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The Institute of Internal Auditors is pushing back against part of a proposed new standard on audit confirmations from the Public Company Accounting Oversight Board, saying it would jeopardize the traditional relationship between internal and external auditors and criticizing the implication that internal auditors are untrustworthy.
IIA president and CEO Anthony Pugliese sent a comment letter Friday to the PCAOB acknowledging that "although the recommended policy change minimally impacts the provision of internal audit services, it represents a significant departure from the regulatory status quo regarding the relationship between internal and external auditors."
The IIA is objecting to a section of the PCAOB's proposed confirmation standard that states, "Involving internal auditors or other company employees in these activities would create a risk that information exchanged between the auditor and the confirming party is intercepted and altered."
He believes that implies internal auditors are "untrustworthy or incapable of exhibiting due care in the performance of their duties."
Pugliese also objected to comments in a Wall Street Journal article in which unnamed PCAOB officials were cited as saying that the goal of the proposed standard is "to make sure that internal auditors don't manipulate the confirmation requests before they go out or the responses after they come back."
Pugliese denounced that characterization as "false and inflammatory" and "completely unwarranted."
The PCAOB proposed the standard in December, replacing an interim standard that hasn't changed for two decades. The proposed auditing standard would take into account advances in auditing technology, but would apply to all methods of confirmation, including paper-based and electronic communications. The older interim standard is one of the many inherited by the PCAOB in 2003 from the American Institute of CPAs after the Sarbanes-Oxley Act of 2002 created the government-backed audit regulator (see story).
Pugliese objected to the proposal soon after it was issued in December, contending it would unfairly put internal auditors at the center of an effort to regulate issues within CPA firms (see story). However, the comment letter takes aim at the implications of the standard as far as the role of internal auditors, arguing that the proposed change in the standard was presented without any apparent explanation or evidence for the need for such a change.
The PCAOB did not immediately respond to a request for comment.
Previously, the PCAOB's standard for evaluating internal auditors has been the Accounting Standard 2605 (AS 2605), "Consideration of the Internal Audit Function," in which the PCAOB specifically acknowledges that "internal auditors maintain objectivity with respect to the activity being audited."
Pugliese contended the "incongruity between the PCAOB's positions in AS 2605 and the present proposal creates regulatory mixed messages" and "jeopardizes longstanding collaborations between external audit firms and internal auditors."
To address these issues, the letter calls upon the PCAOB to maintain AS 2605 as the standard for evaluating internal auditors' involvement in the confirmation process and to make modifications in the proposed language for the new standard.
"While the scope of responsibilities for each profession is different, internal and external auditors must work in harmony to ensure that the governance, risk and control processes are in place and adequately working," Pugliese wrote. "Disparagement of either audit function — particularly from a government regulatory agency — undermines this partnership and risks engendering public mistrust in the auditing profession."
He called for an open dialogue with PCAOB chair Erica Williams and other PCAOB members to discuss the internal audit profession's concerns about the proposal and to work together to address them.
A Japanese radar satellite took flight on Wednesday evening (Jan. 25), adding to the nation's reconnaissance capabilities.
An H-IIA rocket topped with the IGS (Intelligence Gathering Satellite) Radar 7 spacecraft lifted off from Japan's Tanegashima Space Center Wednesday at 8:50 p.m. EST (0150 GMT and 10:50 a.m. local Japan time on Jan. 26).
"The rocket flew as planned, and it was confirmed that the Information Gathering Satellite Radar 7 was successfully separated," Mitsubishi Heavy Industries, which operates the H-IIA, said via Twitter (opens in new tab) on Wednesday night (in Japanese; translation by Google.)
Related: The history of rockets
According to EverydayAstronaut.com (opens in new tab), IGS Radar 7 is headed toward sun-synchronous orbit, a polar path in which satellites zoom over patches of Earth at the same local solar time each day. A sun-synchronous orbit (opens in new tab) provides consistent lighting conditions over time and is therefore particularly favored by spy and weather satellites.
IGS Radar 7 will be operated by the Cabinet Satellite Information Center (CSICE), which is part of Japan's Cabinet Intelligence and Research Office, as EverydayAstronaut.com noted.
"Not much is known about this specific satellite; however, CSICE has stated that the IGS series of satellites is used for gathering information necessary to national security, as well as crisis management," the outlet wrote in a mission description.
Wednesday's launch was the first of the year for Japan. The nation conducted only one orbital launch in 2022, and that flight, in October, was a failure.
The October 2022 mission involved Epsilon, a 78-foot-tall (24 meters) rocket that had flown just five times previously. (Each of those prior missions was successful.) The H-IIA is much bigger and has far more spaceflight experience.
The 174-foot-tall (53 m) H-IIA has now flown 45 times to date and has failed just once, in November 2003. The powerful rocket has lofted some high-profile payloads since coming online in 2001, including Japan's asteroid-sampling Hayabusa2 spacecraft and the Hope Mars orbiter, the United Arab Emirates' first-ever interplanetary mission.
