The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
Spinouts have commenced* (from end of previous post)
SGS getting near to having their own facility completed - any issues?
No issue with SGS at the moment, their core staff are with ORPH now, SGS are in their early stages with fewer beds than ORPH, SGS could be “useful” and “a friendly party”
What stake in POLB does the new CEO have?
CF has < 2% in POLB, small stake put together for management team
ORPH shares held in CFDs before the POLB qualifying date, what happens to spinoffs?
CFD provider will get spinoff shares, need to talk to your advisers - anyone who held on date will have got shares
Is Imutex vaccine technology being superseded by newer vaccine tech?
CF very frustrated with Imutex divestment and lack of action from ConserV. “Huge huge growth” potential from Imutex technology, Imutex “is crying out for it”
Full control of 2 or 3 spinouts, has running order changed?
Some of our partners don’t move as fast as we do. Let’s get the rest done and done fast
Some cash used for bolt on acquisitions - any details?
Always looking for small purchases as we are in expansion mode, watch this space
What’s the forecast timeframe to get SP back to 40p?
Let’s see how we go, distressed shareholder now gone, company profitable, SP will rise nicely
Comment on recent SAGE minutes?
Original minutes were published that didn’t include extension, extension is underway and will complete in the Autumn
Expansion plans in place?
A lot of plans, a lot of new challenge studies coming through, company has multiple facilities now, we can roll out additional bed capacity as required
Cost of closing clinics?
No plans to close any clinics so we won’t have these costs. More or less fully booked but can occasionally find small gaps, looking for fourth premises
Previous presentation - five flu studies lined up but only one announced?
Flu is our bread and butter along with RSV and now malaria
When will Covid characterisation complete and when can we sign contracts?
Will complete this autumn
Will ORPH be doing the Phase II trial for Codagenix?
Can’t say too much as information is commercially sensitive but we can expect more work from Codagenix
Do ORPH have continued access to RF after Covid study?
No rent paid, great facility to have, let’s see what happens with Covid study - some of £37m from government goes direct to RF
How much was ORPH paid for covid challenge work?
A Significant sum
When are CHIMs for Covid commencing?
Royal Free is geared up for all these studies, we don’t pay rent but won’t happen until characterisation complete in Autumn
Oxford doing reinfection study - are they using Hvivo CHIM for this?
Yes they had to use Hvivo as we are the only people who can do it
If ORPH isn’t bought out, what is the vision for the company (including market cap) and for the non-core assets?
ORPH is “ a hell of a place to be”, CF is quite excited, non-cores will be spun out which will allow us to continue being market leader and growing the core business. This will make ORPH even more attractive to buyers
Is it acceptable that over-optimistic claims in the past haven’t materialised?
CF is tempering his enthusiasm, he has been over optimistic on timelines but business case hasn’t changed, very few AIM companies as attractive as ORPH
Can you update your top shareholders page?
Can’t publish names unless 3%+, see Bloomberg for details on institutions
Company has lost positive sentiment - thoughts on this?
Perfect storm at the end of June, major seller dumping substantial number of shares, Tony R was blamed but he only sold a small portion of his stake, the other seller sold more. Overhang cleared last week, “this is the start of the fightback” in the share price. Newsflow “cranked up” from today to “get some life back into the share”
CF was in Antwerp around a month ago - expansion plans?
Let’s watch this space in Antwerp and Benelux - something positive coming in the next month or two
Any IIs still in ORPH and are they selling down in a disorderly way?
Between now and Xmas a lot of new challenge studies RNS’d, wouldn’t have been good to announce contracts when there is a big seller anyway
What is deterring big investors and what are you doing about it?
Engaging with them
Original ORPH plan to sell data to pharmas?
Wrapped up in DIM, work in progress, needed to prove the model and spinouts have comm
Still on track for cash dividend at Xmas?
We are targeting this, profitable service companies always pay dividends
Half year results in September? Should we expect slim profits?
