Short answer on safety data, end of July to end of
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Posted On: 07/17/2019 4:26:20 AM
Short answer on safety data, end of July to end of August is my estimate. I believe that is all they are waiting for with the BLA Clinical Part with maybe also determining the dose given using the ccr5 density test.
Long answer.
For the safety data, they need 100 patients on 700mg for 24 weeks. We also learned from misiu‘s question in the last cc that at least 50 must start at 700mg, some of the other 50 could have switched from a lower dose failure.
On feb 1, 24 weeks ago, they gave in part this below, stating they had 74 on 700 mg on mono with 40 more in the pipeline to start the 700mg arm. They total number of patients that was ever on leronlimab kept jumping in press releases. So it is very likely they hit the 100 number February to early March. It looks from their latest Poster, they continued to enrolled another 60 more in addition to the 40 some time between March and June. So they should have the safety data, some time between end of July to and end of August. I’m guessing they hit 100 mid-February, but any failures before 24 weeks would not count. Also, one other interesting item, they switched the combo patients to 700mg. So, they actually did have 100 patients on 700mg on Feb 1st, but I don’t believe they are allowed to use the combo data.
Long answer.
For the safety data, they need 100 patients on 700mg for 24 weeks. We also learned from misiu‘s question in the last cc that at least 50 must start at 700mg, some of the other 50 could have switched from a lower dose failure.
On feb 1, 24 weeks ago, they gave in part this below, stating they had 74 on 700 mg on mono with 40 more in the pipeline to start the 700mg arm. They total number of patients that was ever on leronlimab kept jumping in press releases. So it is very likely they hit the 100 number February to early March. It looks from their latest Poster, they continued to enrolled another 60 more in addition to the 40 some time between March and June. So they should have the safety data, some time between end of July to and end of August. I’m guessing they hit 100 mid-February, but any failures before 24 weeks would not count. Also, one other interesting item, they switched the combo patients to 700mg. So, they actually did have 100 patients on 700mg on Feb 1st, but I don’t believe they are allowed to use the combo data.
Quote:
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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