I feel that the forum has been focusing lately on the past and maybe its a good time to redraw to future map of Imetelstat and Geron,
i am listing some guideline questions and ask for everyone to contribute their knowledge and estimations:
Geron as an independent company:
is it only a waiting game for JNJ or Geron may plan to do something more ?
can someone suggest an evaluation model for the company in its current position ?
what should shareholders push the company to do besides just wait ?
Imetelstat trials:
besides the JNJ continuation decision, what is the expected roadmap ?
can we profile past JNJ continuation decision processes and forecast timing ?
what other cancer candidate drugs does JNJ have and in what clinical stage ?
Science: (my favorite)
what are the latest discoveries in regards to Telomerase and Telomere (cancer context) ?
other current molecular approaches for treatment of blood cancer ?
you all are invited to contribute
moving forward
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- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
Re: moving forward
Ido,
Your worthy post has been viewed many times with nary a reply yet. I think the reason is that the post's subject it too broad to know where to begin.
As a 14 year Geron long, I have found the Imetelstat story compelling for numerous reasons.
One of the most exciting story lines "moving forward" for me are the many, many potential off-label Imetelstat uses that hematology/oncology will practice once the drug is approved,
Build0277
Your worthy post has been viewed many times with nary a reply yet. I think the reason is that the post's subject it too broad to know where to begin.
As a 14 year Geron long, I have found the Imetelstat story compelling for numerous reasons.
One of the most exciting story lines "moving forward" for me are the many, many potential off-label Imetelstat uses that hematology/oncology will practice once the drug is approved,
Build0277
-
Fishermangents
- Site Admin
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Re: moving forward
Hi Ido, you raise all good points. I'll try to address some. (please note: these are just personal opinions and shouldn't by any means being interpreted as some kind of advice. Everybody has to do his/her OWN DD and based on that, take his/her OWN decision)
Waiting game
I think that it partly is a waiting game, mainly for us shareholders and also a bit for Geron. However, with JnJ proceeding to P3 with IMerge and presenting their whole imetelstat program to the FDA doesn't give me the impression that JnJ is in the waiting mode. We should also not forget that JnJ is sponsoring 'numerous pre-clinical studies', off which the venetoclax-imet combo paper is an example which they have made publlic (co-authored by 10-JnJ employees, of which one VP).
The key point is the fastest way to approval. It will be probably one of the topics of JnJ's agenda with the FDA. Once that path is clear (which means that JnJ and FDA are on the same page) we may see more movement.
For Geron this is a ballancing act, because they are not in the driving seat, but yet need to properly inform investors while making sure they can keep funding their operations. Although some try to make us believe that JnJ already 'owns' 80% of Geron, this is simply not true. They have a license. The whole game will soon focus around the fact that JnJ doesn't own Geron yet and will need to take a decision on what relationship with Geron would be the best for their business and the cooperation with Geron itself.
Continuation decision
This already has caused a lot of discussion, because this is wrapped in interdependent factors, of which we don't know how they individually will work out. One is the unwinding of IMbark: will it proceed? If yes: how? Will it be ended, e.g. because there are sufficient data regarding the R/R MF sub-group of patients? Will there be some kind of fast track for this patients group? There are some good reasons to believe IMbark goes into such direction. From HOOSIER (SA):
'Now our conservative CEO is publicly stating the recent IMbark data review suggests both a CLINICAL BENEFIT and an OVERALL SURVIVAL BENEFIT in this R/R patient population with an unmet medical need.'
In addition, if IMbark wasn't sufficiently showing 'encouraging trends' JnJ would have pulled the plug after their latest review.
