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Time Line

Posted: Sat Feb 20, 2016 7:44 am
by idomerfeld
Hello, i am new on this board, i was looking for a more tuned down and educative forum to discuss Imet and Geron (other than yahoo),
if Irish is hear, maybe i am in the right place.

can I offer to have a discussion on the expected time line of Imetelstat approval in all future indications, including major milestones and upcoming important events, if this discussion will result a quality and detailed time line with probabilities attached, the site manager can publish it as a formal section in the website, updated from time to time

Re: Time Line

Posted: Sun Feb 21, 2016 11:14 am
by Fishermangents
Hi idomer, welcome here! Good suggestion: any form serious discussion is highly appreciated. Speculating about timelines is especially interesting, because for that we need to try to see the unkowns based on what we do know. So let's start the discussion and see how much we can get to the table!

The timeline can include milestones of various nature, like clinical, commercial, biological, regulatory etc. So why not start first to set up a list of potential milestones and then see if we can put some dates to it? If this discussion will get lively enough we can always turn it into a separate sub-forum.

Thanks for your initiative!

Re: Time Line

Posted: Sun Feb 21, 2016 11:18 am
by Fishermangents
btw: irish is here, as well as known experts such as Phil, Greg BioPearl and Hoosier. Good ingredients to start a good discussion, I would say....

Re: Time Line

Posted: Mon Feb 22, 2016 3:59 pm
by Fishermangents
Maybe a first atempt to set up a timeline based on events/milestones:

Clinical:
Imbark & Imerge: early readouts
CT1951: Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure); Can we expect other milestones from this study?
AML: start clinical combi-trial (2nd part 2016?)

Regulatory:
Fast Track
Breakthrough Therapy
Accelarated Approval
Priority review
NDA submission

Commercial:
JnJ Continuation Decission (2nd part 2016)
Geron opt-in decission (2nd part 2016?)