Search found 1665 matches

by biopearl123
Thu Mar 28, 2024 1:14 am
Forum: ImetelChat
Topic: 12-2, take the win right?
Replies: 5
Views: 1410

Re: 12-2, take the win right?

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...
by biopearl123
Mon Mar 25, 2024 5:14 pm
Forum: ImetelChat
Topic: Down the road, way down the road
Replies: 5
Views: 1174

Down the road, way down the road

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...
by biopearl123
Fri Mar 22, 2024 3:52 pm
Forum: ImetelChat
Topic: Sergei Left a comment on LinkedIn
Replies: 2
Views: 1122

Sergei Left a comment on LinkedIn

Sergei seems happy that his creation has found deserved recognition. Wish he would come back home to Geron and bring MAIA with him.
by biopearl123
Fri Mar 22, 2024 3:03 pm
Forum: ImetelChat
Topic: Patients #3 and #9 had both been on Luspatercept.
Replies: 4
Views: 973

Re: Patients #3 and #9 had both been on Luspatercept.

CKTC, the expanded access protocol might provide data in Luspatercept failures. Might form the basis for a presentation at EHA.
by biopearl123
Thu Mar 21, 2024 11:34 pm
Forum: ImetelChat
Topic: Patients #3 and #9 had both been on Luspatercept.
Replies: 4
Views: 973

Re: Patients #3 and #9 had both been on Luspatercept.

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...
by biopearl123
Thu Mar 21, 2024 3:05 am
Forum: ImetelChat
Topic: Are they getting more positive results
Replies: 6
Views: 1110

Re: Are they getting more positive results

Good luck with that.
by biopearl123
Thu Mar 21, 2024 1:01 am
Forum: ImetelChat
Topic: Are they getting more positive results
Replies: 6
Views: 1110

Re: Are they getting more positive results

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...
by biopearl123
Wed Mar 20, 2024 10:51 pm
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 31
Views: 6854

Re: FDA v. Geron

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.
by biopearl123
Mon Mar 18, 2024 6:40 pm
Forum: ImetelChat
Topic: 12-2, take the win right?
Replies: 5
Views: 1410

12-2, take the win right?

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...
by biopearl123
Mon Mar 18, 2024 3:47 pm
Forum: ImetelChat
Topic: Mr. Chairman
Replies: 3
Views: 913

Re: Mr. Chairman

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?
by biopearl123
Mon Mar 18, 2024 4:30 am
Forum: ImetelChat
Topic: Mr. Chairman
Replies: 3
Views: 913

Re: Mr. Chairman

Of the 12-2vote, he almost said overwhelming but he stopped himself—but it was.
by biopearl123
Mon Mar 18, 2024 3:43 am
Forum: ImetelChat
Topic: Quite Surprising that....
Replies: 10
Views: 2699

Re: Quite Surprising that....

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.
by biopearl123
Mon Mar 18, 2024 1:53 am
Forum: ImetelChat
Topic: Mr. Chairman
Replies: 3
Views: 913

Mr. Chairman

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...
by biopearl123
Mon Mar 18, 2024 1:23 am
Forum: ImetelChat
Topic: CR’s/PR’s and CI
Replies: 0
Views: 381

CR’s/PR’s and CI

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 ...
by biopearl123
Mon Mar 18, 2024 1:13 am
Forum: ImetelChat
Topic: “Next Generation TI Program“
Replies: 2
Views: 792

Re: “Next Generation TI Program“

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.
by biopearl123
Sat Mar 16, 2024 6:27 pm
Forum: ImetelChat
Topic: Public Hearing Comments (Patient #3; Patient #9)
Replies: 4
Views: 816

Re: Public Hearing Comments (Patient #3; Patient #9)

HI, thanks for posting this link. I am planning to spend a lot of tomorrow reviewing the parts I missed. bp
by biopearl123
Sat Mar 16, 2024 3:05 pm
Forum: ImetelChat
Topic: 4 years of TI
Replies: 1
Views: 593

Re: 4 years of TI

I wonder if the two FDA “no” votes realize what a miracle that is.
by biopearl123
Sat Mar 16, 2024 6:46 am
Forum: ImetelChat
Topic: The fight to white out the black box
Replies: 0
Views: 544

The fight to white out the black box

CKTC’s theory about why the FDA came out with guns blazing is interesting. With all of the handcuffs placed on docs these days (read “you need prior authorization for that”) the fight to let doctors be doctors is valid and valuable. We hate being directed by others who have never even seen a patient...
by biopearl123
Fri Mar 15, 2024 11:43 pm
Forum: ImetelChat
Topic: Quite Surprising that....
Replies: 10
Views: 2699

Re: Quite Surprising that....

Great point, the FDA sets a statistical bar, it is met, but once it is, it’s still not enough? Thank G-d statisticians don’t treat patients. I am still stuck on the brew ha ha over the absence of CR’s and PR’s. Maybe someone can help me here. If LR patients have < 5% blasts, how does one assess a PR...
by biopearl123
Fri Mar 15, 2024 3:28 pm
Forum: ImetelChat
Topic: I raise my glass
Replies: 2
Views: 1007

I raise my glass

I raise my glass to Fish Sr.and Irish. Wish they could be here to help us celebrate. And of course to John and his team who had the vision to see this through to this point. And to all who have contributed to making this board worthwhile. My thanks and admiration. bp