No, the company has decent profits. FIrst half results at the end of September.
If you claim ORPH market cap should command 8x revenue as it is number one in its space, do we need hard numbers for revenue?
End of september for revenue figures
Share buyback was approved in AGM - how much cash will be allocated and why has SP not been used to clear sellers?
It is an option
Do you envisage a solid bottom line for this year?
Absolutely
How is cash balance looking currently?
Stabilised around £15m and should be growing
Rapid growth of business and delay between major reports, will you do trading updates?
Yes end of September, will eliminate some confusion
Unexpected rise in costs in 2020 results - can you explain?
YoY costs increased because of merging companies, costs are not out of control
One or two spinouts by the end of April was originally mooted - where’s the other one?
First one done, rest are work in progress, “we’ve got them into shape and they are underway, that’s all I can say”
What is ongoing relationship with POLB in drug development?
Covered earlier, sharing staff, reducing overheads, only one new member of staff which is CEO Jeremy
CF appointed non-exec chairman of POLB, previously mentioned leadership role in DIM - still the case?
ORPH may get CEO later this year, CF cannot be CEO of DIM and other companies
What is the reason for the 9 month lock up for POLB?
Virtually 100% of POLB returned to shareholders, lock up period to allow SP to grow as we approach Nasdaq listing, may end lock up early depending on SP growth
Every time a non-core asset divested will value of ORPH decrease?
No, people think divestment of POLB was dilutive but this was not the case, value decreased because of seller and other reasons
How much is ORPH charging POLB for licensing?
There is a charge; we have in place a commercial, arms-length agreement for licensing some data
PrepPharma - rumours of Nasdaq listing? True?
Any listing, if they go to Nasdaq, must also have a dual listing, either AIM or elsewhere in London
What solid plans does ConserV have for Flu-v?
We’ve been disappointed with ConserV but we will update the market in a week or two, we will be doing this ourselves. Can’t understand why this hasn’t been done in the current boom time. ConserV is Seek rebranding themselves
Imutex - what’s going on?
See above, bear with us for a couple of weeks
How much will be raised in the DIM IPO?
Less than POLB, DIM doesn’t need a lot of cash, 100% owned by ORPH from day one, with HMRC approval therefore tax neutral, but will be a small fundraise
Ongoing discussions with china?
Yes ongoing, work in progress, China are very interested in vaccines and CHIMs
Made a few notes as CF was presenting just now. Didn't note down everything as some of it has been covered before or was covered more than once this evening. Please add anything I missed or got wrong, had some trouble keeping up with the detail at times.
Main presentation
- Overhang created by a legacy seller post-lockup now cleared - nearly 8m cleared
- TR sold 2.5m but has agreed to hold remaining c.14m until end of next summer
- ORPH confirmed profitable and likely "firmly profitable" for all of 2021
- Imutex “could” be put into a separate business, Prep “could” follow the same plan as Imutex, DIM we “hope to copy what we did with Poolbeg”
- None of the spinoffs with be dilutive to number of ORPH shares in issue
- 1 - 2 malaria studies in 2021 and 3 - 4 next year
- “Covid characterisation study taking a little longer like everything in this business” (!)
- POLB sharing office space and other overheads with ORPH and can commission challenge studies and other work from ORPH, meaning POLB is synergistic rather than dilutive
- ORPH will be taking control of Imutex divestment process imminently, can’t wait for ConserV any longer, process “well under way”
- Cash balance down c. £4m between Dec 2020 and May 2021 - some cash used preparing non-core businesses for spinouts, wearables project and new challenge models; some cash may be used for ‘bolt on acquisitions’ as company is in expansion mode ‘in a significant way’
- Half year results in September but confirmed EBITDA profitable in H1
Questions
Covid is 20% of company - is this in terms of resources or cash generation? What is remaining 80%?
