Replies to post #117114 on Biotech Values

[DewDiligence]

ARIA—Dew threw around the HR ~0.85 threshold (if i remember correctly). At first glance that sounds reasonable, but I wonder if the FDA will necessitate a higher mental threshold just due to the open label nature of the study.

I would think a hazard ratio <=0.85 for OS on an ITT basis combined with statsig PFS (the primary endpoint) ought to be sufficient. If results that good turned out to be inadequate, the FDA would be making a mockery of calling PFS the primary endpoint.

[ariadndndough]

pgs or biomaven with today's news does this mean that aria and doctors will be able to test pts with CML and ALL and know right away if they have this mutation. which means these pts will start right on pononatib instead of the other first line therapies. which increases there market share right away???????

thanks

dough