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Hi Dragon,
Your post helps considerably. Thank you very much for explaining the FDA process. Ironically, it looks as though Stone Checker getting FDA product approval is likely to benefit Feedback when they get around to running their TexRAD Lung product through the FDA process.
Hi Elartu, I follow the company closely, and also don't think there'll be a problem with fda approval. On your point about approval and the TexRAD software employed within the stonechecker product, it would definitely be easier if this software had previously been used within a product, but all fda submissions are product specific so this is not a necessity and would only have helped by making the process smoother. I work within diagnostics and we have a technology which is used on tests, and this undergoes a new fda submission for each product it goes into. It obviously helps that we've been through the process previously, but each product is treated differently and assessed thoroughly as it's own product. 510k submissions are slightly different in that they are assessing against a predicate, which makes the process easier again. Not sure if this helps but these are the reasons I don't see that as an issue
Good morning Shan & Draft,
Draft, as per your post, I am not forgetting Imaging Biometrics, it's just that I am not that interested in them as my main focus is on TexRAD at present. However, if you could supply me with IB's income and expenditure figures over the past 2-3 years I will endeavour to take a closer look.
Shan, I am currently only invested in Feedback. I have trust issues with one of the board members of Flying Brands which is why I was asking the posters here as to how they were expecting to get FDA approval for the Stone Checker product when the TexRAD software analytics that is core to its usage has not yet gone through the FDA approval process.
You all seem quite happy that this isn't going to be a problem but didn't elucidate as to why that was the case other than the company was working closely with the FDA. I decided not to push the matter further.
I note however Shan that you seem to think Feedback need more money (almost certainly correct) whereas Flying Brands are 'fully funded' (almost certainly incorrect). I will attempt to demonstrate why I believe you are incorrect regarding Flying Brands.
In the company's half year report the cash position as at 30th June was £5,000.
The company then raised via a placing in mid-July a sum of £500,000 to keep the lights on.
This exercise cost the company £84,000 leaving FBDU with a sum of £416,000.
It planned to spend the money as follows:
A PACS compliant software plug in for Stone Checker - £80,463.
Imaging Biometrics – cash for operational expenses - £60,000.
FDA fees for Stone Checker - £48,161.
COO's wages - £110,000.
Payment of other wages, legal fees, accountancy fees, UKLA and LSE fees, printing costs, consultancy fees, Stone Checker software trials, developing improved products - £200,000.
That's a total planned expenditure of £498,624.
Now here's the crux for me. In the last 6 months the company lost before tax £371,000. That's a loss of £61,833 per month.
So, with £416,000 raised that might keep the lights on another 6-7 months or just under 6 months if you add in the new COO's wages.
Look at what they raised, and look at the proposed expenditure. How much of it benefits and pushes the company forward and how much of it benefits the people within the company?
So, FBDU had next to no cash at the end of June and the £416,000 they received from the placing will likely last them around 6 months. Shan, I don't view this company as 'fully funded' like you say. In fact, unless Draft can show me immediate exceptional profits arising from IB, I would anticipate your board going back to the market for more cash around Christmas / New Year.
The wood from the trees is your totally forgetting Imaging Biometrics, already FDA approved, and already making sales and signing top strategic partners like Qmenta and ECOG for the cancer trials.
Evening Elartu,
In these matters with the FDA you often have to leave it to the people in the know and if you trust the BOD and they have communicated pretty openly then I am confident with their Chance of success and the timeline.
My main experiences of the FDA are based on drug submissions but if you have a co-operative relationship then it is usually fair,y straightforward.
Scott Gottlieb is keen on improving the efficiency of FDA Approval and would not worry about Texrad software not been Approved
OK, I get that FBDU are cosy with the FDA and that you all believe the FDA are just a signature away from signing off the 510(k) regarding Stone Checker and moving on to starting the actual FDA procedure. But I still can't get my head around how this is about to be done when TexRAD software, which Stone Checker readily admits is the algorithm it uses "to examine heterogeneity and ‘texture’ not visible to the naked eye", has not independently gone through the FDA approval process. TexRAD currently doesn't have a completed US Patent Application, let alone a completed 510(k) process or any FDA approval. So, it still has quite a few hurdles to clear in the US.
Assuming all this is not a problem according to you guys then can you please explain to me how Stone Checker has leapt these same hurdles. Does Stone Checker have its own US Patent or is it waiting for the 510(k) process and the FDA application processes to be successfully completed before applying for one? Or is it not bothering to patent at all as Stone Checker is merely a very fancy user interface and TexRAD is the only part of it that is valuable and unique enough to warrant a US Patent?
Sorry to be a nuisance but I just can't see the wood for the trees in all this.
The fda is in the bag. This is not Akers bio which had a ton of problems. The question is when will they get it and how will this then impact on other sales ?
its about relationships and its pretty obiovus the FDA approving this - as they worked on the 510k submission with FBDU - they probably wont even query texrad
...
https://phys.org/news/2018-09-kidney-stones-distinct-geological-histories.html
Qmenta wins contract for Alzheimer's trial
By AuntMinnie.com staff writers
September 13, 2018 -- Advanced visualization and image analytics software developer Qmenta has won a contract to provide imaging data management, analysis, and visualization services for an upcoming Alzheimer's clinical trial of the AMX0035 drug candidate from Amylyx Pharmaceuticals.
The Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease is known as PEGASUS. With its cloud-based neuroimaging platform, Qmenta will help Amylyx analyze MRI data collected as part of the trial, it said.
The trial is funded by the Alzheimer's Combination Therapeutics Opportunity initiative, which is a collaboration between the Alzheimer's Association and the Alzheimer's Drug Discovery Foundation.
