Renalytix Share Discussion Threads

[cambridgedon] 02/9/2020 16:39

MG1982 and others:
I'm with AJ Bell. Initially, they said exactly what you quoted. When I challenged this, quoting Halifax I think it was who had credited Verdici shares to a posters' account, they back-tracked and said they were awaiting details of the allotment and would show the shares in my account once details received.
Still haven't seen anything!
CD

[74tom] 02/9/2020 15:55

Cheers guys, appreciate the feedback - I'm the same MG, not bothered as I know they'll arrive at some point, just keen to not be the only one that hasn't received them.

[mg1982] 02/9/2020 12:17

74tom and others,

When I contacted HL they said:
"We are currently chasing the registrar for the new Verici shares. We hope that this is resolved shortly. We will contact you once the shares have been credited."

And AJBell said:
"I have read through the Corporate Action Event and can see that the shares are subject to a lockup period, after which we will receive the
outturn from CREST (the UK settlement system). Please see the text below:

'Verici shares will only be credited to your account following a lockup period. This period will last until:

· 365 days following admission to trading on AIM (or another recognised stock exchange) of all or part of the issued share capital of
Verici; or

· if all or part of the issued share capital of Verici is not admitted to trading on AIM (or another recognised stock exchange) within two
years of the date that the Distribution is declared, two years from the date that the Distribution is declared.'

Make of that what you will? As long as I get them as don't get told Oh sorry, I'm fairly relaxed

[toffeeman] 02/9/2020 12:13

Yes I am - AJ BEll

[peterc1970] 02/9/2020 12:06

I don't have them in my IG ISA or stockbroking account

[74tom] 02/9/2020 11:50

Nope, the MM's are all too keen to drop the price when NASDAQ falls below AIM (I.e. on the AZN news a couple of weeks back), but when it's the other way around they aren't interested. As I've stated before, I doubt this will remain dual listed for too long, the fact the CFO is going to be buying shares based on the ADS price is another clue that NASDAQ will be the only game in town at some point.

Ps. Anyone still waiting for their Verici shares?

[wiseacre] 02/9/2020 11:08

Good arbitrage on Nasdaq price. Aim stock does not reflect 8% rise in Nasdaq price over the past two days.

[wan] 01/9/2020 07:30

Dapagliflozin (Farxiga) is an AstraZenica drug. And the following might spur further pharma interest in repeat testing with KidneyIntelX and prediction of therapeutic response -

SGLT2 Inhibitor Wows in Chronic Kidney Disease
— DAPA-CKD shows fewer renal events, prolonged overall survival
by Crystal Phend, Senior Editor, MedPage Today August 30, 2020

In chronic kidney disease (CKD), dapagliflozin (Farxiga) reduced renal events and substantially improved overall survival, regardless of diabetes status, the DAPA-CKD trial showed.

Full story -

List of SGLT2 Inhibitors and manufacturers and side effects -

[wan] 01/9/2020 07:10

Most readers will recall that KidneyIntelX is already designated as a Breakthrough Device by the FDA, and the submission for marketing authorisation will receive a prioritised FDA review.

According to the following, Medicare coverage for KidneyIntelX may now arrive sooner -

CMS Proposes Quick Path to Medicare Coverage for FDA Breakthrough Devices
Aug 31, 2020

NEW YORK – The US Centers for Medicare and Medicaid Services on Monday issued a proposed rule that would provide more immediate federal payor coverage of medical devices given the US Food and Drug Administration's breakthrough designation.

The rule would create what CMS is calling the Medicare Coverage of Innovative Technology (MCIT) pathway, under which medical devices given FDA's breakthrough designation would, upon receiving FDA market authorization, be covered by Medicare, with that coverage continuing for four years.

The proposed rule will be submitted to the Federal Register on September 1, 2020, after which CMS will collect comments on the rule for 60 days.

Full story -

[sspurt] 28/8/2020 14:03

Finals next Thursday

[74tom] 27/8/2020 11:13

Agreed, think 40p is a record for RENX, positively it discourages traders and means that those who buy really believe in the prospects! Thanks for the info on approval timelines guys, all makes sense. September should bring the Mount Sinai launch (as per comments from N+1 yesterday), and surely Kantaro approval. Fingers crossed for some more partnerships akin to the AZN deal announced last week.

[wan] 26/8/2020 13:32

Given the Breakthrough Device program and designation etc, I think that is realistic.

