As Mayo explained: Imetelstat is personalized medicine.
Imetelstat requires dynamic administration based on a range of individualized variables, partially define by Mayo that must be further refined to an algorithm.
Geron nor its cadre of pre-package CRO's is capable of orchestrating Imetelstat into a trial. Imetelstat needs to be further refined with a big pharma partner and trials conducted only at premier medical centers focused on its personalized administration requirements.
Because this is not clear cut, in bite size pieces for the market to swallow, we are in a tailspin.
What about the other 12 Clinical trials that GERN has already run, most of which were with Imetelstat. They have already been through the drill several times without problems with over 100 locations. What makes you think they cannot do it again?
E2W, it is my opinion, and I have experienced this as an investor, that it is easy for management to accept a low CRO bid. But, in the case of imetelstat, and I think the Mayo trial illustrates this point, that without exceptional myelofibrosis experience, treatment management could be easily botched.
If not properly monitored and managed, unacceptable side effects could shut down a trial, or fail to maximize potential efficacy. We are starting to see personalized aspects of imetelstat emerge, not in terms of genetics yet, but very dynamic dosage programs.
Geron can increase the robustness of a trial by increasing the number of patients enrolled, but by themselves, they are certainly limited in terms of the size of a phase 2. Second, the Mayo trial enrollment criteria was loose, so Geron could tighten this up to select for those patients most likely to demonstrate a response.
The temptation is to farm out to international CRO's, some of which are good, while others are not. At this time, and this is just my opinion, but because cancer trials are so expensive, and Geron does not have a history of being in oncology and has managed to accumulate a series of failed trials in oncology such as breast and lung cancer, they should understand that a partner with significant oncology experience is needed.
I have no doubt that they can run a trial. My concern is they are underestimating oncology and that this phase 2 could be easily approached in the wrong way in terms of choosing a protocol, choosing the medical center involved, and having the liberty to increase the size to where it needs to be to ensure that all of the efficacy that can be found is indeed found, without any unnecessary side effects.