- ORPH is not a pure Covid stock. 15 - 20% of total revenue last year from Covid, rest of business bringing in tens of millions
Cash balance - will there be a drain for each spinout and no cash remaining at year end?
- Absolutely not, we are maintaining that cash. Some spent on POLB preparation, some spent on other spinouts prep, some on malaria challenge model. Cash balance should be growing for remainder of the year, company won’t run out of cash. “Next to no further cash required for spinouts”
Can you be more specific re: UK gov challenge study starting?
- Has been an extension, CF tries to move things faster than they can go. Complete by autumn
No TR1 but SP has fallen dramatically?
-“Somewhat difficult” shareholder who reached end of lock up period was below 3% so no need for TR1, same as Tony Richardson but he has stopped selling for now. Positive newsflow incoming should see share price respond accordingly
Post spinouts, ORPH likely to be an attractive takeover opportunity. Do you want to grow the company or sell, and at what price if you want to sell?
- Would sell for the right price, company is number one in its field so there’s no rush to sell at the wrong price. CF wouldn’t buy at 26p if value wasn’t going to increase
Still on track for cash dividend at Xmas?
-We are targeting this, profi
Just published by the Telegraph. Amazed to see the opposition doing some 'opposing'.
https://www.telegraph.co.uk/politics/2021/07/21/boris-johnson-faces-commons-defeat-vaccine-passports/
The Labour spokesman said: "We need to see the detail of what the Government puts forward regarding vaccine passports. We oppose the use of Covid vaccination status for everyday access to venues and services. It's costly, open to fraud and is impractical.
"Being double jabbed doesn't prove you aren't carrying the virus. Testing for access to venues would be more efficient, and would give people and businesses more certainty."
Had this fairly generic reply from HSBC about POLB, guess it's just a waiting game.
"Thank you for your message dated 13 July 2021. Our Corporate Actions team confirmed the following - For Open Orphan, generally around the ex date, they receive payments/shares etc, the ex date was 18 June 2021, as yet, they have not received a confirmation date as to when they should expect to receive new shares or payment for this event. They shall endeavour to apply this to your account as soon as possible."
CF could have put £300k of his own money into any other AIM or FTSE company too, but he didn't.
Not a very long interview, CF is speaking for less than 10 mins so quite a quick listen: https://www.**********.co.uk/articles/open-orphan-john-meyer-glen-goodman-ce297e2/
Made some brief notes:
Intro to ORPH
- world's largest and leading tester of vaccines and antivirals, "very profitable, London based and having a really good time" - we have exciting plans as we emerge from the pandemic with many existing challenge models and new ones coming online
- New contracts this morning - some contracts take longer to finalise, aware some investors are getting nervous
- First new contract is for influenza/HRV from American company - contract size not disclosed due to commercial sensitivity but expecting more contracts of this type
- Covid contract at Royal Free extended, 'Covid hasn't gone away, exciting to see extension to this contract'
Questions
Small cap and micro cap space has seen sell off recently, ORPH no exception, but you've made substantial new investment today?
- Yes, we've been moving very fast, had a great run before falling back. CF wanted to buy weeks ago after accounts published but couldn't when contracts were outstanding, now able to do so, CF thinks ORPH is a fabulous buying opportunity. No need to panic, bear with us and ORPH will be in great shape in coming weeks and months
Why is sell off happening apart from general market malaise? Selling ORPH to buy POLB?
- Yes absolutely, we are delivering spinoffs, we've spun off first asset which will IPO imminently, ORPH has gone ex dividend so share price drops by the corresponding amount. We want to double or triple POLB share price in fairly short space of time. ORPH shareholders have 'free' shares in POLB but some shareholders are selling ORPH to buy more
Was H1 profitable?
- "Absolutely", see nomad statement in the director dealings RNS that ORPH was EBIDTA profitable in H1, we're "really happy"
Bullish for the rest of the year?
