Since the FDA seems to be busy these days, not sur
Post# of 148292
Quote:Although I can't tell you the exact event, or if he was referring to the BTD or another trial endpoint, but sometime within the last 2-3 calls I very clearly heard Dr. NP say the FDA was looking for 6 months of PFS (progression free survival). We don't really know if that meeting took place. Maybe that comment only referred to the 22-Solid Tumor Basket Trial.
Since the FDA seems to be busy these days, not sure when the preliminary meeting will be or how long FDA has to respond.
In any case:
Quote:This performance bump sunsets on July 28, 2020. With the global clinical trial delays associated with COVID, this date may pass without a BTD -- unless the board agrees to extend the date due to unforeseeable circumstances.
On January 28, 2020, the Company awarded 11,650,000 performance shares to certain of its directors and executive officers outside of the 2012 Plan. The awards will vest and be settled in shares of common stock of the Company if the Company achieves FDA Breakthrough Therapy designation for cancer within 6 months of the award date and if certain other requirements have been met