Cytodyn Inc (CYDY)

[finesand]

yup, my updated CD02 section now looks like the following.

- CD02 Pivotal Combo Phase 3, 52 patients for 25 weeks, up until September 2018
-- Part-1 PE Efficacy reached R > 0.5log10 1 week after 1 350mg injection
-- Part-2 OBT phase for 24 weeks,
-- Weekly 350mg subcutaneous injection of PRO 140
-- Result
--- PE Efficacy part-1 is p ~ 0.0032
--- 3 early exits, 49 pts completed part-1, 32 pts completed part-2
--- 17 pts ongoing in part-2: 7/10 - 8/6 to complete?
--- 27/35 pts moving into rollover study after completing 25 weeks: 77.14%
-- Safety data of CD03 Mono to support rolling BLA submission, orig from 100pt.
-- 6/9/18 CD02 Pivotal Phase 3 Endpoint Achieved (ASM Microbe late breaker)
-- Has Fast Track Designation, eligible for Priority Review and Rolling BLA/NDA
-- 3Q18: BLA Submission for CD02 Combo (rolling BLA)
-- 2019: CD02 HIV Combination Therapy Approval w/ BTD
-- ClinicalTrials.gov Identifier: NCT02483078