Replies to post #3528 on Halozyme Therapeutics Inc (HALO)

[maumar]

I was not aware it is an open label study. Wouldn't a lot of people besides Halo - doctors, patients, relatives, etc.- know how things are going? Or is it too early?

[rod5247]

Not only open label but the patients in first year did not continue with new protocol. That part of the study finished dosing in April. Dr. Torley stated, while the data will be useful, it will not be included with data from current study.

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.

[rod5247]

Not only open label but the patients in first year did not continue with new protocol. That part of the study finished dosing in April. Dr. Torley stated, while the data will be useful, it will not be included with data from current study.

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.