Member Info for Hedgehog100

Afternoon Ivyspivey!

Thanks, and thanks for the correction - David Smith did of course say "urologists", not "neurologists".

More extracts from Wednesday's video interview, where David Smith is talking more about the imminent FDA approval for their StoneChecker software product, and about what happens afterwards:

" ... Michael Billig ... he runs a group called Experian Consulting, based in San Jose ... he has a 100% track record of getting approvals ... he's got very close relationships with the FDA. So supremely confident in our FDA application process.

... We launch in the US immediately. I know that people check, frequently, on the FDA website to see if the 510(K) has come through, and I can assure you that won't be the first place that they'll hear about it, because we'll issue an RNS. But the, I think that the FDA update their website weekly, on a Monday, so there tends to be a lag between it happening and actually being notified. But we'll get the message out immediately. We have our channel partner, CorTechs Labs, that we signed up a few weeks back, who are trained, primed, and ready to go. They have around a dozen sales reps. in the US. So they give us that dimension. And we'll be presenting it at the many medical conferences that we attend. So it'll be a case of all systems go."

https://www.proactiveinvestors.co.uk/companies/news/314281/iq-ai-s-david-smith-on-the--immense-market--for-its-gadolinium-free-imaging-product-14281.html

Some extracts from Wednesday's Proactive Investors video interview (31.7.19), where David Smith is talking about the imminent FDA approval for their StoneChecker software product:

"It's almost like the Inland Revenue owing you tax money back, and you go to the mail box every morning expecting to find a cheque in there that you can deposit. Let's just say I'm checking my mailbox every morning.

It hasn't slowed us down. We are in fact fine tuning our US marketing approach. Just this week we've sent a communication out to 750 European neurologists, giving them the opportunity to evaluate StoneChecker free of charge for thirty days. The intention is they look back at patients that they've treated with this lithotripsy, the sound wave energy to break up the kidney stones. And we want them to try StoneChecker to see what StoneChecker would have predicted would have happened, and in that way build confidence about taking on board the product.

Anything we learn from this of course we'll implement in out imminent US launch."

https://www.proactiveinvestors.co.uk/companies/news/314281/iq-ai-s-david-smith-on-the--immense-market--for-its-gadolinium-free-imaging-product-14281.html

"Very true Hedgehog100.Have seen your excellent posts over on the other site.Any chance you could post some of them over here?"

Thanks Shakeyerbooty, and thanks again for your excellent summary: its 8 Recommendations shows that it is much appreciated.

I will post some of my ADVFN posts over here this weekend, as requested.
This will be a good opportunity as it's quiet.

Thanks for that list Shakeyerbooty.

Sales are actually forecast to MORE than double in 2019: who's to say that they won't actually treble, if a few $100K. + sales are signed off before the end of the year.

Thanks for the reminder of that excellent recent article Howdlep, which shows that we have disruptive technology at its very best.

IQAI's ground-breaking technology strongly supports the investment case here.

And the technological barriers to entry are high.

This is a tribute especially to Kathleen Schmainda, the founder of IQAI's US subsidiary Imaging Biometrics.

In the words of IQAI's David Smith, she's a luminary in the field, and it's based upon her reputation that we're asked by other companies in the field to help them write their software, for a fee obviously, and help them get regulatory approval.

In fact, her role in IQAI could be likened to the role of Steve Wozniak in the early Apple Computer.

To compare to IQAI's StoneChecker Software product's potential:

The overall kidney stones market is forecast to be worth at least US$3 billion p.a. by 2023 as their prevalence grows, driven by risk factors such as obesity and high protein diets.

But despite this, relatively little funding is given to research and development in this field.

Stone Checker Software Ltd. is addressing this unmet clinical need, and clearly has a quite enormous growth opportunity: and in what is perhaps the hottest area of the stockmarket, i.e. meditech AI ... though one that really seems to have legs.

And kidney stones affect tens of millions of Americans during their lives.

From Fortune.com:-
"Kidney Stones Are on the Rise in the United States
By‚ EMILY PRICE‚ February 13, 2018
A new study suggests that both men and women in the United States are getting more kidney stones.
Between 1984 and 2012, kidney stones diagnoses increased more than fourfold among women and twofold among men, according to the study published Monday in the Journal‚ Mayo Clinic Proceedings‚ and reported on by‚ CNN‚ .
Kidney stones are common, affecting roughly 10% of the population at some point in their lives. ... "

As the population of the US is 329 million, and growing rapidly, there is clearly a huge and growing market for StoneChecker software in the US.

