDA granted olaratumab fast track and breakthrough therapy designation, priority review status, and accelerated approval for the treatment of patients with soft tissue sarcoma (STS).
Approval was given in October 2016...
Approval was based on data from a randomized, active-controlled, clinical trial involving 133 patients with metastatic STS.
Oct 2016 Approval FDA Grants Accelerated Approval to Lartruvo (olaratumab) for Advanced Soft Tissue Sarcoma
May 4, 2016 FDA Grants Priority Review For Lilly's Olaratumab, An Investigational Medicine For Advanced Soft Tissue Sarcoma.
So, it can be seen there is every chance (liklihood) that AA will be granted to AVA6000 in a similar timescale, not least as FDA are already closely involved in approval for dosage regimin.
I wonder whether"First line treatment" is a bigger deal than has been made of today. To me it demonstrates the active involement of the FDA (no doubt in association with Dr Tapp) to fix on a two weekly dosing regimen with the principal focus on getting AVA6000 approved for use in STS patients asap. This leg of the trial could be substantially expedited by the very fact of the fortnightly dosing regime, meaning an application for FDA approval could really be fast tracked. No doubt it will still take time to compile and submit clinical results (a few months I would have thought) but if he FDA are already actively engaged, they could really pull out all the stops with an expetided approval for AVA6000 under the Orphan scheme in place.
100% agree. We are so far ahead of the curve. I think about how much time and effort I have put into understanding the technology, the platform and the addressable market size. I feel sure I could explain the benefits and characteristics to a cancer specialist who deals with one of the cancers we are not targeting and not make a complete idiot of myself. I think they would grasp the potential and once absorbed the data we have been presented with to date, they would be as excited as we all are for the now likely implications of the roll out of AVA6000 and then the rest of the pipeline. It takes an investment in terms of research and most simply don't have the bandwidth or know how to go about finding out about opportunities like this. Not long know till a AVA6000 story is shared with the world and then stand back! Early crypto investors indeed!
BTC and ETH regarded as assets not securities so not impacted by the proposed bill. Altcoin however likely to fall with the current remit of the amended Bill (at time of writing) as brokers and thus subject to additional KYC requirements. I was bearish BTC but held ARB and will now be adding as I believe BTC will be 100k USD by year end. GLA
To this very question don't forget this little beauty from the Q & A in the 2019 Accounts:
How confident are you that the phase
I clinical trial for AVA6000 will be successful and will the
COVID-19 pandemic cause significant delay in starting the trial?
The animal data are very compelling. The improvement in therapeutic index of doxorubicin in the form of
the AVA6000 pro-drug is not marginal, it is black and white. This gives us
a high level of confidence that we
will see these data reflected in
a positive phase
I study in cancer patients. We will conduct this clinical trial
in the UK and are working now to complete the stability studies that will finalise the regulatory package
and allow us to submit this to the MHRA.
A reduction in staffing levels within our contract manufacturing
and clinical operations partners has not caused
a significant delay to date but this may mean that there
is
a short delay in the regulatory submission for the AVA6000 clinical trial to the MHRA into Q3. Many
clinical trials have been halted due to the pressure on clinicians and hospitals during the current COVID-19
pandemic. We do not expect there to be
a significant delay but it is prudent to assume
a short delay in
starting the AVA6000 phase I study perhaps into early Q1 2021. This also means that the associated costs
are delayed, and there is sufficient cash on the balance sheet to complete the phase
I trial as well as
progressing our other programmes.
"HIGH LEVEL OF CONFIDENCE"
Ps great to see £2 again. hopefully we will build on from here!
7 August RNS: "LSTM is currently evaluating the performance of prototype lateral flow tests provided by Cytiva alongside Avacta's ELISA laboratory test using SARS-CoV-2 coronavirus samples, as a precursor to full clinical validation studies."
prototype tests were being validated by LTSM by 7 August. They know the damn thing works. It is certain the pilot batches being produced by Abingdon will exceed clinical validation. They will scale up manufacturing as they await final sign off.
AS seems to have his sights on mass global population screening. Wow!!!
From Mologic's news release this morning: Findings will complement the Government’s own learnings about usability of rapid point of care tests as it will strengthen the research being done in this area by trialling alternative suppliers. As confirmed by Mologic the rationale was to "complement the Government's own learning" (i.e. Condor) by trialling "alternative suppliers". Avacta’s test would implicity not be included in Heathrow's testing programme as they ARE in Condor and the Government ALREADY KNOW full well that Avacta’s test is gold standard. All good here. Hold for gold.
around the corner imho. Any sniff of deals with other global manufacturers and the price will rocket. Anything above 90/90 sens/spec and the price will rocket. Miton cleared, the price will rocket. We have seen just how quickly the price can move (both upwards & downwards) which is primarily due to the low number of free float shares. We make returns by being ahead of the curve and taking positions on the basis of research. This forum is amongst the best of the very best for the depth of research and I thank all the contributors helping us to all continually assess and re assess our own researches. We are hungry for news. That hunger will soon be satiated. The life changing value of this company is about to begin to be realised! My personal sights are set on the validation of the pre cision platform. That enables me to adopt a long term view and disregard the temporary fluctuations. True value takes time to be realised by the masses and that is our edge. End of the beginning. GLA
My average is 8p. I haven't been following for a long time. Are long-termers averaging down now with renewed confidence in this share? Do we expect a placing any time soon? thanks in advance to other long term sufferers!!
understood but that was my point. They ought not to have locked them in to Avacta’s test, given the links etc. Seems to weaken our offering somehow. A commercial point for the parties but if they were well advised they would not have conceded it IMO. They had the bargaining power not to.
doesn't exclusivity both ways imply that Medusa couldn't sell other 'competitors' tests? That would certainly be my understanding anyway. Now whether an antibody test can be said to be a competitor test is another question but given the links between the two companies one would have thought that the deal ought to have been struck in the way that I am suggesting. If indeed they are marketing two tests!
piece from 27 July on same test.
https://tinyurl.com/y5yw7hb7
3M have a test that is a pregnancy style test and 10 mins but does require 'minimal training' to administer. they are talking in this piece about scaling up globally. A test with no need for training (i.e. Avacta's) is evidently infinitely more useful.