Ryan Mee, CEO of Fulcrum Metals, reviews FY23 and progress on the Gold Tailings Hub in Canada. Watch the video here.
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Imagine knowing about a fast track of FDA investment before an official RNS...
Nice heads up pre RNS
BOOOOOM!
Fast track (FDA) Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need.
WESTPORT, Conn., April 17, 2019 (GLOBE NEWSWIRE) -- Intensity Therapeutics, Inc., a clinical-stage biotechnology company pioneering a novel, immune-based approach to treat solid tumor cancers through direct injection of its proprietary therapeutic agents, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s development program evaluating INT230-6 for the treatment of patients with relapsed or metastatic triple negative breast cancer (TNBC) who have failed at least two prior lines of therapy.
“We are extremely pleased to receive this Fast Track designation, which validates the potential of INT230-6 to treat patients with relapsed or metastatic triple negative breast cancer as a single agent,” said Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. “Finding improved therapies for this disease is a critical unmet medical need, and we look forward to working closely with the FDA this year to initiate a Phase 2 clinical study for this indication.”
Approximately 15-20% of breast cancers test negative for estrogen receptors, progesterone receptors, and excess HER2 protein, qualifying them as triple negative. TNBC is considered to be more aggressive and have a poorer prognosis than other types of breast cancer, mainly because there are fewer targeted medicines. According to a study published in the Journal of Clinical Oncology, patients who fail two lines of therapy for TNBC typically progress within nine weeks. Those who have failed three lines progress within four weeks.
“This important regulatory designation is based on the promising data observed to date from use of INT230-6 in our breast cancer research,” said Ian B. Walters, M.D., Chief Medical Officer of Intensity Therapeutics. “The Fast Track designation will allow us to engage robustly with the Agency to most effectively and efficiently develop our new cancer treatment approach, as well as help us determine other potential indications to pursue for INT230-6. To date, our ongoing Phase 1/2 trial has treated patients with more than 14 different types of advanced solid tumors including TNBC, and we look forward to evaluating use of INT230-6 in other areas for potential registration-enabling studies.”
The FDA’s Fast Track program facilitates development and expedites the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. A fast track drug must show some advantage over available therapy. Fast Track designation allows early and frequent communication between the FDA and a drug company, often leading to earlier drug approval and access by patients. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.