Cytodyn Inc (CYDY)

[finesand]

trding- well said. Little recap..

It crossed my mind as well, company didn't overstate market size, but probably made an understatement. Why? Possibly due to same reasons showing the evaluation makes people laugh compared to current traded value?
The combo filter criteria got indeed lightened up lately and voila, enrollment kicks in.

A little Combo Primary Endpoint Recap, this awesomeness seems to have been all forgotten. Good morning.

2018-02-20 PE Combo Reached p<0.01, HIV-1 RNA Viral Load Reduction > 0.5log (or 68%) within One Week & One Injection
Official PR https://globenewswire.com/news-release/2018/02/20/1361653/0/en/CytoDyn-Reports-Primary-Endpoint-Achieved-in-PRO-140-Pivotal-Combination-Therapy-Trial-in-HIV-Infection.html
-- Enrolled patients all had plasma HIV-1 RNA ≥400 copies/mL and documented detectable viral load within three months prior to the screening visit.
-- In the one-week, randomized, double-blind, placebo-controlled portion of the trial,
all trial patients received their existing ART therapy, with one-half of the enrolled patients administered a 350mg subcutaneous injection of PRO 140
-- The trial’s primary endpoint was the proportion of participants with greater than 0.5log reduction in HIV-1 RNA viral load from baseline at the end of the one-week treatment period
-- At one week, patients in the PRO 140 arm showed a statistically significant reduction in HIV-1 RNA viral load of greater than 0.5log from baseline versus patients in the placebo arm, (p<0.01)
-- Following this one-week period, all patients continue in the trial for an additional 24 weeks with PRO 140 weekly subcutaneous injections and optimized ART.
-- It is truly exciting that PRO 140 surpassed the one-week viral load reduction endpoint in what is certainly our most significant clinical trial result to date for this therapeutic candidate,

POZ https://www.poz.com/article/injectable-pro-140-hiv-treatment-hits-research-milestone
-- a single injection reduced study participants’ viral load by half a power of 10 (68 percent) - Note, that is 0.5log reduction
-- After one week, those who received PRO 140, received a greater than half a power of 10 reduction in their viral load compared with those who received the placebo.

Finalizing Trial:
-- Trial continues for 24 weeks, 6 month
-- 2018-08-20 End
-- Then BLA

2018-06-09 11am - 1pm: ASM Microbe 2018 Poster Session
https://www.cytodyn.com/media/press-releases/detail/274/cytodyn-to-present-primary-efficacy-endpoint-results-from
-- announces that an abstract with primary efficacy results from its PRO 140 pivotal combination therapy trial in treatment-experienced
HIV patients has been accepted for presentation at a late-breaking session at ASM Microbe 2018.
The conference is being held June 7-11, 2018 at the Georgia World Congress Center in Atlanta.
http://www.abstractsonline.com/pp8/#!/4623/presentation/15313
-- AAR LB15 / SATURDAY - AAR LB15 - Primary Efficacy Results of PRO 140 SC in a Pivotal Phase 2b/3 Study in Heavily Treatment-Experienced HIV-1 Patients