This is a post from Trding on 2/1/19 - sounds to m
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Posted On: 04/17/2019 12:48:25 PM
This is a post from Trding on 2/1/19 - sounds to me like the 100 patients on 700 mg will come current mono trial, not pivotal...
Post # 34702 of 39958
https://www.cytodyn.com/media/press-releases/...l-with-fda
Successful interim results in the 700 mg monotherapy arm prompted the FDA to allow CytoDyn to switch all remaining combination therapy patients from CD02-Extension study from 350 mg to 700 mg dose
CytoDyn is in negotiations for post-approval sales distribution channels with potential upfront payment to CytoDyn
VANCOUVER, Washington, Feb. 01, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company developing new antibody therapies for combating human immunodeficiency virus (HIV) infection and potentially disrupting cancer metastasis, announces that it had a productive conference call meeting with the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) submission. This was the first follow-up meeting since its June 2018 pre-BLA meeting regarding the Company’s planned submission of its BLA and the positive interim data of its 700 mg monotherapy trial. The FDA recognized that the higher dosage of 700 mg in the monotherapy trial had a much higher response rate than the 350 mg dose used in the combination therapy trial. In order to avoid a long delay in the BLA filing, the FDA agreed to accept safety data from 100 patients in the monotherapy trial with the 700 mg dose, which enables the BLA submission for the combination therapy to use 700 mg instead of the original 350 mg dose.
CytoDyn currently has 45 patients enrolled in monotherapy with 700 mg, 29 additional patients who have switched from lower doses to the 700 mg dose and over 40 patients currently in screening to initiate 700 mg dose arm of monotherapy trial. The FDA also gave CytoDyn permission to upgrade all ongoing patients who are currently on 350 mg in the combination therapy to 700 mg dose.
Post # 34702 of 39958
https://www.cytodyn.com/media/press-releases/...l-with-fda
Successful interim results in the 700 mg monotherapy arm prompted the FDA to allow CytoDyn to switch all remaining combination therapy patients from CD02-Extension study from 350 mg to 700 mg dose
CytoDyn is in negotiations for post-approval sales distribution channels with potential upfront payment to CytoDyn
VANCOUVER, Washington, Feb. 01, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company developing new antibody therapies for combating human immunodeficiency virus (HIV) infection and potentially disrupting cancer metastasis, announces that it had a productive conference call meeting with the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) submission. This was the first follow-up meeting since its June 2018 pre-BLA meeting regarding the Company’s planned submission of its BLA and the positive interim data of its 700 mg monotherapy trial. The FDA recognized that the higher dosage of 700 mg in the monotherapy trial had a much higher response rate than the 350 mg dose used in the combination therapy trial. In order to avoid a long delay in the BLA filing, the FDA agreed to accept safety data from 100 patients in the monotherapy trial with the 700 mg dose, which enables the BLA submission for the combination therapy to use 700 mg instead of the original 350 mg dose.
CytoDyn currently has 45 patients enrolled in monotherapy with 700 mg, 29 additional patients who have switched from lower doses to the 700 mg dose and over 40 patients currently in screening to initiate 700 mg dose arm of monotherapy trial. The FDA also gave CytoDyn permission to upgrade all ongoing patients who are currently on 350 mg in the combination therapy to 700 mg dose.
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