- "Yes, really bullish", three more spinoffs to come, DIM is the one to watch, will be spun off in Autumn, aiming to put it into another public vehicle. "Getting the baseball bat out" for Imutex progress! Prep Bio mentioned briefly but no specifics other than all four non-core assets spun out by Xmas and returned to shareholders with dividends in specie
Three quick reasons why an investor should add ORPH to their watchlist?
- Current share price is fabulous buying opportunity, CF has bought some more himself today, a bunch more spinouts to come, no reason why recent POLB spinoff can't be replicated for other non-core assets before Xmas, and the management team is very much invested and still at early stages - management are looking to increase stake(s) rather than sell out
Not that it really matters if you're not looking to sell any time soon, but he definitely says bear with us for "days, not weeks" at the end of the results presentation.
News could drop at any time now, a showstopping Monday intraday RNS would be a delightful start to the week!
When do you expect to pay first cash dividend?
- Shareholder and court approval to pay dividend has been obtained. Part of cash balance has been allocated
Will we see any other director dealings in ORPH shares?
- CF can’t speak for others
How can SP drop on ex dividend when we don’t know value of dividend in specie?
- Guesswork on value, more astute investors are guessing. SP usually drops pro rata based on expected value. A lot of appetite for these assets
Will we receive cut off dates in advance for all spin offs?
- Yes
CROs valued at 6x revenue?
- Most CROs are 4x – 5x, Ergomed is most comparable to ORPH and they’re at 8x revenue. ORPH should be valued more than typical CRO due to high moat and major investment in the business(es) over past few years
Any DIM contracts signed?
- Quite an amount of interest in data but as company will be spun out, this will be completed first before contracts are signed – “messy” otherwise
If I buy more ORPH shares will I get more shares in spinouts?
- Too late for Poolbeg now but yes for remaining spinouts
Final word – yes we are disappointed in share price dropping, however company is cash generative, ORPH will never be fundraising, likely cash dividend before Christmas. Bear with us over next “days, not weeks”, we’ll be in a much better position. “Upwards and onwards from here”. May do investor forum once a month so CF and team can be held accountable.
No. of ORPH new company registrations and name changes is confusing – can we have an organisational chart to clarify this?
- Bit of experimentation in this process to work out best structure, especially regarding tax minimisation. Poolbeg is name of first spinout, forget other possible names. DIM will be second spinout
Could ORPH follow up with an “idiot’s guide” to non-core assets?
- Roadshow in next couple of weeks for Poolbeg, more detail on valuation to follow that. Half the book already covered due to level of interest
When is cutoff date for Poolbeg shares?
- Cut off date was yesterday (16th June). CF expects retrace in ORPH share price commensurate with value of assets that have been spun off
DIM – will this be spun out as its own company?
- Yes absolute, three to four months from now
DIM on track for completion by end of year?
- Much sooner than that as ORPH has 100% control. Will be spun out but “not saying it will IPO”. Shareholders will get shares in that vehicle. Spinouts can’t be subsidiary owned by ORPH, CF and Ian O’Connell will end up with “a couple of percent” stake each, locked up for two years. CF putting up to £500k of his own cash into Poolbeg too at market price, again with two year lock up.
Questions on 2020 final results were skimmed over as mostly covered in earlier presentation, but I did catch that salary costs have increased £5m to £15m following Hvivo acquisition but 50 heads were ‘cut’ prior to this.
Is characterisation study complete and when can we expect first CHIM contract?
- Completion taking a little longer, “virtually complete” and then we can sign off on first big CHIM contracts
Following analyst meeting do you think they’re on your side?
- Don’t want to be unfair to analysts, they are forecasting £50m and £7 – 8m profit, we are aiming to substantially exceed that, CF will be unhappy if ORPH doesn’t exceed that
What is basis of spinout valuation?
- Already covered, 10 – 20% of mcap, which will rapidly increase
More granular trajectory on revenues and how you’re counting receivables?
