Kmall’s been telling about these guys all along

[biopearl123]

https://ir.geron.com/investors/press-re ... fault.aspx

[rccola335]

not only more J n J / Janssen talent but worked on Imbruvica, imetelstat should be right in their wheelhouse

[kmall]

Fantastic news, but not exactly new to any of us paying attention here on Imetelchat. I'm from the school of thought and reason where every employee of a company has an integral part to play in the success of that company. From the top all the way down to supportive positions, they all help to keep the wheels in motion while striving for an end goal. This one being the eventual approval and commercialization of Imetelstat. We can certainly start to see that goal coming to fruition over the horizon.

Nishan Sengupta* was discussed at length on Imetelchat as far back as July of this past year.

viewtopic.php?f=1&t=1340

His experience as Global/US Access Strategy Lead-IMBRUVICA at JNJ is an enormous positive for Geron moving forward.

*Nishan Sengupta was NOT employed by JNJ while at Geron, so please excuse that posting for any misinformation. His profile on LinkedIn had him listed as being at JNJ while at Geron. It took a few months to clarify, but once brought to Aron Feingold's attention it was promptly corrected. Thanks again Aron! ,-Kmall

[biopearl123]

I have to say that this press release struck me as a little be odd. Why trumpet that your sales force is in place a full year before you plan for market release? Sounds like a mixed message to me and one that suggests market release date of 2024 is very conservative and subject to change.

[rccola335]

the ImpactMF had the first patient enrolled 4/21 and is still open. With the life expectancy of patients in the control arm expected to be so poor there should start to be separation between the two groups being seen now. Once statistical significance is achieved with a high level of confidence I can see approval for MF early due to ethics of denying people effective treatment for such a dire circumstance. The safety profile was confirmed in the MDS trial ( including QT interval ). This all hinges on how quickly they got a signifanct number of patients enrolled in the ImpactMF trial. I think this is why we may have seen such a large ramping up of staffing due to this possibility. There is the potential to see imetelstat on the market for MDS and MF in 2024.

[kmall]

rccola335 - Interesting point that you bring to the table, and may somewhat explain why Geron has subcontracted out helping to fulfill patient enrollment in Europe for P3 IMpact to TMAC - The Medical Affairs Company? About 2 months ago, we discovered two employees:

Chiara Elia - Clinical Trial Liaison for Geron Corporation in Italy, Austria, Germany Switzerland and Denmark
The Medical Affairs Company (TMAC)
Modena, Emilia-Romagna, Italy


Belén Castillo - Clinical Trial Liaison at The Medical Affairs Company (TMAC) for Geron Corporation

Barcelona, Spain

http://imetelchat.imetelstat.eu/viewtop ... f=1&t=1425

....who are working on behalf of Geron.

Belén Castillo also works in Latin/South America for TMAC. -Kmall

-Kmall

[rccola335]

it was September 2018 when Janssen listed imetelstat for compassionate use - it didn't list what disease it was for but it had to be for MF - The last presentation had 1.3 bilionl sales for MDS and 1.8 billion for MF - 3.1 billion for the two indications - we have the potential for substantial stock price increases over the next year or two

[biopearl123]

Here’s the problem I have with that reasoning. I too have been hoping for some sign we would see “earlier” MF data. Geron has always guided when the 50% enrollment milestone was met. As far as I know this has not happened in IMpact MF. This means that the 160 mark (total enrollment anticipated at 320) has not yet been met. They also need to reach 35% total enrollment number of deaths, or 112 before making data public (unless the FDA suddenly develops a conscience). Reaching this allows for a “first look” at survival curves and is guided to occur in 2024. Reaching the 112 death mark does not require full enrollment and could actually occur at any time. Because the study is not blinded I agree it is very likely that Geron has a very good idea what the Kaplan Meir curves look like and I think that is what is driving the current optimistic spend and hiring pattern. An unknown to me is how the “cross over” from control to drug guided by pretty strict criterion affects these curves and OS expectations. I have asked but not received a decipherable answer. At full enrollment the control group would have 96 patients. Most of these patients would have either died or crossed over to study drug. I suppose this design is Geron’s version of “compassionate use.” I also don’t think that even if Geron knows what the Kaplan Meier curves look like present day, they could share this information with a potential buyer without violating insider information rules. That would be a disaster. But by telegraphing dramatic spending and hiring they are in effect telegraphing just how good the current closely held information actually is. This is of course speculation on my part but why I don’t think we will see IMpact MF data until they have guided that we will. bp

[biopearl123]

Rccola335, As to the QT interval study, as far as I know, those results have not been made public except by omission. If they were bad we would know.

[rccola335]

Agree - if we have not hit the half way enrollment that will slow things down - surprised enrollment is so slow when these patients have no other options

[biopearl123]

I actually think enrollment in all the ongoing active studies will be helped as the highly significant findings in IMerge are more widely known. Patients should be demanding to get into these studies and physicians should be facilitating their enrollments.