An interesting post by BP

[sargasso]

BP,

I like the way you think, bp. I like the inferences you are drawing. I like the way you are reading the tells. Of course no one knows at this point how all of this will play out but I find your ideas as plausible as any other alternative scenario. I’m referring to this excellent post:

Hello rajorgensen, I have read your comments with interest. I hope you will allow me the courtesy of making a few counterpoints. There are three general areas I wish to address. 1. The company, 2. The drug 3. The disease. The company: Geron is making a dash for the finish line that began with jettisoning its core raison d'être: stem cells and keeping the most reasonable course to commercialization. That had to hurt and certainly disappointed those of us who hoped for Geron driven stem cell therapies --naturally the heritors carry on the work however. 2. Imetelstat is a unique molecule that has properties not seen with other drugs namely, in a partially specific way, targeting the malignant clone in certain hematologic diseases and reversing bone marrow fibrosis--something unique. 3. MF and MDS are incurable short of bone marrow transplant. I suspect you have never felt a painful and massive spleen or seen a fibrotic bone marrow under the 'scope or given a desperate patient chemo. These experiences may color and indeed deeply affect a person who has, and perhaps add the dreaded personal experience to contrast your cool analysis of a business opportunity. I submit that the FDA wants to bring therapy forward for severe (in this case uniformly fatal) diseases that are heretofore unmet. There are plenty of hints that there is communication ongoing with Janssen/Geron and the agency. The absence of a planned phase III in the MF trial is one. The trial is ongoing and there are indications that the mother of all ends points is being pursued: OS. If shown conclusively in phase II a trip to a phase IV study is possible, hence no plans for a phase III. I know you doubt this but I refer you to the Brookings Institute study of this potential in unique (which we have) circumstance. Re MDS, Geron/Janseen could have presented the results of the first 30 patients last year at ASH, they had the data. Why wait you might ask (and why haven't you?) The answer I believe lies in proving durability to apply for something with the agency, I don't know what but fast track, accelerated approval, BAT--something must have driven this trial design. Knowing that some MDS patient require 30 (!) or so blood transfusions a year must have the agency's attention. You truly have no way to know whether an NDA is in progress and being built on with rolling serial ongoing submissions. The company is under no obligation to tell us and I would prefer if they don't. If you want to apply cool clinical rational analysis to this particularly unusual and unique situation please do and I will read your reply with interest. And Cheng why don't you weigh in, I know you will. 2018 is upon us soon and a post ASH completed filing is also, at least for MF. Regards, bp
09 Jul 2017

https://seekingalpha.com/article/408582 ... t-75632439