Editor's note: This story was updated at 12:15 p.m. EST on Jan. 26 to include a tweet by Mitsubishi Heavy Industries, which indicated that the satellite deployed successfully.
Mike Wall is the author of "Out There (opens in new tab)" (Grand Central Publishing, 2018; illustrated by Karl Tate), a book about the search for alien life. Follow him on Twitter @michaeldwall (opens in new tab). Follow us on Twitter @Spacedotcom (opens in new tab) or Facebook (opens in new tab).
The burgeoning psychedelic therapeutics market experienced a boost Jan. 25 as Small Pharma Inc. announced its synthetic, intravenous formulation of N,N-dimethyltryptamine (DMT), SPL-026, led to a statistically significantly, rapid reduction in depression symptoms in patients with major depressive disorder in a phase IIa trial, thus meeting its primary endpoint. DMT is a powerful hallucinogenic tryptamine substance which works as a 5-HT receptor agonist. It is found naturally in various plants, and is a schedule I controlled substance in the U.S. Although lesser known than other psychedelics such as magic mushrooms and LSD, it produces short-lived but intense auditory and visual hallucinogenic effects.
BioWorld Clinical Neurology/PsychiatricRedx Pharma PLC (AIM:REDX) has said it expects to have top-line clinical data from a phase IIa study of its fibrosis candidate in the first quarter of next year as it said patient recruitment was underway in five countries across Europe,
RXC007 is an oral selective Rho Associated Coiled-Coil Containing Protein Kinase 2 (ROCK2) inhibitor and is being evaluated in people with idiopathic pulmonary fibrosis (IPF) – scarring of the lungs that makes breathing difficult.
Redx is carrying out a multi-cohort, randomised, double-blind, placebo-controlled dose-ranging trial that will assess safety, tolerability, and assess for early efficacy signals over a 12-week period.
The trial also includes a 28-day dosing period sub-study to evaluate target engagement and fibrosis modification.
Regulatory and ethics approvals for both the 28-day and 12-week groups have been received in five European countries, and patient recruitment is underway at multiple study sites.
Meanwhile, US enrolment into the 28-day translational science sub-study has begun, but the 12-week cohorts are under a partial clinical hold by the US Food & Drug Administration (FDA) pending additional non-clinical data later this year.
“We anticipate topline data from both the 12-week and 28-day cohorts to be available in the first quarter of 2024,” confirmed Redx chief executive Lisa Anson in a statement.
“Our ongoing non-clinical programme will provide the data needed to support longer-term dosing in the US later this year.
“We're excited about the potential of our next-generation ROCK2 inhibitor, RXC007, to treat fibrotic conditions and address a significant unmet medical need," she added.
BENGALURU: In a major boost to India’s first mission to the Sun, the Indian Institute of Astrophysics (IIA) on Thursday handed over the Visible Line Emission Coronagraph (VELC) payload to the Indian Space Research Organisation for India’s first space mission, Aditya L1, to observe the Sun and the solar corona to be launched in June-July 2023.
The VELC is the primary payload on board Aditya-L1, designed as an internally occulted reflective coronagraph and has been assembled, tested, and calibrated at the Centre for Research and Education in Science and Technology (CREST) Campus of the IIA. One of the main puzzles in solar astrophysics is that the atmosphere of the Sun (called the Corona) is at a temperature of about a million degrees Celsius, whereas the surface of the Sun is only a little below 6,000 degrees Celsius.
Answering this puzzle needs continuous observations of the Corona, right from its lowermost boundary upwards. However, it is very difficult to discard the extremely bright light from the surface of the Sun (the Sun’s disk) and observe the lower Corona. The VELC has an ‘internal occulter’ which separates out the light from the disk and discards it.
The remaining light which is from the Corona, from 1.05 Ro to 3 Ro (where Ro is the radius of the Sun) is sent for further processing. VELC weighs 90kg and is 0.7m X 1.1m X 700mm in dimension. VELC is the largest and one of the most technically challenging of the seven payloads/telescopes that will fly on Aditya-L1. ISRO will now conduct further testing of VELC and its eventual integration with the Aditya-L1 spacecraft.
The IIA successfully finished assembling, testing and calibrating the VELC at its CREST campus in Hoskote, Bengaluru. Accepting a 3D-printed model of the VELC payload from IIA, ISRO Chairman, S Somanath, said, “ISRO aims to pay an important role in future science experiments in space and an ecosystem needs to be created for this, including a roadmap for the next few decades.” M Sankaran, Director of UR Rao Space Centre, ISRO, said an Aditya-L1 helpdesk is being planned which will help scientists and students understand and use Aditya-L1 data.
--Respiratory syncytial virus (RSV) infection treatment remains huge unmet medical needs and there is no effective drug for treatment globally so far
--Dosage of 800 mg ASC10, twice daily was selected to conduct a Phase IIa study in patients with RSV infection
--Preclinical research showed that ASC10-A is a potent inhibitor against RSV both in vitro and in vivo
HANGZHOU and SHAOXING, China, Jan. 31, 2023 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the U.S. Food and Drug Administration ("FDA") has approved to conduct a Phase IIa clinical trial for ASC10 to treat respiratory syncytial virus (RSV) infection. Based on available data, dosage of 800 mg ASC10, twice daily was selected to conduct a randomized, double-blind, placebo-controlled Phase IIa study to evaluate the antiviral activity, safety, tolerability and pharmacokinetics of ASC10 tablets in patients with mild or moderate RSV infection.
