Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
From December 18, 2019 rns
About Michael Schmainda
Michael has a 20-year history of successfully building global medical imaging businesses including Prism Clinical Imaging and Imaging Biometrics. As co-founder of IB, and has overseen all aspects of the companyâs development, operation, and growth since its inception
Confirmation I have received today.
The Orphan Drug Designation application was submitted Dec 12. The FDA states a 90 day (calendar days) review period. Like the 510(k) process, this means that we will hear back from the FDA in 90 days â it does not imply âapprovalâ.
Hope this helps. Good luck all!
From the latest newsletter January 23
Clinical Trial Update
Our sponsorship of the Phase I clinical trial of gallium maltolate (GaM) in the treatment of brain cancer remains a top priority. The screening and enrollment of subjects continue at an outstanding pace, and follow-up visits are increasing as more subjects remain on the study. In late 2022, an Orphan Drug Designation application for GaM was submitted to the US Food and Drug Administration (FDA). The FDA has 90 days to review the application. If granted, Orphan Drug Designation provides exclusive marketing and development rights, tax credits for clinical trial expenditures, and potential decreased wait-time for drug approval.
Interesting read regarding Gallium maltolate (GaM). Also in the Selected Review Articles on the Therapeutic Applications of Gallium at the bottom includes many papers with Kathleen M. Schmainda and Christopher R. Chitambars name.
https://www.gallixa.com/LRB/GaMForCancer.html
https://www.gallixa.com/GAMReferences/AlhajalaEtAl2020.pdf
https://www.gallixa.com/GAMReferences/AlhajalaEtAl2020.pdf
Hereâs a snippet from the article
Gallium maltolate has been administered to healthy volunteers and to some late-stage cancer patients in Phase I clinical trials. It has been given at doses as high as 3,500 mg/day for multiple 28-day cycles, with no dose-limiting toxicity or serious drug-related adverse effects. The compound has shown high oral bioavailability with an elimination half-life of approximately 17 to 21 hours. Anecdotal efficacy has been observed in patients with lymphoma, end-stage liver cancer (hepatocellular carcinoma), metastatic prostate cancer, metastatic colon cancer, metastatic lung cancer, and metastatic breast cancer.
As an example, a patient with inoperable, late-stage liver cancer, who had not responded to chemotherapy with sorafenib (NexavarÂŽ), was administered a daily dose of oral gallium maltolate. Prior to gallium maltolate treatment, the patient had severe right abdominal pain, elevated serum bilirubin, anorexia, and could not perform most routine activities. A gallium-67 scan showed avid gallium uptake by the 20 cm tumor. Within two weeks following the start of gallium maltolate treatment, the patient's right abdominal pain had decreased substantially. Two months following the start of treatment, the patient had resumed most normal activities, serum bilirubin was well within the normal range, and a CT scan showed apparent extensive necrosis and shrinkage of the tumor
Aidan the funding rns was the 16th not 18th
Tintra Foundation raises an impressive $450,000 for UNICEF at Winter Gala Ball
The Tintra Foundation has raised an incredible $450,000 for UNICEF after auctioning a once-in-a-lifetime expedition at the UNICEF x LuisaViaRoma Winter Gala Ball in St Barth.
With special performances by Lenny Kravitz and Drake, the LuisaViaRoma Winter Gala Ball for UNICEF welcomed some 700 benefactors, celebrities, and influential guests united in a passion for philanthropy, to raise funds in support of the charity and its commitment to protecting vulnerable children across the globe.
The Tintra Foundation, the charitable arm partner of Tintra plc and the broader Tintra Group, is focused on high impact work in the emerging world where it relates to cultural understanding especially with its work with the worldâs last remaining Hunter-Gatherer Tribes, who remain key to keeping natural evolution alive.
The Foundation is representative of Tintraâs commitment to the emerging world and in driving inclusion of all kinds across developing regions by building technology that is free of social, cultural, and geographic bias.
Along with Foundation Board Member Johan Ernst Nilson, one of the worldâs best-known explorers, Adventure Activists and Philanthropists â who has successfully completed over 60 expeditions across 179 countries â the Tintra Foundation donated a once-in-a-lifetime trip for auction at the Winter Gala Ball.
