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Morning all Looking like same mm tactics as yesterday but not so dramatic so see who comes out on top today. 201 RNS wise i'd like one after hours Friday please its my birthday weekend and hopefully if even half good VAL's prezzie would be the icing on the cake so to say.
From subsequent RNS updates & message board chatter folks expecting positive outcomes to be announced .
"VAL201 Update Mon, 16th Dec 2019 07:00 "release headline results within Q3 2020, which will provide basic details of safety, tolerability and disease impact."
"Until regulatory approval has been reached and all the trial data has been verified, limited preliminary observations can be inferred.
The results appear, in advance of full analysis, to indicate that the VAL201 compound has a clear impact on patients with prostate cancer, as measured by PSA - evidence that is supported from tumour imaging (MRI and CT) in subjects. The compound has also shown it is very safe and has a high degree of tolerability, up to a dose that is in excess of the predicted dose and any practical therapeutic concentration. "
Recently "Half-year Report Mon, 7th Sep 2020 07:00 VAL201 The Phase 1/2 clinical trial of VAL201 in the treatment of men with prostate cancer was closed to further recruitment on 27 January 2020, with recruitment standing at a total of 12 patients dosed across 5 cohorts. The dose escalation was carried out from 0.5 mg/kg up to 8 mg/kg with dosing being carried out once a week.
The trial considered the safety and tolerability of drug administration, alongside pharmacokinetics and disease impact. Although the COVID-19 pandemic lockdown initially cast concern on the time schedules for data verification processes, the project remains on track to release headline results within Q3 2020, which will provide basic details of safety, tolerability and disease impact. More detailed observations on the pharmacokinetics and complete summaries of patient demographics, biochemistry and study conduct will be available when the Clinical Study Report is completed in Q4 2020."
What we do know is that the company have stated they are announcing the Headline results for VAL201 in Q3 and the trading days left in Q3 are starting to run out, the 30 days have now passed since the last directors dealings so news CAN land any day now.
I am not sure if the 201 results need to be published as significant info. Admitly I could be (very) wrong about this. If the company was in financial difficulties I belive that is the sort of thing that is price sensitive and needs to be reported ASAP (as G and S did in light of shareholder rebellion. If the 201 results are good and indicate further product development is warrented then that most probably will mean revaluation of the IP, the value of ValiRx's assets and would be reflected in the SP to the extent that people would be willing to pay a higher price to have a stake in something with legs. (rather than financial difficulties that would indicate the SP could become worthless) It's not quite the same as the direct link to price that financial difficulties (or come think of it, funding) Like I said I could be very much wrong in this, I have no expertise in this. However the 30 day rule could still apply and it not be incondraction with publishing 201 data at the earliest opportunity. Either way if the news is good I don't see what differnce it makes if it is a little later than we have been expecting. If I am wrong about this, please say as we will all benefit (including me as I will learn something) but please back it up with references to legislation or personal experience if possible. Looking forward to good results soon GLA.
Or maybe due to covid, it is just taking that little bit longer... as it is with the exercising of warrants? As many still work under constrictions? Nothing sinister... just a little more patience! Plus with September running into five weeks it could well be the very last week? So with a few more sentiment point rises, we will be sitting pretty, waiting for the... VALdorado Express :)
Ps Grace another couple pooch name offerings... Tilley (lol) Bounce Spike Chase Although im still rather fond of Sp Rocket aka Sprocket :)
Does this mean that those who prepare reports are not allowed to present these to a company if any of it's directors have bought shares within 30 days? For as we know, a company must promptly publish any significant information which becomes available.
There is indeed a 30 day rule which applies to directors dealings.
This rule applys strictly to financial results publication and reading up on this I interpreet it to also apply to market sensitive information such as we have here. Although there are also extra paragraphs covering this area.
So I would expect that now we have cleared that 30 day timeframe results will be close to being released to market.
(ST I’m Still learning here, sorry if a basic question). Last director deal poster was 7th August, so does that mean, if something was ‘imminent’ so to speak, with the inside knowledge you mention, it couldn’t happen until at least a month had passed?
The bigger investors have started taking positions.
Dr Dilly and Dr Cox purchases are significant as they are operating on the 'inside' and it therefore shows they are incredibly Bullish about the prospects of the independent data trials for VAL201 being as good as we all hope
Big Pharma's are circling and we've now seen serious individuals from bigger pharma's buying in.
The Director of Biopharmaceutical Development at AstraZeneca is clearly monitoring this closely.