InMode (INMD+11.7%) expects Q2 revenues in the range of $30.2M – $30.6M vs. consensus of $16.9M and non-GAAP diluted EPS in the range of $0.20 – $0.22 vs. consensus of -$0.09.
The company expects FY2020 revenue outlook will not be lower FY2019 and expects to maintain a gross margin of ~85%.
Q2 financial results will be out on August 5, before market opens.
Celsion (NASDAQ:CLSN) plummets 65% premarket on robust volume in reaction to its announcement that the independent Data Monitoring Committee (DMC) has recommended the termination of the Phase 3 OPTIMA study evaluating ThermoDox, combined with radiofrequency ablation (RFA), in patients with hepatocellular carcinoma or primary liver cancer.
The DMC made its recommendation based on a pre-planned interim safety and efficacy analysis that showed the study was unlikely to achieve the primary endpoint after exceeding a futility threshold value.
The FDA has issued a Refusal to File letter to CytoDyn (OTCQB:CYDY) related to its marketing application seeking approval of the combination of leronlimab and HAART (highly active antiretroviral therapy) for highly treatment-experienced HIV patients.
A Refusal to File letter means that the application was not complete enough to allow for a substantive review.
The company plans to request a meeting with the agency to discuss the issue, adding that its request does not specify the need for additional clinical trials, rather additional analyses of completed studies, a requirement it says it can provide “as soon as possible.”
On another note, it plans to lock and unblind the data this week from its Phase 2 clinical trial evaluating leronlimab in COVID-19.
A periodic safety review of data from the Phase 3 trial assessing leronlimab in severely/critically ill COVID-19 patients by the independent Data Safety Monitoring Committee is planned for next week. Results from both studies will be announced this month.
Management will host a conference call today at 4:00 pm ET to discuss the above.
People who have recovered from Covid-19 may lose their immunity to the disease within months, according to research suggesting the virus could reinfect people year after year, like common colds.
In the first longitudinal study of its kind, scientists analysed the immune response of more than 90 patients and healthcare workers at Guy’s and St Thomas’ NHS foundation trust and found levels of antibodies that can destroy the virus peaked about three weeks after the onset of symptoms then swiftly declined.
Blood tests revealed that while 60% of people marshalled a “potent” antibody response at the height of their battle with the virus, only 17% retained the same potency three months later. Antibody levels fell as much as 23-fold over the period. In some cases, they became undetectable.
“People are producing a reasonable antibody response to the virus, but it’s waning over a short period of time and depending on how high your peak is, that determines how long the antibodies are staying around,” said Dr Katie Doores, lead author on the study at King’s College London.
The study has implications for the development of a vaccine, and for the pursuit of “herd immunity” in the community over time.
The immune system has multiple ways to fight the coronavirus but if antibodies are the main line of defence, the findings suggested people could become reinfected in seasonal waves and that vaccines may not protect them for long.
“Infection tends to give you the best-case scenario for an antibody response, so if your infection is giving you antibody levels that wane in two to three months, the vaccine will potentially do the same thing,” said Doores. “People may need boosting and one shot might not be sufficient.”
Early results from the University of Oxford have shown that the coronavirus vaccine it is developing produces lower levels of antibodies in macaques than are seen in humans infected with the virus. While the vaccine appeared to protect the animals from serious infection, they still became infected and may have been able to pass on the virus.
Speaking on Sky News, Prof Robin Shattock of Imperial College London said a competing vaccine developed by his group could be available in the first half of next year if clinical trials go well. But he cautioned there was “no certainty” any of the vaccines in development would work, and said it is still unclear what kind of immune response is needed to prevent infection.
The King’s College study is the first to have monitored antibody levels in patients and hospital workers for three months after symptoms emerged. The scientists drew on test results from 65 patients and six healthcare workers who tested positive for the virus, and a further 31 staff who volunteered to have regular antibody tests between March and June.
The study, which has been submitted to a journal but has yet to be peer-reviewed, found that antibody levels rose higher and lasted longer in patients who were severe cases. This may be because the patients have more virus and churn out more antibodies to fight the infection.
There are four other types of coronavirus in widespread circulation, which cause the common cold. “One thing we know about these coronaviruses is that people can get reinfected fairly often,” said Prof Stuart Neil, a co-author on the study. “What that must mean is that the protective immunity people generate doesn’t last very long. It looks like Sars-Cov-2, the virus that causes Covid-19, might be falling into that pattern as well.”
Prof Jonathan Heeney, a virologist at the University of Cambridge, said the study confirmed a growing body of evidence that immunity to Covid-19 is short-lived. “Most importantly, it puts another nail in the coffin of the dangerous concept of herd immunity,” he said.
“I cannot underscore how important it is that the public understands that getting infected by this virus is not a good thing. Some of the public, especially the youth, have become somewhat cavalier about getting infected, thinking that they would contribute to herd immunity. Not only will they place themselves at risk, and others, by getting infected, and losing immunity, they may even put themselves at greater risk of more severe lung disease if they get infected again in the years to come.”
But Prof Arne Akbar, an immunologist at UCL, said antibodies are only part of the story. There is growing evidence, he said, that T cells produced to fight common colds can protect people as well. Those patients who fight the virus with T cells may not need to churn out high levels of antibodies, he added.
Shattock said the study was important and indicated that neutralising antibodies rapidly wane. “This certainly suggests that we cannot be confident natural infection will be protective for a significant proportion of individuals, nor certain of the duration of any protection.”
He added: “We would however expect that re-infection would be less severe for any individual as they will still retain immune memory allowing them to more rapidly respond. Nevertheless they could still be a source of onward transmission.
