Clarifications from Anna (Geron) regarding 4.7 and 9.4 arms

[Fishermangents]

(received 19 September 1016, based on some questions I had sent to her before)

Thank you for your feedback, it is always appreciated.

I would like to clarify a couple of points.

Enrollment of new patients to the 9.4 mg/kg arm has been suspended, while the trial continues in order to obtain additional and more mature data that includes a longer follow-up of patients at 24 weeks, consistent with the co-primary efficacy endpoints.

Furthermore, enrollment of the 9.4 mg/kg arm is not completed by patients enrolled on the 4.7 mg/kg arm being given the opportunity to increase their dose to 9.4 mg/kg. And note that this will be at the discretion of the investigator at each site, pending an amendment to the clinical trial protocol. And, these two arms would likely be analyzed independently, as they have been treated differently.

We are indeed encouraged by the emerging trends in IMbark and IMerge, and we wait for the longer term follow-up data from both studies.

Do let me know if you have additional questions.

Kind regards,
Anna

[Fishermangents]

Intersting: the to arms 'likely be analyzed independently'. So it is not 100% sure they will. She also says implicitely that the former 4.7 arm will stay part of the trial. That means that all original cohort of patients are staying on the trial.

[biopearl]

Thanks Fish, the word indeed is edifying. bp

[robtmsstt1]

Ask Anna what "emerging trends" actually signify my interpretation of this statement says the patients are feeling better or there are signs the drug is working .

[Fishermangents]

Rob: that remains guessing, because they won't tell. They didn't tell it in the cc, not in the press release and not in the answers of the various questions. My guess is that we have to look into hematological responses (lower LDH, less inflammation, improved blood counts etc.). I don't think they will look at bone marrow after just 12 weeks, because that's quite invasive. The answer is probably hidden somewhere between the long list of secondary outcomes of the trials.

[biopearl]

Fish, it could be as simple as spleen and symptoms. Just not enough yet. bp

[robtmsstt1]

Thanks, fish looking forward to start of AML study.

[Fishermangents]

Bio: indeed, it could. But I believe it was said that the internal interim review was not looking at the primary end-points, after an analyst asked for the criteria.

[biopearl]

Thanks Fish, I missed that when I listened to the cc. bp