"ABOUT
Stone Checker Software Ltd is a health technology company focused on the development and commercialization of products to inform clinical management and to guide care for patients with kidney stones. The company is led by recognized experts in the field of clinical development and commercialization.
More than 300 million patients worldwide suffer with kidney stones and the majority of these are working age adults. Despite these numbers, relatively little funding is given to research and development in this field. Stone Checker Software Ltd aims to address this unmet clinical need by providing novel products for the healthcare market.Stone Checker Software Ltd is wholly owned by IQ-AI Ltd; a publicly-listed company on the London Stock Exchange: IQAI."
http://www.imagingbiometrics.com/what-we-offer/product-services/ib-stonechecker/

Degsy,

Thanks for drawing our attention to Shield Therapeutics (STX).

STX rose 69.1% yesterday (Friday) to 175p, market cap. £204.9M.

And indeed STX has now ten-bagged over the last sixteen months.

IQAI is starting from a much lower base that STX though, and the potential upside is far higher.

26th Jul 2019 7:00 am RNS Shield Therapeutics - FDA approves Feraccru® with a broad label

"London, UK, 26 July 2019: Shield Therapeutics plc (LSE: STX), a commercial stage, pharmaceutical company with a focus on addressing iron deficiency, announces that the U.S. Food and Drug Administration (FDA) has approved its lead product Feraccru(R) / Accrufer(R) for the treatment of iron deficiency in adults.

With this broad label approval Accrufer(R) (as the product will be marketed in the USA) has taken a big step towards exploiting the very large commercial opportunity in the USA, the world's largest and most attractively reimbursed pharmaceutical market. Market research suggests that the prescription market for iron replacement therapy in the USA is worth over $1.0bn annually. There are between 8 million and 9 million patients in the USA who suffer from iron deficiency anaemia and management estimate potentially two to three times this number require treatment for iron deficiency. ..."

https://www.lse.co.uk/rns/STX/shield-therapeutics-fda-approves-feraccru-with-a-broad-label-5twg3gi6qeiqqbo.html

Bertie,

You mean the FDA. not the PTO.

StoneChecker was originally submitted to the FDA in May 2018. Under the FDA's 510k guidelines, manufacturers are required to compare the new product to an existing FDA cleared product. This represented a challenge since StoneChecker has some unique features which are not found in other "predicate" products. A CT machine software was chosen to establish "substantial equivalence" to StoneChecker, but after several discussions with FDA it was mutually agreed that a different comparator device be used. Consequently, the 510k package was resubmitted to them and they formally accepted it on 22 August 2018.

Since then other hurdles in the approval process have been crossed, and my sense is that approval is now very close.

It's a rule of thumb that things do tend to take longer than expected. But it's also true that if you're going to get there, you do so eventually. And I think that more than sufficient time has now elapsed.

The word "shortly" was used in IQAI's 30th. April update (which was well-received):

30th Apr 2019 12:00 pm RNS IQ-AI Limited - Publication of Annual Report
" ... The Company is in the final stages of securing FDA approval for the StoneChecker software product and we hope to announce marketing clearance shortly, which would give the Company an additional and important revenue stream in the US during the 2nd half of 2019. ... "
https://www.lse.co.uk/rns/IQAI/iq-ai-limited-publication-of-annual-report--r71ph7b8psdaq3w.html

This was then 'upgraded' to "very soon" in David Smith's 12.6.19 interview (which was even better received):

" ... no additional substantive questions that they wish to ask."
" ... simply in a queue waiting for it to pop out the other end."
" ... hope to announce that news very soon."

Clearly though they are talking about their hopes, on a matter that isn't directly within their control.

And short term traders may have a shorter definition of "shortly" than businessmen.

It will come, but there's a queueing system, and IQAI have had to wait their turn.
That's the only fair way of doing it.

Here's hoping that they are now right at the front, and that the approval is being rubber stamped as I write.

It's only lost a bit of momentum in the short term, and that can change very quickly. -

"Technical Analysis for IQAI - IQ-AI Limited"

"Trend Table & Recent Signals
ADX Long-Term Intermediate-Term Short-Term
Very Strong Up Up Down "

https://lse.swingtradebot.com/equities/IQAI:LSE#/

Thanks to Kiwi for posting this article on Wednesday -

"Kidney Stone Management Devices Market to Reach US$ 1,500 Million by 2028; Global Sales Likely to Surpass 1 Million Units, Reveals Fact.MR
PRESS RELEASE PR Newswire
Sep. 20, 2018, 06:30 AM
https://markets.businessinsider.com/news/stocks/kidney-stone-management-devices-market-to-reach-us-1-500-million-by-2028-global-sales-likely-to-surpass-1-million-units-reveals-fact-mr-1027550530

There are more than 7,200 hospitals in the US alone, so the potential market is vast.

IQAI's StoneChecker software product could generate a multi million pound stream of annually recurring revenue, at juicy margins.

And this is just one of IQAI's multiple products, some of which have even greater potential than StoneChecker.

IQAI is a technology leader.

It's groundbreaking products are disruptive technology at its finest, offering improved performance and big savings.

And the high technological and other barriers to entry make it difficult to compete against.