- Don’t do multiyear contracts, money upfront right away, 15 – 20% on signing delivered within 3, 6 or 9 months. Revenue recognition is in the year we sign the contract
If new shares are in ISA there won’t be CGT?
- Correct, totally tax neutral
Any developments on testing of antivirals?
‘- Let’s watch, news soon’
Any news on Chinese pharmas?
- Absolutely, deals take time, important to get this right. China’s vaccine diplomacy efforts mean they need ORPH’s services
DIM – patented? Trademarked?
- Yes, also some biomarkers trademarked
All spinouts will create dilution – what do you expect ORPH SP to be after all spinouts?
- All competitors trade at 6x revenue without spinouts. ORPH unique, has a high moat, CF thinks company is undervalued. “Bear with us a couple of weeks and we’ll all be in a very different place”.
Financials
- 2020 transformational year for ORPH in terms of mergers and restructuring plus removing ‘excess’ management
- Major contract wins in 2020 compared to previous year
- Business is well capitalised with strong cash balance - £19m at end of 2020 compared to £1m at start of year
- Numbers presented in accounts slightly misleading, “not comparing like for like” – 2019 numbers reflected Venn and OO on standalone basis for 2019, whereas 2020 reflects those two companies plus Hvivo
- Modest drop in revenue year on year due to some Covid impact plus divesting clinical operations in Europe
- Q4 EBITDA of £1.3m vs £7.9m loss for previous three quarters combined
- Challenge / Lab contract wins at £27.1m in 2020 compared to £3.9m in 2019; already at £15.4m for current point in H1 2021 with further material contract win expected imminently
- Outlook – strong pipeline of contracts, new challenge study models live soon, targeting FY profitability in 2021, demergers progressing well
- 20 – 30% growth “minimum target” in 2022; still lots of work to do but confident in direction
Questions
Disappointed in share price today?
- Of course, but CF very committed to increase shareholding as very confident in ORPH’s future (“a bloody good opportunity”), wanted to do today but inside information prevented this – watch this space
Detail on expected value of dividend in specie for Poolbeg?
- In the region of 10 – 20% of current market cap. Shares to be held in trust and untradeable for nine months. Expecting a double or triple of the value of Poolbeg in that time. A lot of newsflow expected, stick around for a long time and the Nasdaq listing and rewards will be good. “Let’s see how big we can make Poolbeg.”
CGT implications in Ireland? (I couldn’t make out the full wording of this question)
- UK HMRC prior approval, statutory demerger for assets you already own so no tax implications initially. CGT will apply if you sell for profit further down the line.
Poolbeg shares released after lock in period, will we get share certificates directly or to brokers who hold the shares?
- Directly to wherever your ORPH shares are held – broker account, ISA account etc but will be done via Crest system to existing account
Directors can buy shares on open market, no options for directors?
- No, CF not a fan of options, too many historical options from Venn and Hvivo. CF is buying with his own money, “a substantial investment”
Timeline of spinouts?
- Poolbeg underway, roadshow next week, IPO within three weeks. DIM under ORPH’s control also, process underway, couple of months timeframe for this, 10 – 20% of mcap as guidance. PrepBio not completely under ORPH’s control and it does take time to do deals with pharmas. Reiterated again that all spinouts will be done via statutory demerger by Autumn.
Pretty good presentation I thought, definitely reassuring after watching the share price battle to remain above 30 yesterday and nice to see at least a bit of recovery today.
Pleased to get more detail on the 'other assets' CF has mentioned previously that have gone into Poolbeg and get some rough figures and projections for the valuation. Intrigued by the new insider information that has come to light too, and we'll have to only wait days rather than weeks to find out more.
