ImetelChat

Question:

Is the MF trial and the MDS trial still joined? Will the start of a Phase 3 MDS trial experience continued delay until Janssen receives whatever answer it’s looking for w/ regard to the MF trial?

And if the MDS trial results are as good as they appear to date why does a Phase 3 MDS trial depend on the results of the MF trial, if that continues to be the case?

Based on what JS has said about that (also in 8K/10Q) the answer is yes. But I am not sure what to think about this somewhat strange inter dependency. If I ignore what JS said, I would think that JnJ could take a positive continuation decision if MDS goes well as it seems to do. The JnJ website says IMerge is in P3 (?) and almost all of the 82 sites are recruiting. Patients can directly submit their registration to participate through the JnJ website. But JS clearly suggested that IMegre continuation depends from IMbark, and the continuation decision depends from IMbark. Yet, purely from a business perspective I would say JnJ has various options, depending on their proposed strategy on imetelstat and TI in general. If JnJ doesn't continue the CA, there are still various possibilities.
- they can take a license just for MDS, so they can finalize IMerge and get approval for that single indication.
- they can license imetelstat for MPN's
- they can license imetelstat for hem-oncs in general
- they can quit TI as a whole and drop imetelstat from their pipeline

It is difficult to imagine that JnJ will walk away completely if they drop IMbark, given the fact that imetelstat seems to outclass BAT in MDS (especially in this large subgroup). However, even if they continue the CA I don't rule out changes to the agreement. They can keep the license as is, leaving Geron as an independent company or do a buy-out at a certain moment in time. The options above also count in case they proceed with the collaboration agreement (apart form the last one....).

So this all depends from 1) how successful imetelstat is in current trials and 2) the strategic importance of imetelstat/TI for JnJ's business.

Fish,

Thanks for your response. The issue appears complicated. I hope we obtain some clarity w/ regard to this issue. The sooner the better.