Here's from a recent WinSanTor communication indicating compassionate use could commence as early as January, 2025:

Under the Fast Track designation WST-057 has been granted by the FDA, WinSanTor can provide the product to patients within the Expanded Access program, which most people know as compassionate use.

Expanded Access is granted to patients who have no solution for life-threatening conditions, or suffer from seriously debilitating conditions. If all goes well, the process of getting WST-057 into patients’ hands could begin as early as January 2025.

PFS patients in the US who suffer from PN can then discuss compassionate use of WST-057 with a licensed physician. If the physician agrees that the drug might benefit the patient, the physician will file paperwork with the FDA, who in turn will allow WinSanTor to fill the prescription.

WinSanTor CEO Stan Kim notes that his company has limited resources for drug approval, so Expanded Access patients will need to pay the direct costs of the drug, which is estimated at $300 per bottle, and lasts about a month. The initial release will be earmarked for patients who participated in the diabetic peripheral neuropathy study, but WinSanTor will look to expand to other indications shortly thereafter.

“The best thing interested patients can do now is complete our anonymous SSD survey as soon as possible, while encouraging fellow patients to do that same,” says Kim. “The more patients who participate, the more likely it is we can raise additional funding to continue exploring WST-057’s efficacy within the PFS and PSSD patient populations.”

Finally, he adds, patients should subscribe to the WinSanTor newsletter and watch for updates on WST-057’s availability via Expanded Access.