Weingart told Prensa Latina in this capital that they have the Food and Drug Administration (FDA) approval to begin phase 3 of these clinical trials.
“We could operate under the protection of an exception to the embargo (blockade) that allows joint medical research projects involving us and Cuban organizations, so we have taken advantage of this provision to move forward with this project,” he said.
The US doctor announced that the trial will involve about “180 patients in some 25 centers” in the country, and “we think it will take about 18 months to complete. We hope to be on the market by mid-2028 with this drug approved by the FDA.
In response to a reporter’s question about the population with this affliction here, Dr. Weingart stated that “38.4 million US citizens have diabetes, 1.6 million of which will develop a diabetic foot ulcer each year.”
Of that figure, “160,000 will result in amputation, and 80,000 of those will die in the next five years, so if you follow the cycle, 80,000 people die every year from the complications of a diabetic foot ulcer, making it the eighth leading cause of death in the United States and more deadly than certain kinds of cancer,” he warned.
On Thursday, Weingart attended an event sponsored by the Cuban Embassy in the United States, where the opportunities for bilateral cooperation in biomedical and biotechnology research were highlighted.
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