Search found 348 matches
- 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...
- 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.
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.
- 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...
- 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...
- 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 ...
- 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...
- 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 ‘...
- 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.
For GERN stock, given Week #1, expect max pain this year, IMO.
- 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...
- Fri Dec 22, 2023 4:16 am
- Forum: ImetelChat
- Topic: ASCO Post
- Replies: 0
- Views: 1115
- 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.
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.
- 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 ...
- 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
https://m.youtube.com/watch?si=EYbTtt-Q ... e=youtu.be
- 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...
- 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.
- 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...
- 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.
Tangentially, Bluebird treatment got slapped with a box Warning. To state the obvious, Not looked on positively.
- 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…
Let’s see if this Phase III extended data leads to a Plenary…
- 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...
- 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 ...