I was ABSOLUTELY RIGHT when I was concerned that GERN did NOT have the requisite data to satisfy the FDA Hold!!!!!!!!!
" The timing for our submission to the FDA of a complete response to the full clinical hold on our IND for imetelstat depends on our ability to collect such clinical information from our Phase 2 ET and MM trials and the Myelofibrosis IST. If we are able to collect such clinical information in 2014, assuming the data are positive, and the FDA agrees that such information and data adequately address the basis for the clinical hold in order for the FDA to lift the full clinical hold on our IND for imetelstat in 2014 or permit us to study imetelstat under a partial clinical hold in 2014, we would plan to initiate a Geron-sponsored clinical trial of imetelstat in MF in the United States which could potentially occur as early as the first quarter of 2015"
Yeah, that was not encouraging at all. I just wonder what the protocol design was that they didn't have the necessary liver data that the FDA has requested. Like wouldn't you want to be collecting and saving liver toxicity information on these studies as a matter of course? I try to remain optimistic, but I'm really surprised they have to amend their study protocols to obtain this information and that it wasn't part of the original study design and data collection.