Replies to post #23411 on Cytodyn Inc (CYDY)

[Emergcy]

These is a mind blowing work. Incredible! The question for me is again why can management not hire you for 4 weeks to go on a roadshow. With such info people would run for shares. Too sad that these guys see no value in marketing.

[Saltz]

Sandra, impressive work. Can’t say enough about your contribution here. I’d like to send you an email. What is your best address.

[finesand]

Compilation Update + Catalyst Calendar


2018-06-23 - Update Log,

2018-06-23 - Evaluation Update,

2018-06-22 - PRO 140 SC Combo about to arrive,

2018-06-14 - Comparison HIV-1 Anti-infective antibodies,

2018-06-14 - Pro 140 Related Publications,

2018-06-14 - Pro 140 Covering Scientists,

2018-06-23 - Insider Ownership,

2018-02-20 - Pro 140 Phase 2b/3 Pivotal PE Achieved,

2018-04-10 - CEO Letter to Investor

Calendar from March 2018 Presentation, PRs & Notes

- DONE: 6/9/18 CD02 Pivotal Phase 3 Endpoint Achieved (ASM Microbe late breaker) (Source: CYDY)
- DONE: FDA meeting until end of June '18 to discus BLA/NDA presenting trial data, determining submission plan (Source: CYDY)
- 2Q18: Publication Studies – CD02 Combo Primary Endpoint Study (Source: CYDY)
- 6/30: CD03 Enrollment Completed by now (239 pts done?!), 24 weeks until end of 2018, 48 weeks until end of June 2019? (Conclusion on 6/22 PR)
- 7/30: Full CD02 Trial Data Disclosure. (Assumption due ASM'18 poster + PR: 17 pts to go since 3/20)
- 7/30: GvHD 30 day data review by iDMC around end of July (CYDY 6/20 PR)
- 3Q18: FDA decision on BTD application using CD02 data (FDA wanted to have efficacy + safety data – CC April 2017)
- 3Q18: Investor Conference Call (IR) (Source: CYDY IR)
- 4Q18: BLA Submission for CD02 Combo end of 2018 (Source: CYDY 6/22 PR)
- 4Q18: CD03 Phase 2b/3 Mono Investigative Trial Readout (probably later, CD03 completion around now + 48 weeks) (Source: CYDY)
- 2019: CD02 HIV Combination Therapy Approval w/ BTD within [2Q19 - 3Q19] (Source: CYDY 6/22 PR)