Quote:

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Decrease in Circulating Tumor Cells (CTC) as reported using the LifeTracDx™ test developed by Creatv MicroTech, Inc., after induction with leronlimab was associated with a 400%-660% increase in mPFS (modified Progression Free Survival)/12-month PFS (Progression Free Survival) and a 570%-980% increase in mOS (modified Overall Survival) /12-month OS (Overall Survival). Decreases in CTC after leronlimab induction were seen in 73% of the 30 patients in the study. LifeTracDx™ appears to aid as a parallel diagnostic tool in identifying patients that respond to leronlimab.

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So, we can increase mPFS and mOS way beyond approval threshold AND can identify who will respond to treatment (which happens to be majority of patients).

Quote:

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CytoDyn plans to update its Breakthrough Therapy designation application and file for BTD for mTNBC

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Can't wait for BTD to be filed.

This, my friends, is what we have been waiting for ... this indication is HUGE if it pans out and the data seem to point in that direction. The reported mPFS and mOS improvements are just excellent to put it mildly.

Best news we can get.