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Posted On: 07/15/2020 12:35:19 AM
Post# of 153988
“maybe yesterday in the call, that Cytodyn planned to obtain approval for leronlimab with a Supplementary NDA once the combo therapy was approved.”
There has been speculative discussion about this topic for a number of months. Fortunately, someone asked NP the question during a recent CC and NP said clearly, “No, a phase 3 will be needed to approve leronlimab for monotherapy.”
Monotherapy, in my opinion, is at least 18 months away. They have yet to start the trial, which will most likely be a year long (but hopefully shorter). The big focus was on cancer and the combo BLA, but once COVID came along, mono got shelved temporarily. The company should have the money now to run the mono trial, so hopefully it gets started ASAP.
There has been speculative discussion about this topic for a number of months. Fortunately, someone asked NP the question during a recent CC and NP said clearly, “No, a phase 3 will be needed to approve leronlimab for monotherapy.”
Monotherapy, in my opinion, is at least 18 months away. They have yet to start the trial, which will most likely be a year long (but hopefully shorter). The big focus was on cancer and the combo BLA, but once COVID came along, mono got shelved temporarily. The company should have the money now to run the mono trial, so hopefully it gets started ASAP.
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