“It does indicate that vaccines need to do better than natural infection, providing consistent responses in the majority of individuals and sustained levels of protective antibodies. Ultimately this may require the use of annual boosting immunisations, particularly for the most vulnerable. This could be delivered alongside annual influenza immunisations.”
The clinical trials of the world’s first coronavirus vaccine on volunteers at Sechenov First Moscow State Medical University has been successfully completed, Vadim Tarasov, the director of the Institute for Translational Medicine and Biotechnology, told Sputnik, adding that the first group of volunteers would be discharged on Wednesday and the second on July 20. The university began clinical trials of the vaccine produced by Russia’s Gamalei Institute of Epidemiology and Microbiology on June 18.
“Sechenov University has successfully completed tests on volunteers of the world’s first vaccine against coronavirus,” Tarasov said. According to Alexander Lukashev, the director of the Institute of Medical Parasitology, Tropical and Vector-Borne Diseases at Sechenov University, the objective of this stage of the study was to show the vaccine’s safety for human health, which was successfully done.
“The safety of the vaccine is confirmed. It corresponds to the safety of those vaccines that are currently on the market,” Lukashev told Sputnik. The further vaccine development plan is already being determined by the developer’s strategy, including the complexity of the epidemiological situation with the virus and the possibility of scaling up production, Lukashev added.
“Sechenov University in a pandemic situation acted not only as an educational institution but also as a scientific and technological research center that is able to participate in the creation of such important and complex products as drugs … We worked with this vaccine, starting with preclinical studies and protocol development, and clinical trials are currently underway.
Mayor Sylvester Turner is proposing a two-week shutdown to ‘re-calibrate’ as COVID-19 cases continue to increase.
Turner said Saturday he believes there’s nothing wrong with taking a few steps back and he acknowledged the city reopened too quickly.
Two weekends ago ABC13 spoke with Turner and asked if he would support another shut down. Then, he did not say yes or no, but he said he felt like the city had its chance to get people to stay home in March and it would be very challenging to get them to do it a second time.
“We have to acknowledge the fact that the numbers are continuing to rise,” said Turner. “Not everybody is going to wear a mask. Let’s be real. Even with the requirement.”
Turner said the number of people needing to go to the hospital needs to be slowed down.
National School of Tropical Medicine Dean Dr. Peter Hotez agreed with the shut down proposal. Hotez said other states need to do the same
He said hard choices need to be made now so schools and colleges can reopen safely in the coming months.
“I’m very frustrated by the fact that everything’s being sort of left up to the governors and the governors and the states just don’t have the epidemiological models and the horsepower to make those kinds of evidence-based decisions,” said Hotez.
Harris County Judge Lina Hidalgo voiced her support for another shut down for several weeks.
Gov. Greg Abbott, however said it is the last thing he wants to do, but it could happen if the virus doesn’t slow down.
Canada’s effort to fast-track careers of foreign-trained doctors to meet growing patient numbers during the COVID-19 pandemic has resulted in only about two dozen licenses approved in Ontario and none in British Columbia, according to medical colleges in both provinces.
As Canada faced the prospect of the pandemic swamping the country’s healthcare system, British Columbia created a new class of license that would allow overseas-trained doctors to practice under the supervision of a fully licensed doctor, similar to licenses that exist in other provinces, such as Alberta.
In Ontario, the medical college activated a short-term license program that would allow hospitals to hire internationally trained doctors on short notice.
But the programs have had very little uptake since being launched in May in British Columbia and February in Ontario.
Immigrant doctors and their advocates say this is because requirements for the new license categories did almost nothing to allow more physicians to apply, and the licenses were poorly communicated to both applicants and hospitals.
The overburdened healthcare system is frequently an election issue in many Canadian provinces. A 2019 report from the Canadian Institute of Health Information found that Canada had 241 physicians per 100,000 people. Ontario had 234 physicians per 100,000, and British Columbia had 250. The OECD average is roughly 350 physicians per 100,000 people, according to a 2020 report by the Commonwealth Fund, a New York-based health foundation.
Amir Bajehkian, a co-founder of Trained to Save Lives, a Vancouver-based advocacy group for international medical graduates, said he was optimistic when British Columbia initially announced the new class of license.
He hoped it would fulfill requests foreign-trained doctors had been making for years.
But the requirements – at least two years’ postgraduate training, strict English fluency and a specialty in acute care – barely moved the needle on who was able to apply, Bajehkian said.
“A lot of physicians are like, what’s the point? Why are you doing this?” he said.
Ontario doctors face a similar situation, said Ahmad Al-Khatib, 33, an Iraqi who practiced in the United Arab Emirates before coming to Canada four years ago.
“When the pandemic started I felt so helpless, even useless,” Al-Khatib said. “I have all this experience and I’m seeing people dying around me and this is where I used to work – I used to work in the emergency.”
The College of Physicians and Surgeons of Ontario said that if applicants met all the requirements, including confirming employment with the hospital, they would be granted a license. The College of Physicians and Surgeons of British Columbia declined to comment.
Even in Alberta, which has had a pathway similar to that in British Columbia for over 10 years, the challenges are steep.
Claudia Avila, 39, an obstetrician and gynecologist with 11 years of experience in her home of Venezuela, emigrated to Canada with her husband and daughter four years ago.
For Edmonton area-based Avila, it took years of saving to pay for the costly exams and its preparations. Then the regulations changed and she had to start over.
Avila came to Canada on a skilled worker visa, she said. “Then we come here and we see that they don’t even care… It is very sad. I would say I wouldn’t be here if I knew it was going to be that hard.”
