Look for the Continuation Decision next week

[biopearl123]

Hoping for some important news delivered during the next quarterly update on next Tuesday. While Geron can't control the timing of an FDA change in drug status (e.g. AA), I believe they would time the conference call to coincide with a Janssen decision. It will have been three months since the MF trial completed and also even more time since the "new" 25 MDS patients could be evaluated for 8 week TI (at a minimum). So clearly Janssen has what it needs to decide to continue or not. This would be an obvious time to say so. bp

[j6proulx]

I share your opinion that I expect the continuation decision in the near future. This week will be three full months since the primary analysis began for IMbark. We know that Janssen has to complete the primary analysis and also submit a clinical development plan for Geron's consideration of whether to opt in.

I also suspect Janssen is pursuing accelerated approval for imetelstat in MF based on the IMbark primary analsys and results of the recently completed Mayo study. To get a sense of what's involved in requesting NDA approval, I researched clinical study reports submitted for approved drugs. The FDA recently instituted a pilot program for data transparency with drug approvals. Janssen was the first company to participate, with its Erleada being the first drug approval in the pilot program. Erleada's clinical trial protocol, clinical study report, approval letter, FDA correspondence, etc., are all available on the FDA's website: https://www.accessdata.fda.gov/drugsatf ... 51_toc.cfm . I see this as a window into the details and scope of information associated with FDA approvals.

I suspect the three months from April 26 start of the primary analysis is sufficient time to complete this work. If Janssen has been working on the clinical development plan concurrently, the company would be in position to make its continuation decision very soon. I am anxious to learn what additional indications are identified and I hope this information is made public. Best wishes to all.

[cheng_ho]

I looked and I looked but I couldn't find the CD

...is JNJ actually going to sit on this until Sept 28th?

[biopearl123]

Cheng, Very funny, very funny. I looked too and couldn't find it, must just be looking in the wrong place (or the wrong time). bp