ImetelChat

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...

Pretty sure one of the docs (?Dr. Savona) said about 30% of the Lus patients couldn’t get past the first dose because of fatigue. Did anyone else hear that?

Of the 12-2vote, he almost said overwhelming but he stopped himself—but it was.

You can be sure that research will be directed here, especially with EHA and ASH coming. The problem of course is that if subgroups are identified, the market could narrow. More likely will be a search for an effective combination.

I thought Dr. Madan was fair and even handed in the way he ran the ODAC meeting, even charming. Interestingly, he readily admitted to not being a heme/onc doc but a solid tumor specialist and that he would rely heavily from the input from his heme onc colleagues. But seemingly he did not. In so stat...

I think the committee made it pretty clear to everyone (maybe except the FDA itself) that CR’s and PR’s have no relevance in the evaluation of agents in treating L/R MDS. Transfusion Independence or reduction is really the best yardstick for evaluation, as is symptom improvement, QOL and maybe life ...

Lekola, that program is very early and I suspect now Geron will slow roll it and keep the focus on approval for IV Imetelstat. Probably looking at a five year timeline (at least) for development and moving through all phases of required study.

HI, thanks for posting this link. I am planning to spend a lot of tomorrow reviewing the parts I missed. bp