Some notes I made as I was listening:
Introduction
- “no question” ORPH is now profitable
- CF was hoping to buy shares today (now yesterday) but more insider info has come to light, should be made public in next few days and CF will be able to buy shares following that, he’ll be “putting his money where his mouth is”
- Infectious diseases currently a 10bn industry, forecast to grow to 250bn annually by 2025 – single biggest market ever in pharmaceuticals – vaccines, antivirals etc. for flu, RSV and so on; ORPH clearly a leader in this area
- Watch this space for £10m+ deals – ‘those who stick around will be rewarded’
- DIM now patented, will be spun off, it’ll be an IPO, shares will be distributed via statutory demerger with HMRC approval as with Poolbeg – no tax to pay as we the shareholders already own the asset(s)
- Monetising all non-core assets and they’ll be done by the Autumn, “that is a hard stop” – CF doesn’t want to hang about with non-core assets because ORPH needs to focus on services offering. Later repeated this Autumn deadline.
- First Poolbeg asset may be competing with products of ORPH’s clients – makes sense and keeps clients happy to divest these
- Cash balance has dipped as some money has gone into non-core assets
- DIM data has application for big tech, wearables, pharma and biotech – “data is the future”, process for spin out “well underway”
- Good to see some more detail about what has gone into Poolbeg – a P2-ready immune modulator for influenza (which stops cytokine storm so may have application for long Covid) as we already knew, plus a data-based Vaccine Discovery Platform, “PredictViral Biomarker” platform for predicting severe disease, and non-exclusive licensed access to ORPH’s huge database with advanced discussions underway for this
- PrepBio – ORPH “cracking the whip” re: divestment
- Imutex process “well underway” but no more specific detail unfortunately, CF getting frustrated with delays here
Haha I'm touched! I was out all day and evening yesterday so haven't watched the presentation yet, looks like a bit of a bounce in the share price off the back of it though. Planning to watch it later this morning if I have time.
"As part of contracts with the government worth around £3 billion, Innova has supplied more than one billion tests to the UK."
https://www.independent.co.uk/independentpremium/covid-rapid-test-innova-latest-b1856023.html?r=53792
Can't be precise based on those figures but over 1bn supplied at around £3 each.
She was critical of the fact that the Innova test is still “being used as a 'test to enable' which is not what the special permission allows”.
A DHSC spokesperson said: “Around one in three people with Covid-19 experience no symptoms, so regular, rapid testing detects cases that wouldn’t have otherwise been found, breaking chains of transmission, including variants of concern.
“Testing is a vital tool as society reopens and anyone who uses an LFD test should report their result, whether it is positive or negative, within 24 hours on the gov.uk website.
“Every test used in the national testing programme has undergone rigorous clinical evaluation.”
Innova said it was unable to comment on its contract with the DHSC. It said its test is very good at picking up those who are most infectious and therefore tackling the spread of Covid.
Academic advocates say the tests are highly accurate, are fast to deliver results and serve as a vital public health component.
It's a pretty long article, here's the rest with some more detail:
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An EUA provides short-term (typically six months) authorisation for a product while normal regulatory approval, such as a CE or UKCA marking, is pursued.
Under the initial approval granted in December, the MHRA said the emergency authorisation would come to an end on 22 June, or when the device is CE marked – meaning it meets EU standards for health products.
Graeme Tunbridge, MHRA director of devices, said the Innova test was not yet CE marked. He also confirmed to The Independent that the medicines regulator is “reviewing an application for the extension of an Exceptional Use Authorisation in relation to tests issued by NHS Test and Trace.”
While there are other CE marked self-tests available in the UK, these may not be aligned with the government’s specification for use in asymptomatic people as part of Test and Trace.
No 10 will be hoping that the regulator provides a green light for the continued use of the Innova devices after the US firm announced last week that a factory in Wales is soon set to begin producing millions of its tests a day.
Dan Elliott, chief executive of Innova, told the Financial Times the company was “making large investments into the UK”.
A number of manufacturers are used alongside Innova to provide the public with rapid lateral flow devices (LFDs) that can be used at home and which return a result in as little as 30 minutes.
