Replies to post #3899 on Halozyme Therapeutics Inc (HALO)

[friendofthedevil]

The next PR out of HALO should have to do with the HA diagnostic. It will likely be the crux of all future trials. They need to get it right. It should be easy to use and relatively cheap so that any path lab can make this test available to their surgeons and oncologists. To do this right may require partnering with a diagnostic company who can easily make this available to every tumor board. I would guess this is the main reason Ph3 starts in 2016.

[rod5247]

FOTD, the notification deadline for acceptance of late breaking is today. Looking like interim on 202 was accepted. What are your thoughts?


Late-Breaking Data Submissions


The ASCO late-breaking data policy allows for the submission of late-breaking data only for randomized phase II and III trials for which no preliminary data are available at the time of the abstract submission deadline (February 3, 2015), but for which a preplanned analysis of the primary endpoint is scheduled after that date but before April 1, 2015 (the deadline for the final, updated late-breaking data). During abstract submission, you will be required to provide the primary clinical endpoint for analysis, type of analysis, date of planned analysis, and planned statistical methods for analysis. The policy is not a mechanism to allow for updated data to be submitted later when preliminary data are available by the abstract submission deadline.

Late-Breaking Data Submission Guidelines

In order for an abstract to be considered for late-breaking data submissions status, the first author must

•Submit an abstract, excluding Results and Conclusions sections, by the abstract submission deadline (February 3)
•Adhere to the confidentiality policies
•Adhere to the biostatistical guidelines for phase III trials, with the exception of the Results and Conclusions sections
•Describe the type of data that will be submitted by the late-breaking data submission deadline, indicating the primary clinical endpoint for analysis, planned statistical plan for analysis, and date of planned analysis. (For example, “Survival data for the two treatment arms will be compared using a log-rank test.”) In general, ASCO discourages reporting of interim analysis results, unless approved by the study’s Data and Safety Monitoring Committee.

The final, updated late-breaking data submission must be submitted by April 1. If an updated abstract with data and analyses is not submitted, the abstract will be automatically withdrawn.