So this thread is to collect hypothetical questions for the cc of tomorrow to see afterwards which ones have been addressed and which haven't.
My questions would be:
- Can you confirm the intention of JnJ to file imetelstat for Frontline MF in 2019?
- If yes: when do you expect the Frontline MF trial to start?
- In the past it was said at various occasions that an AML trial would start H2 2016. Is this still the case or is there a change of plan?
- Regarding IMbark: as patients can stay on the 4.7 dosing arm, can we conclude that patients do experience benefit at that dose?
- If yes: how would you describe that benefit?
- Recently a second license agreement was closed between Geron and JnJ. When providing licenses there mostly are expectations to be met by the licensing party regarding the expected revenues on short, mid and long term. How did you estimate the revenue potential of this agreement?
Questions for 3 Nov 2016 cc
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- No commercials/harassment/spam
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Fishermangents
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Re: Questions for 3 Nov 2016 cc
Great start. I would add: 1. How many patients are alive and on drug from the original pilot study. 2. Since this study continues can any extrapolations regarding longevity be made? 3. Are there plans for use of imetelstat in combination with other medications and for what indications? 4. Can you provide background for the change in the MF protocol that drops secondary MF as an entry criterion. 5. Have molecular markers of drug effect been confirmed in the Janssen MF and MDS studies? 6. There has been an increase in the number of patients for the 9.7 arm from 100 to 150, what is the reasoning for this change? Are more patients required to reach statistical significance than originally thought? Fish I really like your question list. I predict that the MDS molecular data will be submitted for a late breaker at ASH but we won't know until the end of November about the late breaking abstract titles. Regards, bp
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huntingonthebluffs
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Re: Questions for 3 Nov 2016 cc
I would be very interested in knowing the following:
1. Why did JNJ opt to do the MF R/R study first versus frontline and when do you expect the frontline study to begin?
2. Thousands of hemo patients are hoping to have access to Imetelstat, extending the trials is alarming to them. Can you please outline the reasons for extending the clinical trials?
3. Are there any reasons to not pursue BTD, FTD, etc. and an accelerated approval on a “short game” strategy in conjunction with the current “long game” strategy?
1. Why did JNJ opt to do the MF R/R study first versus frontline and when do you expect the frontline study to begin?
2. Thousands of hemo patients are hoping to have access to Imetelstat, extending the trials is alarming to them. Can you please outline the reasons for extending the clinical trials?
3. Are there any reasons to not pursue BTD, FTD, etc. and an accelerated approval on a “short game” strategy in conjunction with the current “long game” strategy?