Current 1Q18 MF median OS review and related upcoming reporting

[huntingonthebluffs]

This is an email question to Anna Krassowska, Geron IR and her explanation responses. While I think most are hoping for some specific details in near term communications, knowing the data has still not matured continues to be helpful. As basically all of us are hopeful for our friends and family and as investors that Geron, JNJ/Jansen and the FDA will find in the data review the reasons mandating a positive detailed update and possibly early approval. However continuing with the thought that more mature data is required, continues to be very positive. Anyway, so while not providing any additional “new” news I felt this might still be of interest to the ImetelChat board and those who can provide any additional thoughts or insight around Anna’s responses.
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Initial Email question:

Dear Anna,
Given that we investors believe the majority of their Geron investment and future is apparently now riding on the outcome of the OS results in the MF trial being reviewed in 1Q18. Hopefully we will be told the number of months over the median, the number of patients still alive versus total. Of course any numbers on CR, PR or CI’s would be greatly appreciated as well.
Can you provide any insight now on what we could expect in the coming weeks regarding press releases, conference calls, etc. and the information expected to be provided describing CT results to date? Otherwise, our frustration regarding the data desert continues to the detriment of investors and hopeful family and friends with MF, MDS, ET, MM, etc. diseases. Thank you for reading and hopefully responding on all points not affecting competitive advantage.
Best regards,

Anna’s initial reply:
Thank you for your email.

The IMbark Q1 data review is not the primary analysis. Investors should not expect results from IMbark to be presented following the Q1 data review, primarily because the OS data, which are an important component, are not expected to be sufficiently mature. May I also ask what you mean by the statement “number of months over median”? I ask because I am sensing a potential misunderstanding that I think might be important.

Best regards,
Anna

Clarification of email question:
Dear Anna,

Thank you for your quick reply, very much appreciated!

I do apologize for my scrambled thoughts. I can try to explain hopefully more clearly by saying, various reports and blogs and listening to Dr. Scarlett’s presentations indicate that JNJ’s study of median OS indicates approximately 7 months and MD Anderson Cancer Center 14 months. I believe approximately 12 months is Dr. Scarlett’s latest conservative target of existing median OS for R/R MF patients. So what I was attempting to ask was how many months past Dr. Scarlett’s median OS target are we currently regarding the IMbark trial. Also, if possible, it would be extremely reassuring to know how many patients and / or percentage are still alive assuming that information is available for investors and those suffering from MF following the 1Q18 review?

Now I do appreciate your dilemma with communicating median OS, as there are likely many disease characteristics involved and considered along with the staggered entry into the CT, etc. At this juncture, knowing that median OS hasn’t been reached continues to be reassuring for all of us and our families, which is what I believe you are saying with the terms “not expected to be sufficiently mature”. I am hoping (requesting if possible) that some details will be provided in the near term communications around the fact that the data is not yet sufficiently mature. Thanks again for your feedback and contributions.

Best regards,

Anna’s reply:

Thank you for taking the time to write such a detailed response to my question. Please do not apologize. I thought that is what you probably meant, but I just wanted to be sure. I interact with investors from all different backgrounds!

In general terms, estimating expected survival in a patient population is challenging. And this is especially true in a population that has never really been studied in a clinical trial setting. We have described survival estimates that have been published, as you cited in your email. A major caveat is the extent to which the patients enrolled in a clinical trial actually correspond to or match the patients in a “historical” population. This is why, as you know, to truly assess the improvement in survival resulting from a drug treatment one conducts a randomized, controlled trial. IMbark is not such a trial. Of course, one can make estimates based on the available information and use those estimates to guide decisions about further development.

I understand that investors and patients are interested to see the current survival data from the ongoing trial. However, such data can be misleading before being sufficiently mature – I like to use the analogy of tasting the raw cake batter in order to know how the final baked product will turn out.

We have guided investors that they should not expect results to be reported following the Q1 data review. As with the other data reviews, we expect to update investors if there are any changes to the conduct of the trial, or if there is an update on timing for the primary analysis, based on the number of deaths. But not the data itself.

This answer may not be satisfying, but I hope that it is informative and helpful.

Your support of Geron, and your personal interest in success of drugs, including imetelstat, for the treatment of patients with these devastating diseases, is truly appreciated.

Warm regards,
Anna

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[Dogonenuts]

It is a shame that all the info in these CTs has to be so closely guarded. Seems there should be some mention of numbers of original pts still in the trials and reference to their initiation in the trial. This should be fair game as we know the OS for r/r patients is short.

Nuts

[biopearl]

Dog, I completely agree, we should at least be apprised as to how many patients remain in study and on drug. Fish, thanks for trying to get further info. That the normally subtle and subdued Anna has become voluable may be no accident and may presage a more open approach to investors, that would be welcomed. This last “short sighted” SA article was hilarious and a sure buy sign delivered by the desperate. bp

[Fishermangents]

Credits go to huntingtonthebluffs, who actually had the conversation with Anna.

Anna tried to protect us from having to high expectations regarding the level of detail we can expect from the next update. So I think we really need to wait and see, as Anna didn't really clarify a lot. She is not in the position to do so, as the answer on the questions regarding OS and deaths can only be answered when ready and agreed by JnJ. She can't do that upfront by herself, in a single email to an investor. In addition, we don't know much about the ongoing discussions between JnJ and FDA. And for sure, everything that is being said there is strictly secret and probably not even known to Anna. Given the recent FTD I assume that these interactions are still going on.

[biopearl]

Sorry hunt I initially didnt not realize you were the author of the query to Anna. That’s the most detailed reply I have seen. Thanks for your efforts. Honestly, the reply was a little disingenuous in that while yes OS data has not matured, surely surrogate data must be plentiful. CRs, PRs CIs to start, anemia, molecular responses symptom scores as well. Cake batter indeed. The study is due (as of now) to have top line data completion May (three months), I’d say that cake was about ready to come out of the oven to be frosted. bp

[Dogonenuts]

Does anyone here know if Irishtrader’s husband, John, was able to get back on Imet, or is still with us in life? I sure hope so, but have not seen an irish post in a long time, so I amfearing the worst for them. This stuff goes way beyond investing.

[Fishermangents]

Unfortunately, John passed away last year. I suppose irishtrader lost her motivation to post. I am not aware of the details regarding his imetelstat treatment, only that he wasn't on the drug anymore for a while.

[Dogonenuts]

Ah, I was afraid of that. We all will pass one day, but I would hate to think that the trials caused him to come off of the drug when it was helping him, and led to his passing.