ImetelChat

Ok gents, this is drifting into the ad hominem. Don’t make me get out the red pencil.

I am in transit after an extensive visit to the Gaza/Israel boarder to evaluate the Magen David Adom (Israeli equivalent of the Red Cross). I would love to share my thoughts and experiences there but I can not without violating the basic guidelines we have for the most part kept to on this board. I ...

Submitted on the fly from Tel Aviv: 1. In patients with long term TIs can we start thinking about potential cure or is there still evidence for minimal residual disease? 2. Does the DMB have the power to recommend early discontinuation of the either MF study for efficacy? 3. Have any abstracts been ...

I have not had time to listen directly to the quarterly report today but gleaned that there was an extension of the timeline for “first look” data into 2026 due to patients living longer. The DSMB reviewed data and allowed the study to continue. As we know this means no futility signal and no undue ...

Thanks Fellow Board members and those who have communicated privately with me. Heading out early tomorrow. Back in about ten days. A few quick thoughts to be posted on the next thread.

Just a pat on the back and a thank you to all who have supported this board over the years. I suppose it’s not too optimistic to reopen the discussion of Turtle Island. For me, well, just too old now. Will have to sock away those gains for long term care :). For some however I truly hope you get the...

I like this one: “ Imminenter”. Probably should submit to Merriam-Webster for new word of the year.

Why is JS smiling that confident smile? It’s not because FDA approval for LR MDS is pending. He smiled that smile a long time ago but maybe some people just didn’t notice. Nope. He is smiling because he knows two prominent things (among the many). #1. The AML study was extended by a year a while bac...

The implications of disease modification are clear namely altering transformation to AML. Nice to se it entering mains discussion. Lots of anticipation here but not hard proof as yet. You can be sure they are looking. bp

Ravi, Ravi, Ravi, of course they do. HI is broken out into major (Complete TI) and minor (Partial TI) the latter is described as a 50% reduction in TR over 16 weeks (but not complete TI, still impressive). These two groups compose is a majority of patients in the study (about 70 total), of course th...

Readership up by a factor of ten, clearly lots of new found interest. We will see what happens over the next few months. I think there will be a lot of new stock buys in anticipation of approval and or acquisition, both of which are highly likely. Since first look at MF data possibly occurs in less ...

Hi Hunt, I think your letter is a great idea but I would say coming to the important conclusions that the FDA is tasked with making, is an evolutionary process. For example, if the ODAC were given the FDA position paper and then asked to vote before they heard Geron’s presentations, how do you think...

Interesting to follow MAIA who as LWS said seems to have caught a tail wind from the recent Geron FDA ADCOM results. The MAIA leadership has bought shares but has an interesting background: “ Dr. Smith is president of Smith Economics Group, Ltd. in Chicago, providing economic and financial consultin...

Sergei seems happy that his creation has found deserved recognition. Wish he would come back home to Geron and bring MAIA with him.

CKTC, the expanded access protocol might provide data in Luspatercept failures. Might form the basis for a presentation at EHA.

Great post HI, thank you. I was a little intrigued by the FDA’s assertion that implied that more patients benefited from Imetelstat who lived outside the US. The number of US patients being comparatively small and certainly not subject to much of a meaningful statistical analysis. Geron has basicall...

Good luck with that.

Whoa! It’s pretty unusual to hear about results in a study that is ongoing but this is a single arm study so it’s not like there is a placebo group. Very interesting find. Clinical trials.gov did change the expected top line report date and extended it by about a year. Certainly made me wonder if pa...

RC, also important here is where all the positive votes came from (every liquid tumor doctor), including an invited specialist. That should give us some reassurance that failure to approve is unlikely.

I suppose the smart thing is to take the win and move on toward approval, right? But I am troubled. There were still two strong voices who voted against, who will probably continue to be heard as approval moves forward and perhaps be voices in favor of the dreaded “black box” (ok maybe not so dreade...