Search found 348 matches

by Ryan
Wed Jan 24, 2024 8:42 pm
Forum: ImetelChat
Topic: FDA Boxed Warning for CAR-T
Replies: 2
Views: 1345

Re: FDA Boxed Warning for CAR-T

6 Papers from Dana-Farber Cancer Institute retracted. Altered images fooled peer reviewers, just shocking. Correction: I can’t confirm that these retracted papers were CAR-T Seems as if fabricating medical research has become an epidemic: https://www.science.org/content/article/whistleblowers-flagge...
by Ryan
Sat Jan 20, 2024 2:46 am
Forum: ImetelChat
Topic: ADCOM
Replies: 96
Views: 292179

Re: ADCOM

Definitely some interesting points here.

It’s only a matter of time at this point… 5 months maximum at this point. Unbearable but still a finite amount that we can count on one hand.
by Ryan
Mon Jan 15, 2024 11:53 pm
Forum: ImetelChat
Topic: A new Irish Trader? Hat tip to Paul C
Replies: 17
Views: 6375

Re: A new Irish Trader? Hat tip to Paul C

There is little doubt that this is a true testimonial from a real patient… given the details supplied about treatments before Imetelstat in particular. And I wouldn’t see this as surprising either, the data we have all seen has shown this type of improvement. It is great to see a real story and live...
by Ryan
Tue Jan 09, 2024 5:15 pm
Forum: ImetelChat
Topic: ICER - Institute for Clinical and Economic Review
Replies: 5
Views: 1212

Re: ICER - Institute for Clinical and Economic Review

I wonder if the FDA pays attention to the ICER findings. I wouldn’t know but I wouldn’t think so. I believe such an independent panel could influence Insurance companies and regulators for the points BP referenced. It is interesting that there is an open call for input into late January. I’d be int...
by Ryan
Tue Jan 09, 2024 3:09 pm
Forum: ImetelChat
Topic: ICER - Institute for Clinical and Economic Review
Replies: 5
Views: 1212

Re: ICER - Institute for Clinical and Economic Review

From their website: “ICER provides an independent source of evidence review—free from financial conflicts of interest—to address these fundamental questions. By doing so, we help patients today and in the future by catalyzing a movement toward fair pricing, fair access, and future innovation across ...
by Ryan
Tue Jan 09, 2024 6:38 am
Forum: ImetelChat
Topic: ICER - Institute for Clinical and Economic Review
Replies: 5
Views: 1212

ICER - Institute for Clinical and Economic Review

ICER to Evaluate Geron’s Imetelsta for the Treatment of MDS https://www.navlindaily.com/article/20031/icer-to-evaluate-geron-s-imetelsta-for-the-treatment-of-mds Imetelstat for Anemia in Myelodysplastic Syndrome Draft Background and Scope January 3, 2024 https://icer.org/wp-content/uploads/2024/01/M...
by Ryan
Sun Jan 07, 2024 8:27 pm
Forum: ImetelChat
Topic: Off-Topic - GERN stock
Replies: 4
Views: 1517

Re: Off-Topic - GERN stock

Geron has recently added a Sr. Director/Legal Counsel who started her career with the FDA. Perhaps this helps with the MA lock? -Kmall Nice piece of info and I align with the call. However, I have little doubt that while we wait for marketing authorization, and perhaps even as Revenue begins, our ‘...
by Ryan
Fri Jan 05, 2024 11:50 pm
Forum: ImetelChat
Topic: Off-Topic - GERN stock
Replies: 4
Views: 1517

Off-Topic - GERN stock

For Imetelstat, I think we are in a great place. 5 month countdown is on (if that) and the chance of marketing authorization does seem a lock. The data though.

For GERN stock, given Week #1, expect max pain this year, IMO.
by Ryan
Fri Dec 29, 2023 6:34 pm
Forum: ImetelChat
Topic: A few thoughts for the end of the old year and the beginning of the new
Replies: 5
Views: 2161

Re: A few thoughts for the end of the old year and the beginning of the new

All good thoughts. My guess is the vast majority of individuals on this board are gassed, but the announcements in Q1 and definitely Q2 should catalyze a reinvigorated group. I still think the standard review, really the only “bad” news of the year for the drug, is to review what is a new class of d...
by Ryan
Fri Dec 22, 2023 4:16 am
Forum: ImetelChat
Topic: ASCO Post
Replies: 0
Views: 1115

ASCO Post

by Ryan
Thu Dec 21, 2023 10:58 pm
Forum: ImetelChat
Topic: 2023 - What a Long, Strange Trip it’s Been
Replies: 3
Views: 2759

Re: 2023 - What a Long, Strange Trip it’s Been

And no announcement for Imet 2.0 ( I would suspect that is coming in the first half of January)…

But of course one more round of Inducement Grants to end up the year! Can’t believe I didn’t reference Inducements as another main theme for the year.

