Todos Medical Receives FDA Certificate of Free Sale for New 5-Day Tollovid Dosing Regimen
Download as PDFMAY 04, 2021 8:30AM EDT
Company sees this new dosing regimen of 60 pills over 5 days as optimal for Tollovid, the Company’s 3CL protease inhibitor botanical dietary supplement that helps to support and maintain healthy immune function
NEW YORK, NY, and REHOVAT, ISRAEL, May 04, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that the US Food & Drug Administration granted the Company a new Certificate of Free Sale for a second dosing regimen for Tollovid™ as a dietary supplement. Under the new Certificate of Free Sale, the Company is authorized to market Tollovid with a dosing regimen of 60 pills over a five-day period, equivalent to 12 pills per day. Tollovid, a potent 3CL protease inhibitor botanical product, is a dietary supplement that helps to support and maintain healthy immune function. The 3CL protease is an important part of certain coronavirus’ reproductive mechanism, and inhibiting this protease may help to support and maintain healthy immune function in the face of circulating coronaviruses. The Company sees this dosing regimen for Tollovid as optimal for supporting healthy immune function.
“We were very pleased with the speed with which this dosing regimen for Tollovid was granted a new Certificate of Free by the US FDA,” said Gerald E. Commissiong, President & CEO of Todos Medical. “After a successful initial launch at The Alchemist’s Kitchen in New York City, where we gained significant feedback from customers on what worked best for them with Tollovid, we developed an upgraded dosing regimen based on the first-hand experience of customers that had a successful experience with the product. With that critical information and this new Certificate of Free Sale in hand, we are now preparing to launch Todos Medical’s branded Tollovid product into the US market via a soon to be launched website www.MyTollovid.com in a direct-to-consumer model with overnight shipping. We also intend to explore opportunities to distribute Tollovid in other areas of the world that are eagerly seeking new products that can potentially inhibit 3CL protease, and are in active discussions with distributors to bring this product forward in those markets.”
The Company intends to utilize a portion of the proceeds from a recently completed $3.3 million fixed price crossover investment with Yozma Group, a venture capital firm from South Korea, to help with the Tollovid launch. With Yozma’s recent investment, Todos has raised $9.7 million in this crossover round since January 2021. In addition to the Tollovid launch, the Company is utilizing the proceeds from these investments to retire certain outstanding debts, further advance the ongoing Phase 2 clinical trial of the Company’s oral 3CL protease targeting drug candidate Tollovir™ for hospitalized COVID-19 patients, the completion of initial clinical studies for the Company’s 3CL protease targeting COVID-19 diagnostic assay Tollotest™ and general corporate purposes.