It had been given a slight funding increase of £8m to pay for its role in establishing chemicals regulation ahead of Brexit and for helping to set up the new building-safety regulator led by Dame Judith Hackitt, before the new body becomes an independent organisation. A few hours after Johnson spoke in May, setting out the HSE’s central role in checking COVID-secure workplaces, the Department for Work and Pensions (DWP) announced in a press release that the government had made “up to an extra £14m” available for the organisation “for extra call-centre employees, inspectors and equipment if needed”. Clancy says: “We’re absolutely convinced it was the prime minister’s comments at the dispatch box that drove activity, energy, suddenly into the HSE’s capacity.” He adds: “The prime minister couldn’t make good on the spot checks without some sort of injection of resourcing and energy.” But he also argues that the money provided amounted to a “sticking plaster” in the wake of past cuts and that responsibility for HSE shortfalls lies with government rather than the organisation’s management. As the country locked down at the end of March, and HSE inspectors stopped going out to routine inspections to minimise contact between people, its policy was to physically attend sites only when called out to serious incidents. By contrast, much of the construction industry remained open at the time, prompting the kind of negative sentiments expressed in the CN survey outlined above. However, after Johnson’s comments in May, proactive inspections of construction sites and other workplaces restarted. Despite that resumption, there has still been a distinct lack of public engagement from the HSE over the past year, according to British Safety Council chairman Lawrence Waterman, who led on construction health and safety for the 2012 Olympics and is now a consultant at Park Health & Safety Partnership. He calls the situation “astounding”. “This is the biggest health crisis in my lifetime, worse than asbestos. Construction workers are ticking almost all of the at-risk boxes […] and the HSE is invisible; I’m amazed.” Waterman adds that the grim daily tallies of deaths and hospitalisations tell their own story: “What the government has been doing, including what HSE has been doing, is not yet good enough.” Clancy’s claim that the prime minister’s comments are what drove a sudden wave of activity at the organisation is further supported by a letter, seen by CN, that was sent to more than 200 former HSE inspectors a few weeks after Johnson’s announcement, in July. It asked them to consider returning to work for the regulator, via an agency, until the end of the financial year. In the letter, HSE director of regulation Philip White wrote: “You may be aware that, on 11 May, the prime minister announced in the House of Commons that HSE would be carrying out ‘spot checks’ to ensure worker safety and build public confidence. “The pressure to deliver ‘COVID-secure’ regulatory work is enormous. This pressure is not only from ministers and MPs but key stakeholders including the HSE board and trades unions. We have seen a huge increase in […] official correspondence and media queries asking questions on visit numbers and enforcement. “Delivery of spot checks started immediately following the [prime minister’s] announcement and visiting staff now inspect for COVID compliance at all sites they attend, regardless of the reason for the visit. A call-centre operation to deliver thousands of telephone-based COVID checks of businesses has also been initiated.” Despite the appeal, which went to 208 trained and experienced former inspectors, just 10 opted to take on the work, failing to deliver a meaningful boost to the watchdog’s capacity. Over the summer, the HSE sought to make good on the prime minister’s promise to ensure COVID-secure workplaces. An HSE spokesperson told CN it was “now HSE’s top priority” and it spent a substantial chunk of its £14m extra funding on a new call-centre operation to handle reports of COVID breaches and to phone businesses to ask about compliance.https://www.constructionnews.co.uk/health-and-safety/the-hse-in-the-pandemic-astoundingly-invisible-or-making-a-difference-26-01-2021/
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B. Riley analyst Andrew D’Silva thinks the FDA’s recent actions bode well for the drug's chances of approval. "CRMD was granted priority review for the candidate, which reduced the FDA's review time of the submission from ~10 months to ~6 months, and the FDA subsequently determined an AdCom meeting was not needed. As a result, we are increasing the probability of success related to an FDA approval from 70% to 85%, which is in line with typical approval rates seen for candidates once an NDA/BLA have been submitted," D’Silva commented. Taking onto account the candidate’s Phase 3 study results, in which the treatment showed a statistically meaningful drop of 71% in CRBSI in patients undergoing hemodialysis compared to heparin, D’Silva thinks Defencath could save the healthcare system around $1 billion a year. This is without even taking into account the “benefits related to reduced antibiotic use, improved quality of life, reduced mortality, or a willingness-to-pay (WTP) per quality-adjusted life year (QALY) gained.” D’Silva’s calculations lead him to believe Cormedix’ TAM (total addressable market) for hemodialysis is in the region of $1.7 billion. In line with his optimistic approach, D’Silva rates CRMD an Outperform (i.e. Buy) along with a $25 price target. Should his thesis play out, a potential gain of 75% could be in the cards. (To watch D’Silva’s track record, click here) Overall, CRMD shares get a unanimous thumbs up, with 4 Buys backing the stock’s Strong Buy consensus rating. Shares sell for $14.30, and the average price target of $22 suggests an upside potential of ~54% from that level. (See CRMD stock analysis on TipRanks) Kiniksa Pharmaceuticals (KNSA) Next up, we have Kiniksa Pharmaceuticals, and unlike Cormedix, the company has a varied pipeline of drugs in different stage of progress - all focusing on weakening diseases with significant unmet medical need. The upcoming catalyst for Kiniksa is the March 21 PDUFA date for rilonacept, for the treatment of recurrent pericarditis (RP), an agonizing and debilitating autoinflammatory cardiovascular disease. The FDA has granted both orphan drug and breakthrough therapy status for the treatment which showed positive topline results in the Phase 3 study. With roughly 40,000 patients with RP in the U.S. either looking for or undergoing medical treatment, Kiniksa’s focus is on bringing to market a treatment that not only addresses the symptoms of a pericarditis recurrence but also lowers the probability of future recurrences. Among the fans is Wedbush analyst David Nierengarten, who believes the company has the right approach.https://finance.yahoo.com/news/shockwave-medical-reports-fourth-quarter-210500572.html