ImetelChat

I am with Cheng on this one. This all ages and all indications sounds pretty encompassing but it appears to refer only to all pediatric ages where the drug clearly as yet has virtually no niche. Annie has been tracking this for a while. There is little doubt that Janssen has done and been doing all ...

Fish, this is also my recollection. Re origin of announcement, maybe go back to original Janssen collaboration announcement or presentation that followed ASH when Dr. Lane presented his study. It was definitely mentioned in follow up calls but then notably absent during last quarter update. Sdraw's ...

Cheng, I believe snippets from previous patient conferences have been posted, don't know if they were sponsor driven or videos taken by patients and then posted. 100 patients can sign up, suspect some may wish to share the content of the meeting especially with Dr. T's presence. If anyone knows some...

Scarlett once said he wasn't trying to be coy. Well he is. Coy, opaque, vague, and infuriating. Its one thing to hold information for competitive reasons but this! I am referring to the deliberate withholding of data from the pilot study. Or is it withheld? If one looks on the CT site the pilot stud...

Hunt, agree with Fish, doubt we will see any solid tumor studies for a while, J and J has their hands full with hematologic diseases. I think it is safe to conclude that clinical solid tumor studies to date have been abject failures. Heck I don't even know if they still plan for the AML study based ...

Thanks Cheng, nice article. Some of table 2 studies indicate "results not available in public domaine". I interpret this to mean no positive effect. I think a positive study would require release of information to stockholders as a material event and its just not there for the studies noted with the...

Hi Fish, sorry I had to post and run, had a lot of work. Have been thinking about this study a bit. It is really very similar in content to the earlier study citing the need to stop enrollment and the findings of enrollment limiting toxicity. At least we know that Imetelstat gets into the tumor (2 p...

Reference:Cite this article as:
Salloum, R., Hummel, T.R., Kumar, S.S. et al. J Neurooncol (2016). doi:10.1007/s11060-016-2189-7

From the Pediatric Consortium study June 27 2016 published online (will try to post link, if not maybe Fish can help) <<Of two evaluable patients on the MB trial, intratumoral telomerase activity was inhibited by 95 % compared to baseline archival tissue in one patient and was inevaluable in one pat...

Fish, thanks for clarifying all of this, it is very helpful to me. Regards, bp

Fish, thanks for your great work on this. Can you help me clarify one thing? Under Article 4 it says <<A conditional marketing authorisation may be granted where the Committee...>> Which committee does this refer to? COMP or CHMP? or other? What I am trying to get at is since we know ODD was granted...

Fish, kudos for assembling and analyzing this info in such a cogent fashion. CMA was developed so drugs like Imetelstat would not languish. Janssen is too savvy to not be tuned to the most efficient path to approval. We have a window into to evolving approval process via the EU/COMP/CHMP agendas and...

The CHMP website shows a timeline of 277 days from submission to approval for most EMA meds. The ODD may have a faster timeline but I am not sure. We know the application had to precede November by some time when ODD was considered (or I don't know if the clock starts when ODD is granted), anyway we...

Fish, right. Then why the second visit to the committee six months later, if not to confirm drug response as required by the committee? Assuming it was confirmed then can we imply market authorization is imminent? (I am trying not to jump the gun here but I keep coming back to the same conclusion th...

We know orphan drug status was conferred in Dec. But there is a difference between orphan drug stats and orphan drug approval. Thanks to Annie we know the committee for orphan drugs (COMP) met as recently as last week but we don't know what happened. The agenda is available for review and I think th...

Hip, thanks for posting the article. This article is from 2014 and definitely worth adding to Fish's compendium. I do think devoting our collective time in trying to discern whether EU approval is close is worthwhile. Wish Annie hi links and some knowledge of EU protocols were available to us. bp

Hi Fish, Annie has posted some very interesting and I think very pertinent material. I hope she will participate in this board, YMB is now the new tower of Babble. My question is that we know that the orphan drug designation was granted some time ago by the EU committee, does this same committee aft...

Fish, I am speculating here but, re CNS tumors the only clinical supporting data that could be presented to EU (besides in vitro cell studies) would be from the as yet unreleased Pediatric Consortium study I would guess, so I haven't seen the report but someone mentioned heavily redacted areas that ...

If one adopts an orphan, he or she becomes a member of your family. bp

This is the essence of my deleted post. I am sorry the other one was lost but it might have been too full of musing on a hot summer night anyway. I was thinking about the MDS study clearly not being in phase III despite the rather misleading presentation on CT site and other listings as so as well. ...