Replies to post #1696 on Cytodyn Inc (CYDY)

[XBRIANX]

No, the application is filed well before the end of the patients trial so that this lapse will not occur. If approved it hints at the efficacy of PRO 140 as well as its likelihood to be approved in the future imo

CytoDyn Files a Compassionate Use Protocol
SPECIAL NEED FOR PRO 140 FOR A PATIENT WHO IS REACHING THE END OF OUR PHASE 3 STUDY

VANCOUVER, Wash., April 14, 2016 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announced today that it filed with the FDA a protocol for a compassionate use of PRO 140 to allow a patient who is reaching the end of the Phase 3 combination study to continue treatment with PRO 140 for an extended period of time. This compassionate use protocol will enable the patient to remain on PRO 140 upon successful conclusion of their 25-week participation in the trial.

We believe this protocol is important for patients who were unable to achieve a completely suppressed viral load (<50 HIV RNA copies/mL) under a Highly Active Anti-Retroviral Therapy (HAART) regimen prior to enrolling in our Phase 3 combination study. Now that the patient is concluding 25 weeks in the trial, the patient and the treating physician requested continued access to PRO 140 beyond the completion of the patient's participation in the PR0140_CD02 study in order to maintain the suppressed viral load. Under the protocol, patients in this study would be taken off of PRO 140 after 25 weeks and would remain on their optimized HAART regimen, as prescribed by their treating physician.

Nader Pourhassan, Ph.D., CytoDyn President and CEO, commented: “CytoDyn’s first patient to complete the Phase 3 combination trial has demonstrated the medical need to remain on PRO 140 to maintain a suppressed viral load, which was not previously attainable by this patient under several years of a HAART regimen.” Dr. Pourhassan added: “It is important to note that only about 30% of all HIV patients in the U.S. have attained a complete suppressed viral load, which is the level at which HIV transmission is negligible. We believe that a compassionate use designation will allow patients who benefit from adding PRO 140 to their OBT regimen to maintain transmission-free maintenance after completing our Phase 3 trial.”

[Inoviorulez]

Wasn't the patient nearing the end of the trial? They requested this before the patient reaches the end. Which means the decision should come before the patient is concluded with the trial.

"- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announced today that it filed with the FDA a protocol for a compassionate use of PRO 140 to allow a patient who is reaching the end of the Phase 3 combination study to continue treatment with PRO 140 for an extended period of time. "

right in the press release they requested this before the patient reaches the end of the trial. If the FDA agrees to it, the patient will be able to remain on PRO 140 therapy adjunct therapy.