There are two things
Posted: Wed Nov 04, 2020 1:25 am
There are two things that will improve this stocks value. 1. A partnership 2. A buyout. There is nothing else really. As most of you know I have supported the Geron narrative for many years and I have been "guilty" of contributing to it. Lately, I confess to find it troubling to find my words from years ago coming's back in other peoples posts and I am starting to feel the weight of responsibility. Here's the deal. The timeline continues to stretch into infinity as we look toward 2022 for the earliest possible event (short of 1 and 2) that will improve value. (I have little doubt COVID will push this further out.) We hold a valuable stock. A stock that can improve the lives of patients with hematologic cancers. It won't be approved though for a least a couple of years and we need to take a hard look at the reality. IF the FDA had allowed Dr. T's study to go forward we would know if there was a role in front line therapy. They didn't and we lost 5 years (!!). IF Janssen had not jettisoned the drug, then part II of the MDS trial would be enrolled with perhaps early data. They didn't and we lost years of development time while the drug was transferred back to Geron and Geron had to deal with a clueless FDA (yes the ones who tried to add additional cost and time to the upcoming MF study by "suggesting" yet another treatment arm.). What about the EU? The silence is deafening. If hypothetically the EU were to grant some type of approval no one would enroll in the MF or MDS study since there are so many European sites and since they could just get drug without risking being assigned to a control arm. The FDA is requiring these studies for US approval hence the company can not even ask for EU approval now or else US approval becomes impossible. The data is good, the drug works, let me count the ways. The road blocks are immense. If you hope this stock will appreciate, and we all do, don't look to any near term approvals. Look to a partner and additional studies (what is that 75 M for please?) or a buy out (some far sighted smart BP please!) But don't look to approval. ASH is around the corner, durability and anticlonal effects will be manifest. It's really been sad yet illuminating to watch how difficult it has been to get this "game changer" drug through the approval process. I have always said to keep the faith (through dilution and disappointment), in the drug but keeping faith in the process has been a trial. The fits and starts (the AML study that was promised--twice I might add, the complimentary company acquisition that never happened.) Come on Man! (Just a little election night humor.) A Shanda. Here's hoping for an enlightened FDA on this election night. I will make one prediction, Dr. Scarlett will announce we are 50 % enrolled in the MDS study on Thursday. Best wishes to all. Discussion encouraged. bp