EMA Prime

[jpheis]

Reflecting and contemplating. JS stated two things that have me pondering Imetelstat might be going for EMA Prime in MF. ‘we haven’t reached the median OS yet. How that will play out regulatorily will demand really some careful thought around the world and also probably some level of interaction with experts.’ And ‘We wouldn’t want to be getting out ahead of some of those discussions and we still kind of need to reach meeting OS, in order to really know where we are.’

As pointed out by others, JS took care not to state ‘median OS’ and he took care to state ‘around the world’ At least I’m my business world, alluding to careful thought and interactions with experts means those interactions are already underway. We’ve been focusing on FDA BTD. Perhaps we should look across the pond first.

[Fishermangents]

If Median OS is not reached, that is good. In order to put the survivors into the perspective it is important how these survivors are doing, why they survive, even after Median OS has been achieved. That will give additional weight to the benefits and to see the depth of PR's and CR's and the targeting of the malignant clone. Therefore they will assess all data available globally from those still alive. In that sense this 4.7 low dose arm might be more relevant than we (and JnJ/Geron) may have anticipated.

[biopearl]

Fish, agree completely. Jpheis, I interpreted JS comments a little differently (not to say I wouldn't love to see early EU approval first) but his comments about how MDS is treated in Europe suggested that they were targeting Europe for front line MDS therapy. I did not get a sense that he was suggesting anything different about MF in Europe. No doubt that (especially given the worldwide footprint of Janssen) that they are in parallel discussions with the EMA as with the FDA. The race is on! Best wishes, bp

[jpheis]

BP- i am priveledged to have the smart minds of this board to set me straight and sincerely appreciate the response from you and Fish. I should clarify that the JS statements I quoted were in response to Stifel’s Alex Schwartz question regarding the need for a P3 in MF. As I see it, JS was only talking about MF in his response. I’m going off the SA Monday earnings call transcripts. To your point elsewhere on this board, ethically the FDA would be duty bound to not pursue P3 with a control. I hope Sdraw can add input. I’m struggling to see where GERN and J&J deviate from PRIME and BTD in MF - in short order.

[Dogonenuts]

In regards to the original post, my impression that primary designation was definitely open in Europe for MDS, not MF necessarily, though one could see Jak inhibitors already on a slippery slope worlwide, but that is just my conjecture.