People are encouraged to take two tests a week as part of the government’s plans to reopen society, alongside the vaccine programme.
However, scientists remain divided over the widespread use of LFDs, which are far less accurate than the laboratory-based PCR tests.
Analysis has shown the LFDs correctly identify, on average, 72 per cent of people who are infected with the virus and have symptoms. In those without symptoms, this figure drops to 58 per cent. But limited data makes it hard to draw firm conclusions, while accuracy varies between the different brands of LFDs.
Use of rapid tests in the UK has also dropped by 16.4 per cent over the past month, according to the latest Test and Trace data.
Between 15 April and 26 May, there has been a 951,174 fall in the weekly number of used lateral flow tests registered by members of the public – down from 5,772,872 to 4,821,698.
Those who test positive using a LFD are expected to confirm their result using the more accurate PCR test.
Dr Angela Raffle, a public health consultant at Bristol University, said it was “inevitable” that test fatigue is setting in. “Even in the first two weeks of school testing when infection rates were higher and people would have taken it more seriously, it took nearly 7,000 tests to find one positive,” she said.
“And many people are very busy with work, childcare, etc, and the time to perform a test and log the result is not insignificant.”
Haven't really been keeping up with the board today, apologies if already posted. Sounds like the UK Gov is potentially looking for a new LFT supplier.
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https://www.independent.co.uk/independentpremium/covid-rapid-test-innova-latest-b1856023.html
Multi-billion contract on the line as UK regulator reviews rapid testing device for continued use
Special authorisation for use of the Innova lateral flow test, which currently expires on 22 June, is being reviewed by Medicines and Healthcare products Regulatory Agency, finds Samuel Lovett
A multi-billion contract the government signed with a US-based diagnostic firm could be in jeopardy if Britain’s medicines regulators does not renew its special authorisation of one of the most widely-used rapid home tests in the UK.
The Innova lateral flow test was first approved by the Medicines and Healthcare products Regulatory Agency (MHRA) back in December – but only under a time sensitive Emergency Use Authorisation (EUA) that expires on 22 June.
As part of contracts with the government worth around £3 billion, Innova has supplied more than one billion tests to the UK, which are being used as part of Downing Street’s twice-weekly mass testing programme – a crucial pillar of NHS Test and Trace.
However, the tests have been plagued by controversy. Fears have been raised that the devices are not sensitive enough and may incorrectly inform infected people that they do not have the virus, encouraging them to lower their guard and contribute to onward transmission.
The MHRA also reportedly expressed its concern with the Department of Health and Social Care (DHSC) that the mass testing programme unveiled by the government in April was “a stretch” of its authorisation for how the devices should be used.
It told DHSC in December that “we do not currently support” use of the device as “a ‘test to enable’ function” – in essence, one that would allow people greater freedoms if they returned a negative result.
However, according to the Guardian, the MHRA was worried that Downing Street did not make clear that the devices should only be used as a “red light” test to detect infectious people and order them to isolate.
Amid these blurred lines, and with limited data on how well the tests perform when taken by people who do not have Covid symptoms, the MHRA is now reviewing its emergency approval of the Innova device.
The test’s EUA was granted on 23 December and is due to expire this month. In a letter sent from the MHRA to the DHSC, and seen by The Independent, the medicines regulator said the device will be “reviewed” if there “continues to be a need for a further authorisation”.
“A decision [will be] taken on whether it remains in the interests of the protection of health for a further authorisation or an amendment to this authorisation to be made,” the letter read.
The delays in the Imutex are especially frustrating I think, if I remember rightly July 2020 was the first timeframe mooted for news on this and now we're almost a year on.
Surely Seek/ConserV want to get Flu-v funded and into Phase III as much as anyone, I can't understand why they're holding up the process to the point where CF is publicly asking them 'what the hell they're doing'.
I'm sitting at home wondering what the share price will be at 8.01am!
Cheers all, glad the notes are useful.