The highest bidder along with 4 guests will be joining Johan on a trip to the top of planet Earth in an expedition high up in to the Arctic, where the group will spend six nights close to the North Pole enjoying the Northern Lights.
Auctioned for $450,000, the donated expedition will aid UNICEFâs mission in providing care and protection to vulnerable children across the globe, contributing more 10% to a total amount raised of $4,000,000 via the auction.
Gala Ball attendees included Mike Tyson, Leonardo Di Caprio, and Rita Ora, who all had the opportunity to bid for 17 different luxury auction lots, including Elvis Presleyâs 1971 Harley Davidson Motorcycle and Steve McQueenâs own 1961 Formula Junior race car.
Discussing the success of the evening, Richard Shearer, Board Member of the Tintra Foundation, said: âTintra as a group is focused on bringing people and communities together, sometimes that is through investment, sometimes through banking and at other times through the work of the foundation. Along with other foundation members, I was lucky enough last year to spend time in Papua New Guinea with some of the last remaining Hunter-Gatherer tribes, and it is this connection with people such as these that drives my passion for inclusion across the world in all of its forms.
All Tintra Foundation resources have been pledged to understanding, supporting, and increasing awareness around the world and to understanding peoples and cultures better. Striving to prove my belief that there is much more that connects us than separates us. By doing this the
Lol!!! You can smell the desperation from the shorters lol!! Burn!!
Boom boom boom !!
Muppet!
We are excited to announce the expansion of IB Clinic via TeraReconâs Eureka Clinical AI platform.
Director of AI Partnerships, TR. âWith the launch of IB software on the Eureka Clinical platform, customers can immediately benefit from IBâs leading neuro oncology algorithms.â
We are pleased to announce that we have recently engaged big4 firm Ernst & Young
@eynews
as our professional advisor to assist in the submission to the PRA of our UK Banking Licence application that has been materially processed thru the summer #ai #tnt
TINTRA PLC
("Tintra", the "Group" or the "Company")
Contract with Temenos for Core Banking Software
The board of directors (the "Board") of Tintra, the rapidly innovating Deep Tech & Banking business, is pleased to announce that it has contracted with Temenos AG ("Temenos"), the Swiss-based class-leading provider of core banking software, whose existing customers include a large number of the world's most well-known banks. Temenos will provide its core banking software to Tintra, which will be integrated with Tintra's innovative artificial intelligence-based approach to customer and transaction identification.
Temenos is widely recognised by banking regulators globally for delivering compliant, innovative solutions at scale. The Temenos core banking software therefore will provide going forward a key element of the Tintra proposition as it continues to seek approval for the banking and payments licences that have been previously announced.
The integration of the Temenos core banking software is a fundamental element in enabling the roll out of the Company's strategy, as set out in the recently published annual report. The contract with Temenos involves the delivery of software as a service ("SaaS") over a 5-year period, with variable elements. Year One costs are expected to be in the range of US$250,000 to US$500,000 with subsequent year costs increasing as operations start and as customer and transaction levels scale.
Richard Shearer, the Company's Chief Executive, said "Temenos is the world leader in providing banking core technology. As such Temenos is the perfect partner in many ways. As whilst we are innovating in areas where nobody else is or indeed can, we took the view that we wanted the banking core that was familiar to the regulators we're speaking to across the world and had been tried and trusted across a range of territories.
We want to radically innovate where we can but ensure that we are using best in class tech where we think that others offer benefit, and we strongly feel this transaction achieves that goal."
IB StoneChecker is an innovative software tool to aid clinical decisions by providing information about a patientâs kidney stone. The tool provides a semi-automated assessment with useful clinical metrics using the patientâs non-contrast CT scans. #kidneystones
https://twitter.com/IQAI_IB/status/1567191213522190336
Great news! "I am a participant in this trial. It has been a very positive experience so far."
A facebook comment by a participant in theIB Phase I Trial (Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma). http://clinicaltrials.gov NCT04319276
Try this One
https://fda.report/Company/Imaging-Biometrics-L-L-C