ImetelChat

For discussion, after the JnJ Q3 Report:

Links to the JnJ Q3 presentation:
http://seekingalpha.com/article/4012737 ... all-slides
http://files.shareholder.com/downloads/ ... peline.pdf

by MedTechBio, SA 19 October 2016:
Whoa, I almost fell off my chair. Page 45 has MF frontline Imetelstat filing in addition to the R/R. We all knew that was likely, but first time JNJ or Geron published this that I can recall.

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by CuriosityKilledTheCat, SA 19 October 2016:
Janssen's intention to file for frontline MF was publicly disclosed as far back as May 20, 2015, during it's Pharma Analyst's Day conference:
http://files.shareholder.com/downloads/ ... _Final.pdf
On page 206 of the presentation, Imetelstat is listed as a "planned filing" 2015-2019 in MF R/R and MDS low/intermediate risk and under "Selected Early To Mid-Stage Pipeline (filing expected beyond 2019) one can find MF frontline, MDS high risk and AML R/R.

What has changed according to the new presentation is imetelstat's lead indication MF R/R is now expected to be filed in 2018 (follow magic's link to page 33) whereas filing for that indication was originally anticipated to occur in 2017 (follow the above link to page 221). However, what also has changed is the anticipated filing date of MF frontline. As I note above it was originally anticipated to occur beyond 2019 and now is expected to occur sometime before 2019 (magic's link to page 45). What this change tells me is Janssen has prioritized MF frontline (vs. AML R/R and MDS high risk). It also tells me to expect an announcement in the not-too-distant future of the start of the MF frontline trial.

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Any opinions here?

Fish, have posted a response on SA, if you think it is relevant please feel free to repost it here. Regards, bp

Bio, nice response. There are also a couple nice responses to your comment. So I would encourage people to go to SA in order to read them all.

It would be interesting to know if Dr. Tefferi would be excited about a MF frontline study versus the current R/R study. Referring to his comments in Italy.

CT site now shows update to MDS study. One German site has withdrawn. The study completion date has been pushed out to 2020!!! I guess the good news it that it is likely enrollment will be restarted next year. What is peculiar is that they did not take the opportunity to show the study as suspended but continue to show it as enrolling. This is contrary to Dr. S update and may reflect the delay we are so so used to re CT site but maybe they changed their minds? Seems doubtful with out a press release. Of course they are looking for longevity so pushing out the completion date may not slow application for approval at some earlier time. Can anyone may more sense out of this? Regards, bp

see other thread for MDS update.