From the first we heard of the hold and how it occurred, those on this MB have talked at length about the obvious possibility that the FDA should allow the Phase 2 MF trials to go forward and probably the MDS and AML pilot trials too, because of the serious nature of those diseases and the unmet need. Although DR Scarlett did not speak eloquently about this, he made it crystal clear they see it as a "possibility" at GERN and they are working on it, including the part we have discussed where the show the ASH results to the FDA to try to tip the balance by showing some efficacy. The sooner they put that proposal forward the quicker they will get the trials underway. I think the timelines that were discussed concerned a full release of the hold after data is collected and submitted; but that a partial release of the hold can occur and should occur much sooner. Dr. Scarlett told us that he will get access to the Tefferi data after it is submitted to the FDA and I believe that data will be critical to assist in getting a partial release of the hold. Dr. Scarlett sounded under a lot of pressure but he continued to speak highly of Imetelstat and there was every indication that he thinks the hold will be resolved and their trials will go forward. He is considering a European plan, but I think he has the partial release of the hold ahead of that plan. That is, I think they will seek a partial release of the hold to do the Phase 2 trials pretty soon, and if that is denied, they they will look at the European alternative. While there are not moving as fast as we have hoped, there is movement and data collection underway, and when they have their case, they will submit the data. I really don't see the issue being whether the hold will be lifted; but rather, the true issue that is make or break for GERN is efficacy of the data still being held by MC and the data they will collect in their Phase 2.
Geron's backdoor, as was discussed at the end of the conference call and several times previously on this board, is Mayo independantly submitting their response to the FDA and having the partial hold modified or removed. This event would in turn allow Geron to continue exploring Imetelstat with Myelofibrosis - although not additional indications until the general hold is addressed.
Bottom line: with eyes on the Mayo partial hold, as before, it isn't a question of if. It's when.
As for the liver enzymes, as was addressed during the conference, the data will show whether there is a toxic effect, a reversible effect, no effect, or improvement from baseline elevation. Regardless, it won't stop further testing down the road because the alternative to therapy is much worse.
What about Chemo Therapy's side effects of the devastating loss of people's hair and you can't eat and are extremely weak and then after doing that over and over the cancer spreads to your liver and kills you (happened to my paternal aunt and my maternal grandmother).
not good...going to Europe where patient enrollment is going to be much more slower than what is happening in the US now.
I hope Geron doesn't go out like this.....a slow death. Glad I sold the majority of my shares before the hold...thank god..
What happened to you and some others on this board talking about the hold being lifted in what 2 to 3 months? I was hoping that the FDA will come out soon to let the Geron-sponsored MF trial begin. It is frustrating to learn now that the hold may be at least a few months and as much as 9 months!! What happened to the damage-benefit issue? Scarlett didn't bring that up!! I doubt if a partial hold will be enough to begin Geron sponsored MF trial.
I don't necessarily agree. Scarlett does not have command of this. They have no timeline. They aren't even working with the FDA on collaborative terms. From all the information we have that is public and not on this board, the drug is effective, however, the timing of getting it to market has become more uncertain. Investors don't like uncertainty. And they are going to gather everything they can, submit it, and wait for the FDA to respond to let them know if they need to submit more information? Terrible progress to this point in my opinion.
They have ONE CHANCE to get it all together. Why would they be hasty and submit something less than the required--though nobody knows what the FDA requires, per se, except for the FDA? The burn $40M per year and they have $153M in the bank. Almost 4 years' worth.
End, isn't it disgusting that the bozos haven't done much in the period of two LONG months since the hold was placed? They have nothing else going and, hence, could have worked day and night to submit the data FDA needs; but, alas, they don't appear to have their act together yet and still talk in terms of probabilities!! The question is, as Blackmarango has been asking, whether Scarlett deserves the 2.3M compensation he receives from this cash-strapped company? Isn't that highly unethical on his part to squeeze that much money for doing practically nothing? And what is Huh doing? he squeezed a million dollars!! What would have happened to this company had Tefferi and Mayo did not do what they did? This company is surviving on the glory brought about by Mayo, and not by any of the Geron bozos, isn't it? Note that Imetelstat was developed by scientists working at Geron long before these bozos took over, it's NOT their baby!!
"I think they will seek a partial release of the hold to do the Phase 2 trials pretty soon, and if that is denied, they they will look at the European alternative."
Since European trials were intended eventually they should get the wheels turning on them ASAP rather than waiting on the FDA decision. We need to see movement in the program. Sitting on our hands is killing the share price right now.
RX, I think Dr Scarlett made it clear that they have the European cites lined up and ready for the Phase 2 if the partial release is obtained. I also understood him to say that his current thinking is that it is not clear they want to pursue the European option. I believe he was saying they hope to get the partial release of the hold and get back on plan, but the European plan, as he visualizes it, would not necessarily use the cites that are ready for the phase 2 trials already lined up in Europe. Instead, one of the issues with the European plan is lining up some alternative cites to conduct an alternative plan, not yet worked out with the cites or the European authorities. I think they are going slow on this for now, but at least they are addressing it rather than being silent. As to the share price, the release of the hold still is a very good bet, and now the price ratcheted down for another opportunity to buy cheap shares.