Great news and I'm really looking forward to Thurs
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Posted On: 09/09/2019 2:34:05 PM
Great news and I'm really looking forward to Thursday's call.
My guess on the BLA is FDA doesn't want to approve a specific dose, but that the Receptor Occupancy Test (ROT) will determine dose (350 mg, 525 mg or 700 mg). This would personalize the medication and falls in the lines of the FDA working with us for both combo and mono. This would likely require them to compile the clinical and CMC data for 700 mg (which NP has previously has said if FDA required 700 mg it may be October for BLA). If they go with personalized dose, I am not sure what all this means for manufacturing, commercialization and distribution, but that at least CYDY would get revenue from the ROT......this may also make a merger between CYDY and IncellDX more fitting, but I am not sure of other IncellDX products align? Not that I am hoping for this, but it takes a backseat to every other license, partnership or deal that involves cash at this point.
If leronlimab works on all metastatic cancers, Humira is not an exaggeration at all and maybe even underestimating the value........but since the world doesn't know anything better yet and we are sitting at $.3925 it seems crazy. Best of luck!
My guess on the BLA is FDA doesn't want to approve a specific dose, but that the Receptor Occupancy Test (ROT) will determine dose (350 mg, 525 mg or 700 mg). This would personalize the medication and falls in the lines of the FDA working with us for both combo and mono. This would likely require them to compile the clinical and CMC data for 700 mg (which NP has previously has said if FDA required 700 mg it may be October for BLA). If they go with personalized dose, I am not sure what all this means for manufacturing, commercialization and distribution, but that at least CYDY would get revenue from the ROT......this may also make a merger between CYDY and IncellDX more fitting, but I am not sure of other IncellDX products align? Not that I am hoping for this, but it takes a backseat to every other license, partnership or deal that involves cash at this point.
If leronlimab works on all metastatic cancers, Humira is not an exaggeration at all and maybe even underestimating the value........but since the world doesn't know anything better yet and we are sitting at $.3925 it seems crazy. Best of luck!
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