Great post Scott. Very optimistic here
A brilliant half year report if i do say so myself!
Very bullish indeed and with the new CEO and Nick Stevens picking up chunky amounts of shares, it says a lot where they think we're headed.
I notice this in the report...
"This dialogue with the FDA has resulted in the adoption of a new predicate software product which the FDA has agreed will result in a more efficient and definitive approach with a clearance decision expected in Q3/4."
A few paragraphs later..
The FDA acknowledged receipt of IB's renewed submission in August 2018. The FDA publicly states its performance goal is to process 510(k) submissions within 90 calendar days and based upon their published results, the majority of decisions are rendered within this period.
So possibly FDA may be delayed slightly to Q4. The lastest possible time being in November at some point.
Post period end, successful completion of £500,000 capital raise at 2.5p ensuring sufficient financial resources for at least the next 12 months.
Fully funded for at least the next 12 months meaning no threat of placings. Company have always been honest and trustworthy on this front.
David Smith, Operating CEO. Strategic overview and introductory statement:
"I have worked in the medical device business for 30 years, and as an entrepreneur in the field for the last 15 years, seeking out opportunities to improve patient healthcare and create outstanding value for shareholders.
I think David and ourselves are going to get along great!
So then, to finish up..
Some of us have been here for over 2 years back when this company was nothing more than a cash shell, so much progress and change has happened since then, none of this never really reflected in share price. However we're now on the home straight. C/E approval in the bag, FDA approval very likely to be awarded in the near term and commercial sales set to commence in Q4, with revenues expected before the end of the year. We are about to enter into the most exciting and promising moments so far for us FBDU holders. 2019 could seriously be that re-rate year we've been waiting for. Don't take my word for it though, look at the director buys over the last couple of days, immediately after the closed period had ended.
If you really want to dream though, how about a buy out by the likes of Google? If we nail this market globally then that could be a very real possibility.
ATB.
dont be,silly. market shows no interest
strange going on!
I bought cheaper than I could sell?
follow the money ;)
B Rad Tech will be used to assess brain tumour treatment response in multi-center trial
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Imaging Biometrics®, LLC ("IB"), a wholly-owned subsidiary of Flying Brands Limited (LON:FBDU), and the American College of Radiology Imaging Network ("ACRIN") have united efforts in a multi-center Phase II trial sponsored by the Eastern Cooperative Oncology Group (ECOG)-ACRIN Cancer Research Group. The study will use IB Rad Tech™ to post-process datasets acquired from over 20 US sites to determine how well dynamic susceptibility contrast magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with recurrent glioblastoma, and to ultimately correlate changes in rCBV to overall survival (OS) and progression free survival (PFS).
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Patients enrolled in the study will undergo a DSC-MRI exam right before beginning treatment with bevacizumab (Genentech, San Francisco). After the baseline exam, follow-up DSC-MRI exams will be scheduled prior to the second dose administration of bevacizumab, typically 2-3 weeks after the initial dose. In total, 165 patients are estimated to participate in the study.
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IB Rad Tech, a customizable software interface, acts as a "workflow wizard" to guide users through a series of automated processing steps. The specific workflow used in this study will leverage IB's FDA cleared software modules IB Neuro and IB Delta Suite to easily determine the tumor region of interest (ROI) and compute DSC-MRI-based normalized and standardized rCBV maps. Exclusive to IB, standardization is a machine-learned calibration approach that translates relative MR values to a fixed and consistent scale regardless of scanner vendor, field strength, or patient. The ability to automatically generate quantitative rCBV values consistently, independent of scanner or timepoint, makes it ideal for longitudinal assessment of treatment response.
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ACRIN Principal Investigator Jerrold L. Boxerman, MD, PhD, Associate Professor of Diagnostic Imaging at The Warren Alpert Medical School of Brown University and Fellow of the American College of Radiology, said "This study will help determine if rCBV can serve as an early response imaging biomarker to an anti-angiogenic agent (bevacizumab) in patients with recurrent brain cancer. If successful, rCBV will lead the way for the incorporation of more advanced imaging biomarkers into clinical trials, which should help to improve the development efforts for new cancer treatments. IB Rad Tech's ability to quantify how patients are responding to treatment will provide for a more robust study and greatly simplifies the post-processing of the numerous datasets that we will acquire."
Michael Schmainda, CEO of IB said "We are delighted IB Software was chosen for this important multi-center trial. Our quantitative analysis resolves many inconsistencies that have inhibited routine and robust brain tumour assessment, and has
ixicos a big avoid right now - its already risen. we also have a phase 2 trial
Anybody seen Ixico. Contract landed with top ten pharmaceutical company. Massive rise. Maybe one day this will be us
Now that’s a show of confidence
Flying Brands, the parent company of StoneChecker® and Imaging Biometrics® focused on advanced and state of the art medical software and services, was notified on 10 September 2018 that David Smith, CEO to the Operating Subsidiaries of the Company, acquired 1,000,000 ordinary shares in the Company on 10 September 2018, representing 0.83% of the Company's issued share capital, at a price of 2.48 pence per share
on open market.... the 1m share buy was him. Great show of confidence
https://www.voxmarkets.co.uk/rns/announcement/eaa8fae2-7044-4d82-9df8-5a9aaaef6559/
Will
a) either paying more later
b) probably cursing us for walking off with the major reward
It is quite obvious David Smith aint messing around. We are well placed to GLOBALLY send out both existing software. An of course can not rule out further acquisitions in maybe the lung or cardiac space.
someone with deep pockets mopping up the weak.. some questionable trading by some who will likely regret bailing in due course