However, if IMbark will be ended for some reason or significantly delayed, a continuation decision must be taken by JnJ not later than 24 months after the start of IMerge (i.e. January 2018). IMerge, as we know, goes very well, as it keeps replicating earlier Mayo results regarding safety and efficacy. And JnJ is going to propose some 'refinements' to the protocol to the FDA. So I guess a P3 is imminent, starting patient enrollment in Q4 2017 (source: Geron). But IMerge itself doesn't trigger a continuation decision on its own. Although the 10-K from 3/1/2017 says that a decision by JnJ on the Collaboration Agreement is expect in Q2 2017, the reality may be different in the meanwhile. HOOSIER (SA):
'We know from the recent update that Janssen is planning to monitor the existing IMbark patients for another year. That tells me the primary analysis of the IMbark trial should be complete in 2Q18. Janssen's continuation decision is likely required as part of (or shortly after) the primary analysis.'
Roadmap
A crystal ball would be nice here. But this is what I think to be a possible in an optimistic, but nevertheless realistic scenario for 2017:
- some kind of fast track for high risk MF R/R patients group
- IMerge goes to P3, patients enrollment starts Q4 2017
- Announcement of AML combo trial (venetoclax + imetelstat)
Just my opinion, alternative viewpoints are appreciated.
Waiting game
I think that it partly is a waiting game, mainly for us shareholders and also a bit for Geron. However, with JnJ proceeding to P3 with IMerge and presenting their whole imetelstat program to the FDA doesn't give me the impression that JnJ is in the waiting mode. We should also not forget that JnJ is sponsoring 'numerous pre-clinical studies', off which the venetoclax-imet combo paper is an example which they have made publlic (co-authored by 10-JnJ employees, of which one VP).
The key point is the fastest way to approval. It will be probably one of the topics of JnJ's agenda with the FDA. Once that path is clear (which means that JnJ and FDA are on the same page) we may see more movement.
For Geron this is a ballancing act, because they are not in the driving seat, but yet need to properly inform investors while making sure they can keep funding their operations. Although some try to make us believe that JnJ already 'owns' 80% of Geron, this is simply not true. They have a license. The whole game will soon focus around the fact that JnJ doesn't own Geron yet and will need to take a decision on what relationship with Geron would be the best for their business and the cooperation with Geron itself.
Continuation decision
This already has caused a lot of discussion, because this is wrapped in interdependent factors, of which we don't know how they individually will work out. One is the unwinding of IMbark: will it proceed? If yes: how? Will it be ended, e.g. because there are sufficient data regarding the R/R MF sub-group of patients? Will there be some kind of fast track for this patients group? There are some good reasons to believe IMbark goes into such direction. From HOOSIER (SA):
'Now our conservative CEO is publicly stating the recent IMbark data review suggests both a CLINICAL BENEFIT and an OVERALL SURVIVAL BENEFIT in this R/R patient population with an unmet medical need.'
In addition, if IMbark wasn't sufficiently showing 'encouraging trends' JnJ would have pulled the plug after their latest review.
However, if IMbark will be ended for some reason or significantly delayed, a continuation decision must be taken by JnJ not later than 24 months after the start of IMerge (i.e. January 2018). IMerge, as we know, goes very well, as it keeps replicating earlier Mayo results regarding safety and efficacy. And JnJ is going to propose some 'refinements' to the protocol to the FDA. So I guess a P3 is imminent, starting patient enrollment in Q4 2017 (source: Geron). But IMerge itself doesn't trigger a continuation decision on its own. Although the 10-K from 3/1/2017 says that a decision by JnJ on the Collaboration Agreement is expect in Q2 2017, the reality may be different in the meanwhile. HOOSIER (SA):
'We know from the recent update that Janssen is planning to monitor the existing IMbark patients for another year. That tells me the primary analysis of the IMbark trial should be complete in 2Q18. Janssen's continuation decision is likely required as part of (or shortly after) the primary analysis.'
Roadmap
A crystal ball would be nice here. But this is what I think to be a possible in an optimistic, but nevertheless realistic scenario for 2017:
- some kind of fast track for high risk MF R/R patients group
- IMerge goes to P3, patients enrollment starts Q4 2017
- Announcement of AML combo trial (venetoclax + imetelstat)
Just my opinion, alternative viewpoints are appreciated.