ASC10 is an oral double prodrug. After oral administration, ASC10 is rapidly and completely converted in vivo into the active metabolite ASC10-A, also known as β -D-N4-hydroxycytidine (NHC) or EIDD-1931. Preclinical research[1] showed that ASC10-A (NHC) is a potent inhibitor with EC50 of 0.51 to 0.6 uM against two RSV clinical isolates using in vitro infection assay in HEp-2 cells. Furthermore, preclinical research[1] also demonstrated that ASC10-A (NHC) is efficacious in a mouse RSV infection model.
Ascletis has been granted a patent of ASC10 and its derivatives, and their uses to treat multiple virus infections by the United States Patent and Trademark Office (USPTO), including SARS-CoV-2, monkeypox virus and RSV.
RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia (infection of the lungs) in children younger than 1 year of age in the United States[2] and causes approximately 58,000 hospitalizations among children under five annually[3]. RSV infection is estimated to cause about 14,000 annual deaths in U.S. adults over age 65. Globally, RSV affects an estimated 64 million people and causes 160,000 deaths each year [3].
RSV infection treatment remains huge unmet medical needs and there is no effective drug for treatment so far. According to the report from Astute Analytica, the global market of RSV therapies is expected to grow at CAGR of 14.9% from 2022-2027 and reach revenue of US$4.2 billion by 2027[4].
"RSV poses a persistent threat to infants and the elderly population, and so far there is no effective drug available worldwide. We are glad that ASC10 has obtained the U.S. FDA approval to conduct a Phase IIa study to treat RSV infection in patients, which is a new milestone of Ascletis' R&D in treatment for viral diseases. Preclinical research showed that ASC10-A is a potent inhibitor against RSV both in vitro and in vivo, and we will accelerate the Phase IIa clinical study to benefit patients worldwide." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.
About Ascletis
Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has three marketed products, i.e. ritonavir tablets, GANOVO® and ASCLEVIR®, and 23 drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (HBV functional cure), ASC10 and ASC11(oral small molecules for COVID-19 treatment), ASC40 (recurrent glioblastoma), ASC42 (PBC, primary biliary cholangitis), and ASC40 (acne).
For more information, please visit www.ascletis.com.
SOURCE Ascletis Pharma Inc.
FREMONT, CA, Jan. 19, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that Dr. Keith McBurnett, Professor of Psychiatry at the University of California San Francisco, presented the results of the Phase IIa study of its medical treatment, ABV-1505 ADHD, on January 14, 2023 at the 2023 Conference of The American Professional Society of ADHD and Related Disorders (APSARD) Poster Session. APSARD is a world-renowned organization consisting of a broad spectrum of allied mental health experts working to Strengthen the quality of care for patients with ADHD through the advancement and dissemination of research, and evidence-based practices.
The active pharmaceutical ingredient of ABV-1505, PDC-1421, was used in the Phase IIa study which involved six adult subjects with confirmed ADHD. Each patient was administered two doses of PDC-1421 (low, 380mg; and high, 760mg) three times a day for four weeks and a one-week post-treatment follow-up. The study found that both low and high doses of PDC-1421 were safe, well-tolerated and efficacious during the treatment and the follow-up period. Dr.
McBurnett’s presentation is available on the APSARD website at https://apsard.org/2023-conference/ with a Submission ID number 3001531.
As a result of the Phase IIa study results, ABVC is currently conducting a Phase IIb randomized, double-blind, placebo-controlled study entitled “A Phase II Tolerability and Efficacy Study of PDC-1421 Treatment in Adult Patients with Attention-Deficit Hyperactivity Disorder (ADHD), Part II” that will eventually involve a total of approximately 100 patients at the University of California, San Francisco and five research hospitals in Taiwan.
“We were pleased to have the impressive ABV-1505 ADHD Phase IIa study results presented by Dr. McBurnett at the 2023 APSARD Conference,” said Dr. Howard Doong, Chief Executive Officer of the Company. Dr. Doong further noted that “The ABV-1505 Phase IIb study is moving along well with enrollments now exceeding more than 40 subjects.”
According to Grand View Research’s market research report, the ADHD drug market is valued at USD 16.4 Billion in 2018 and expected to reach USD 24.9 Billion by 2025 with the CAGR of 6.4% over the forecast period.
About ABVC BioPharma
ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus) under development. For its drug products, it is focused on utilizing its licensed technology to conduct proof-of-concept trials through Phase II of the clinical development process at world-famous research institutions (such as Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center). For Vitargus, the company intends to conduct the clinical trials through Phase III at various locations throughout the globe.
Forward-Looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified, and, consequently, real results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Contact:
Leeds Chow, CFO
Email: leedschow@ambrivis.com