Re post from SA

[biopearl123]

Del, when you write your article (and I will look forward to it), if Janssen shifted toward CAR-T which seems likely, one would think a window for Imetelstat still is very open. As you know, CAR-T is patient specific and at least currently, involves harvesting a patients own cells making it a very expensive process >.5 mil/pt. Also a single cell mutation can cause recurrence as noted in a very interesting case study discussed here and on Imetelchat recently. The focus in CAR-T seems to be in MM and AML leaving the MDS market to more conventional therapies for now. Also an emphasis on younger patients will be apparent because of costs. Imetelstat is an off the shelf med and honestly the data in both studies is pretty incredible. Even though, yes Jurassic park, what about combination with BCL-2. What if those results rival CAR-T? No clinical combo studies yet and that will take a long time to play out. What is apparent is that as a single agent, Imetelstat has surpassed luspatercept, HMA's and may present a very attractive alternative to bone marrow transplant. We are all futurists on this board. Yes future therapies may leap frog Imetelstat and probably will. But not for a while and especially not until combination therapies are explored and perfected (well, I say perfected advisedly). Now its a matter of regulatory recognition that Imetelstat is BAT in both indications and should be approved or at least provisionally approved. Our speculation about using the 4.7 group as a "control" remains a strong argument in the MF group. It is crazy to wait 9 months for a 'plan". Hope to see your thoughts and something equally enlightening from MTB soon. Points worthy of emphasis include durability of TI, stability or improvement in bone marrow picture (50%! in MF study), , efficacy in awful genetic mutations (ASXL-1), reversion of heme picture to more mild disease (RS), extraordinary MOS with MOS in TN not reached (a nice surprise for me, I doubted that would happen) taking LE to 5 times the expected in this small subgroup, The FDA wants surrogates for OS, they have it in multiple departments including molecular markers. Janssen wants to pursue other alternatives treatments that may be better (we shall see), fine, they have a long time line. In the interim Celgene as lost some market share and certainly Incyte must feel the heat since their whole MF market could be in jeopardy since once approved in R/R, there may be a push to use off label, maybe that's why Scarlett has withheld the pilot data in about 40 patients we know nothing about (AND SHOULD). One door closes, another opens. Best wishes to all, bp