compassionate use program?

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Zhears
Posts: 74
Joined: Mon Oct 08, 2018 12:19 pm

compassionate use program?

Post by Zhears » Wed Nov 14, 2018 11:12 am

When JnJ added imet to their compassionate use program, was this acknowledged as a mistake?

Or was it added because it was needed and then removed due to the business decision.

If we assume that it was a business decision that forced it being taken down, should geron be providing access to this under a similar program?

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: compassionate use program?

Post by biopearl123 » Wed Nov 14, 2018 3:47 pm

Zhears, it was never acknowledged as a mistake. If it was a mistake it was a cruel one. It appeared to be a genuine anticipation of approval at the time. What happened after is anyones guess but Janssen should at least own up to it and Geron should provide an explanation. I feel for any patient who saw this only to have their hopes dashed. bp

cheng_ho
Posts: 202
Joined: Sun Apr 03, 2016 11:27 pm

Re: compassionate use program?

Post by cheng_ho » Mon Nov 26, 2018 7:27 pm

bp, JNJ did in fact say that the compassionate-use listing was a mistake. And they DID take it off the list BEFORE the discontinuation decision... to our eternal disgrace (and that of our ancestors and descendants), we all ignored that blatantly obvious sign.

biopearl123
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Joined: Fri Jul 20, 2018 5:13 pm

Re: compassionate use program?

Post by biopearl123 » Tue Nov 27, 2018 10:24 pm

Bill Cheng, I don't think it was a mistake but rather a mis calculation or a last minute mind change. I placed great weight on that "mistake" and felt it was further evidence of Janssen commitment to the drug. Now that was a mistake.bp

Zhears
Posts: 74
Joined: Mon Oct 08, 2018 12:19 pm

Re: compassionate use program?

Post by Zhears » Tue Dec 04, 2018 5:33 pm

I got this back this afternoon.

Thank you for your interest in Geron, your feedback is appreciated.

Compassionate Use, or what is now referred to as 'Right to Try' is not something that Geron is considering at this time. Once the IND transfers back to Geron, which is expected to coincide with the timing of first patient screening and enrollment for Phase 3 of IMerge, then we would weigh benefits vs. risks for participation in the program.

“Pre-approval access” is the term used within Janssen for any access to an investigational medicine prior to its approval under its Compassionate Use and Pre-Approval Program. Pre-approval access programs may be implemented once Janssen has enough information to believe the risks associated with a particular medicine are reasonable in light of the potential benefit for a particular patient group.

We have been informed by Janssen that the listing of imetelstat and CSF1R as investigational medicines available for pre-approval access was an administrative error. As a result, both drugs were removed from Janssen’s compassionate use pre-approval access website. Please refer to Janssen’s website for more information, https://www.janssen.com/compassionate-u ... val-access.

-Jacob Goldberger, CG Capital

biopearl123
Posts: 1665
Joined: Fri Jul 20, 2018 5:13 pm

Re: compassionate use program?

Post by biopearl123 » Tue Dec 04, 2018 6:03 pm

This was some "administrative error" !!, and speaking for myself led me to buy more as it appeared as a clear endorsement of Janssens commitment. I do not buy this as a "mistake". While not a conspiracy theorist and I discourage such from this board, I do think there were several misleading events including job postings. If these were "mistakes", it seems unlikely. Its pretty clear they were deliberate. I don't think a company such as Janssen should hide behind this kind of excuse. bp

bucbeard
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Joined: Wed Jul 25, 2018 12:30 am

Re: compassionate use program?

Post by bucbeard » Tue Dec 04, 2018 8:55 pm

even if a mistake, aren't they now open to a broad investor lawsuit?

biopearl123
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Joined: Fri Jul 20, 2018 5:13 pm

Re: compassionate use program?

Post by biopearl123 » Tue Dec 04, 2018 10:01 pm

They should be for this irresponsible behavior but I doubt anyone could climb the Janssen wall of lawyers who would just plead innocent error.

karagozoglu12345
Posts: 61
Joined: Wed Oct 03, 2018 12:48 am

Re: compassionate use program?

Post by karagozoglu12345 » Thu Dec 13, 2018 10:41 pm

Folks tend to place the blame on J&J for inclusion of Imet in the compassionate use list, which had grossly misled investors. Apparently, Janssen had responded ,after the fact inquires about this, as “administrative error”. How could such “administrative error” can be simultaneously repeated to include Imet also in job posting which cemented investors’ belief that Janssen will file for NDA without phase 3. Who are the people responsible for this “error”? While compassionate use list is most likely handled by the clinical investigators, job posting tasks are typically performed by HR. How is it possible that two entirely different subunits in Janssen make the same “error” simultaneously? Only logical explanation is that clinical investigators asked HR to include Imet in the job posting. If that is so, how could this be an “error”?

But, more importantly, there is Geron side of this equation. I believe there was a joint steering committee in place, comprised of Geron and Janssen people. How is it possible that no one from the Geron side of this committee failed to notice Imet was included in the compassionate use list (seemingly a huge “progress” regarding intention to file with FDA without Phase 3)? For that matter, how could anyone from Geron management team failed to notice this salient occurrence and inquire about it and take action to get it deleted if it was in fact an error? Ironically, during the same time frame investors had widely noticed it and cheered such a pivotal “progress” and most likely added to their shares of Geron stock. Obviously, Geron people were not awake to notice it, if they were awake Imet would not have stayed on the compassionate use list for couple of weeks and this event would not have mislead investors. Parenthetically, Imet was deleted from the compassionate use list few days prior to negative CD. It is curious that someone noticed the error just in time!

Janssen is a large division of J&J with a portfolio of clinical trials. Their attention span spreads across a wide range of trials in that there may be a likelihood of error occurrence every now and then. What is the excuse from the Geron side? Geron is a one trick pony with responsibility for developing one drug only! If they were not on top of things for the Imet trials and its progress at least through the joint steering committee, what else were they doing to justify their hefty compensation?

Has Geron management been “awake” after the negative CD. I think not!

karagozoglu12345
Posts: 61
Joined: Wed Oct 03, 2018 12:48 am

Re: compassionate use program?

Post by karagozoglu12345 » Fri Dec 14, 2018 1:32 am

If inclusion of Imet was not an error and Janssen had intended to file, I still blame Geron management. They failed to clarify since then why was the data adequate for janssen to file at that time but not good enough for Geron management to file now but to extend the study for another year. They are yet to clarify why 30 months MOS is not good enough and what their target MOS is. CEO HAS DONE NOTHING TO RESTORE INVESTOR CONFIDENCE AFTER J&J BAILED. IN FACT, HIS ACTIONS TOTALLY BACKFIRED SO FAR AS EVIDENCED BY THE CURRENT SHARE PRICE DESPITE GOOD DATA. GERON NEEDS A SERIOUS SHAKE UP!
I apologize again to divert topic from science but I believe we the investors need to be proactive. If my facts do not add up, I graciously stand to be corrected.

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