Cytodyn Inc (CYDY)

[Midasbro]

This is just the beginning...

Can a sponsor submit a request for breakthrough therapy designation for multiple indications of the same drug? A breakthrough therapy designation applies to a combination of a drug (either alone or in combination with other drugs) and the specific use for which it is being studied. A separate breakthrough designation request must be submitted for each proposed development program (i.e., each indication for a drug (or drug combination)).

http://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies

PRESS RELEASE:

“Our collective team of key opinion leaders believes that all patients with similar cancers in regards to CCR5 expression may also benefit from the use of leronlimab, including melanoma, brain, throat, lung, stomach, breast, ovarian, uterine, pancreatic, bladder, and thyroid cancer patients. We also believe the mechanism of action for leronlimab may have potential indications in autoimmune diseases such as multiple sclerosis, polymyolitis, Crohn’s disease, inflammatory bowel syndrome and psoriasis.”