Allied to the brilliant business and sales nous of Trevor Brown and David Smith, and it's the perfect combination for a tip top growth stock.

FDA approval is lengthy and costly (IQAI's original submission of StoneChecker software was in May 2018), and achievement of it significantly derisks an investment.

So afterwards, IQAI could be a very attractive takeover target.
This could also partly be behind the big block buying that's been taking place.

To succeed though, I would think that an early bid would have to be at 20p or more, in order to get Trevor Brown and David Smith to agree to it.
TB holds nearly 30% of IQAI, and DS sold his last company for 178 million dollars (Tenaxix Medical, in 2014).

At just 4.55p, IQAI's massive advances over the last twelve months, e.g. the Cortechs deal, and the breakthrough on gadolinium-free imaging, have yet to be reflected in the share price, which has simply returned to its prior level.
And that's even before the upside from FDA approval for StoneChecker software, and the stream of positive newsflow that is likely to be unleashed by that.

Thanks for drawing our attention to these latest exchanges on the Imaging Biometrics Twitter account Degsy - that's bang tidy! -

Tony Heath @fastcar07 Jul 12
"Thinking stonechecker FDA extremely close now?"

Replying to @fastcar07 @proactive_UK
"Awaiting word from FDA...will update here as soon as we hear. Thank you!"
8:23 AM - 12 Jul 2019

Andy @Andy47640 Jul 19
Replying to @ImagingBiomet @fastcar07 @proactive_UK
"USA are a few hours behind the UK. #IQA ;)"

Aim Investor @Ahk910 Jul 19
Replying to @ImagingBiomet @fastcar07 @proactive_UK
"#iqai NEXT week could get let's just say could be folk scrambling for stock??
Most will get locked out prob get in at 10/12p as will GAP UP??
Early positions = #multibagger ?"

https://twitter.com/ImagingBiomet/status/1149448765511741440

I would think that the Imaging Biometrics Twitter account would announce the approval simultaneously with an IQAI RNS (probably already pre-prepared), unless it's after close of trading in London, in which case IB could announce it earlier, followed by a 7a.m. IQAI RNS the next day.

I would also think that quite a few American investors are following this stock, and for them, FDA approval will be viewed as of particular importance.

"No such trade went through"
"I'll believe my level 2 data over a member with 24 posts"

Nice apology Mibo - not.

And well done to Absolute & Kiwi.

This is the trade:
18-Jul-19 14:23:18 4.898 471,975 Buy* 4.40 4.70 23.11k O

That was obviously a buy - it is above the mid price at any time on the 18th. (Thursday).

One of the keys to successful investment is to distinguish between a brief spike, and a steady sustainable rerating upwards.

An example of the latter is Optibiotix Health (OPTI) ten-bagging in 2014-2015, from about 9p to nearly £1.
It's currently 74p (market cap. £63.2M.).

IQAI's has all the hallmarks of that type of rise, particularly ongoing big block buying, and buying into dips.

Though IQAI was starting from a much lower base, and at 4.8p. is still only at a similar market cap. to that which OPTI was starting from.

And 4.8p has just been a recovery to the level for most of H1 2018 and earlier, since when there has been massive progress.

Like OPTI's rerating though it doesn't happen overnight, and doesn't go up in a straight line.

We're only about a month and a week into the current rise, so it's still relatively early days.

From both a valuation and technical perspective, there is still massive upside.

Thanks Tidy - it's very encouraging that acyan are tweeting so positively about what we can offer.

IQAI has previously suggested that a CorTechs type of deal with acyan is possible, so acyan been bullish on our offering is a very positive sign in that regard.

Also note that IQAI actually names specific resellers, in its 30.4.19 RNS: i.e.:
" ... This work is already underway with a series of resellers such as aycan Medical Systems, QMENTA, Blackford and Medimsight. ..."

It's fairly unusual to name companies before deals are actually announced, and in my opinion the fact that IQAI does so supports the view that these companies are keen to work with IQAI, and that deals could be announced shortly.

Thanks for that excellent and useful research, Kiwi & Degsy.

I think they help to illustrate the tremendous market opportunities that IQAI are targeting.

The medium and long term technical analysis is very bullish, and this is a short-term pullback only.

Those traders who exited will doubtless be looking to reenter for the next leg up.

Strong consolidation at about the 6p level before the next leg up.

It rose from 5p on Friday, so the majority of the gains are in place.

Iain,

People have been calling the top here ever since this rise started a month ago, and have been consistently proven wrong.

That's because they don't understand what's happening here: a massively undervalued shares being rerated upwards to a fairer level, fuelled by consistent large block buying.

Any dips are bought into big time as buy opportunities.

P.S. I have probably spent more months looking into this share than you have minutes!

"Next major resistance 7.19p"

Drax,

In the face of FDA approval, 7.19p 'resistance' will be as about effective as a picket fence in the face of a tidal wave.