Build that team, I’m not mad at ya.
by Ryan
Wed Dec 20, 2023 6:28 pm
Forum: ImetelChat
Topic: 2023 - What a Long, Strange Trip it’s Been
Replies: 3
Views: 2759

2023 - What a Long, Strange Trip it’s Been

As I look at the stock price, and realize that for the year the pps is going to be just about where it was on December 31, 2022, I realize what a crazy year it’s been for Geron. (Hence the Grateful Dead lyric.) Remember that it was in the first week of January that the MDS Phase III initial results ...
by Ryan
Fri Dec 15, 2023 8:58 pm
Forum: ImetelChat
Topic: About two weeks
Replies: 4
Views: 9223

Re: About two weeks

Another video, posted on Yahoo! this morning:

https://m.youtube.com/watch?si=EYbTtt-Q ... e=youtu.be
by Ryan
Tue Dec 12, 2023 5:48 am
Forum: ImetelChat
Topic: Geron Announces IMerge Phase 3 Presentations at ASH Highlighting Significant Durability of Transfusion Independence and
Replies: 1
Views: 2665

Geron Announces IMerge Phase 3 Presentations at ASH Highlighting Significant Durability of Transfusion Independence and

https://ir.geron.com/investors/press-releases/press-release-details/2023/Geron-Announces-IMerge-Phase-3-Presentations-at-ASH-Highlighting-Significant-Durability-of-Transfusion-Independence-and-Breadth-of-Effect-Across-MDS-Subgroups-with-Imetelstat-in-Lower-Risk-MDS/default.aspx “As we continue to se...
by Ryan
Tue Dec 12, 2023 2:34 am
Forum: ImetelChat
Topic: Adverse effects
Replies: 8
Views: 11323

Re: Adverse effects

Plenary session during the ASH conference. Has no relevance to FDA decision on marketing authorization.
by Ryan
Mon Dec 11, 2023 9:04 pm
Forum: ImetelChat
Topic: Adverse effects
Replies: 8
Views: 11323

Re: Adverse effects

True. Bluebird’s box warning was related to the risk of emergence of rare cancers. Fortunately, the grade 3 and 4 events with Imetelstat were not and appear to be reversible. Again agree. “Adverse effects” are in different leagues, however Geron seemingly will need to put in effort to avoid any war...
by Ryan
Mon Dec 11, 2023 5:05 pm
Forum: ImetelChat
Topic: Adverse effects
Replies: 8
Views: 11323

Re: Adverse effects

True, good point.
Tangentially, Bluebird treatment got slapped with a box Warning. To state the obvious, Not looked on positively.
by Ryan
Sun Dec 10, 2023 8:58 pm
Forum: ImetelChat
Topic: ASH - twitter
Replies: 10
Views: 12859

Re: ASH - twitter

Nice, extended follow-ups and breakout of subgroup (using IPSS, prognostic scoring system).

Let’s see if this Phase III extended data leads to a Plenary…
by Ryan
Thu Dec 07, 2023 7:31 pm
Forum: ImetelChat
Topic: An open inquiry..
Replies: 5
Views: 6929

Re: An open inquiry..

I think it’s sooner rather than later biotechs are going to implement AI to find potential optimizations to their drugs (molecules) as well as analyzing combinations , etc etc etc…. Probably another reason why the global giants have a huge advantage with their IP. I would gather that company announc...
by Ryan
Tue Dec 05, 2023 8:23 pm
Forum: ImetelChat
Topic: Dr. Patnaik, editorial comment in Lancet
Replies: 10
Views: 17688

Re: Dr. Patnaik, editorial comment in Lance

Like every major featured article in a top tier medical journal, a prominent physician is asked to comment. I did "buy" 24 hour access to the comments by Dr. Patnaik of the Mayo in Rochester. I am sure I had to agree not to reproduce it so I will just summarize a few points. Dr. Patnaik summarized ...