[sspurt] 26/8/2020 12:51

N+1 Singer reckon approval likely by end of the year

[charlieej] 26/8/2020 08:57

I went to a results evening in London and James McCullough made a big deal over the difference in experience between FDA breakthrough device approval appreciation and a standard application. As I understood it the FDA effectively reviews the application before it is handed in, advising the company on what tweaks need so that it should be approved first time. Difficult to know how long approval will take though with FDA working on EUAs for corona associated products. Flip side to that is it works in RENX favour with the Kantaro test.

[wan] 26/8/2020 08:44

74tom...(thanks) That's a difficult one. First of all, it's worth bearing in mind that Breakthrough Designation means that the FDA has already established that KidneyIntelX provides for more effective treatment and/or diagnosis for kidney disease.

But it's also worth keeping firmly in mind that Renalytix has been working with the FDA towards the goal of FDA submission 'since' the Breakthrough Designation in May 2019. In other words, the FDA has also provided a lot of guidance and support, and from my understanding, this is provided by a dedicated FDA review team, which was part of the Breakthrough Device Program.

[74tom] 26/8/2020 07:55

Hi Wan, link fixed :) Yes more solid progress along the path to commercialisation, what would be your estimate on FDA approval timeframe?

[wan] 26/8/2020 07:29

Good morning 74tom. That last link you provided appears to be distorting the thread width, if you cut and paste it into the following link it will shorten it and should resolve it when you paste the new link back in.

Today's RNS of FDA 510(k) submission is welcome news and because KidneyIntelX is already designated as Breakthrough Device by the FDA, the submission will receive a prioritised FDA review.

[74tom] 24/8/2020 11:18

Spot on analysis, just to add a little bit more after I've done some research;

Page 3 of the FDA release states that only the Ortho antibody test can currently be used to certify high titer. But as you say the measurement is simply a comparison against a benchmarked antibody titer level, rather than a specific value.

"Units tested by the Ortho VITROS SARS-CoV-2 IgG test and found to have a signal-to-cutoff (S/C) value of 12 or greater qualify as high titer COVID-19 convalescent plasma."

With the Kantaro test giving you the an exact antibody number, rather than simply a yes / no as to whether you exceed a cutoff point, it's clearly a significant incremental improvement vs the Ortho test.

I can't see any reason Kantaro wouldn't receive EUA approval, particularly as it can be manufactured at scale and run on any ELISA capable machine in the US / world.

Ortho can only be run on it's VITROS platform that's currently installed in 1000 hospitals in the US :

Also found an interesting evaluation of the ORTHO test by Public Health England that appears to contradict it's claim of 100% specificity:



"In this evaluation, the sensitivity of the VITROS Anti-SARS-CoV-2 Total assay
increased was 91.8% (95%CI 83.8-96.6) for samples collected ≥14 post symptom onset
and 93.5% (95%CI 85.5-97.9) for samples collected ≥21 days post symptom onset. For
all samples, the sensitivity was 85.0% (95%CI 76.5-91.4). The manufacturer reported a sensitivity of 100% (95%CI 79.4-100) for samples ≤8 days and a sensitivity of 100% (95%CI 92.7-100) for samples taken >8 days’ post symptom onset."

Given the fanfare that accompanied last night's announcement, it makes you wonder whether the Kantaro test might receive something similar - certainly the superlatives used by the Bio-Techne CEO on the earnings call earlier this month suggest it's game changing...

[wan] 24/8/2020 07:44

An FDA EUA issued yesterday where the qualification of the titer is fundamental, is likely to be positive for Mount Sinai efforts and of course Kantaro's RUO test, in terms of the scientific weight that must now be building around the use of antibody-rich blood plasma to treat coronavirus patients.

23rd August 2020
Criteria for Issuance of Authorization
I have concluded that the emergency use of COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19 when administered as described in the Scope of Authorization (Section II) meet the criteria for issuance of an authorization under Section 564(c) of the Act


Mount Sinai has been using blood plasma since March, and as of June the test had been utilised over 50,000 times -


Ultimately, this appears to bode well indeed, as Kantaro’s kit reports the amount of titer found in the bloodstream in addition to a positive/negative determination, enabling a more accurate understanding of antibody presence.

[nimbo1] 24/8/2020 07:32

It depends which platform you use. I have interactive broker for international stocks and it’s far less to deal them than the HL transaction fees for Uk shares as an example.

[homebrewruss] 24/8/2020 06:41

Thanks mf and toffee

[toffeeman] 23/8/2020 22:43

If you are buying shares, the transaction costs of buying US stocks are considerably higher than buying the UK versions. So if both are available buy UK.

If you are spread betting - it doesn't matter because of the XR.

[mad foetus] 23/8/2020 20:36

The spread on the US listing can go very wide. But liquidity should be better - IG could only give me a £5/pp bet at 8.04 on Friday