Saturday, October 04, 2014 5:16:43 PM
Halo presented enough data to the FDA to get hold lifted and Fast Track designation and that was over 90 days ago.
If memory serves, the upcoming presentation was accepted as late breaking oral presentation. I don't see how preclinical and Peg/Gem can be late breaking or qualify for an oral presentation.
Ab/Gem has a median PFS of 5.5 months, median OS of 8.5 months and ORR of 23%. PAG study started April 2013 with an 8 patient lead in, 43 centers recruiting by July 2013 and halted April 2014.
While I do not know that anything from Phase II will be presented at this time, I do believe they have enough data to present and at some point, it will be.
Dr. Frost stated last year that interim data would not be released in order to preserve the integrity of the data. Were they thinking of applying for fast track on completion and the hold opened the door early.
The data was good enough for a Fast Track designation and a new protocol with 2:1 ratio for study drug. The FDA saw the data and had enough to make these decisions.
I absolutely agree, if this were interim data, it would not be released.
Never argue with a fool, for after awhile, it becomes difficult to determine which is the fool.
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