CytoDyn Inc. (CYDY): Leronlimab is their lead candidate and this HIV drug is on the cusp of approval and filing their BLA in the coming week. They are expecting approval by Q2 2020 for combination use of HIV for failed patients. With a 95% responder’s rate in monotherapy this could be a shoe in to file for BTD in HIV monotherapy. They have also said that if their results continue to track in Triple Negative Breast Cancer (TNBC) they will file for BTD by the end of January 2020. The company reported a reduction in Circulating Tumor Cells (CTCs) to zero within 2 injections. They expect to have 4 more patients enrolled in the coming days which would allow them to ask for a BTD assuming the patients continue to track. The significance of the data is that keeping CTC’s below 5 copies / dL dramatically increased the 5 year survival rate. Leronlimab is a platform technology drug and they could see a minimum of 2 to 4 BTD’s in the coming year. They are ready to start dosing in their NASH and Graft Versus Host Disease (GvHD) trials and expect read outs next year that could add to the story. Conservative revenue forecasts call for $2.1 - $4.2 billion in the first year exceeding all measures of blockbuster status. This is clearly one to watch