Search found 255 matches
- Mon May 13, 2024 4:05 am
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 45
- Views: 12635
Re: FDA v. Geron
Good question jayfish101. Maybe Hoosier Investor could address how restrictive the FDA label would be in this case regarding off label usage and how doctors would proceed. Without Medicare/ supplemental insurance, it would be very expensive for any patient and I doubt without biomarkers increasing t...
- Mon May 13, 2024 1:52 am
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 45
- Views: 12635
Re: FDA v. Geron
Again, thank you Hoosier Investor for your thoughts on if Imetelstat could be used by patients R/R to Luspatercept. This then would become an unmet need by LR MDS patients who have become R/R while being treated with Luspatercept, even though a possible life extending benefit for many with Imetelsta...
- Wed May 08, 2024 7:07 pm
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 45
- Views: 12635
Re: FDA v. Geron
Thanks Hoosier Investor for your detailed and thoughtful reply. I appreciate your understanding of the process going on between the FDA and Geron as well as your confidence in and interpretation of the tea leaves leading to likely approval for Imetelstat. Very helpful to me and I suspect other board...
- Tue May 07, 2024 5:06 am
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 45
- Views: 12635
Re: FDA v. Geron
I have a couple questions I would appreciate if maybe some members here could help shed some light on. While I believe the FDA was throwing out misleading statements (maybe flagrantly) while manipulating statistics to support their obvious air balls, a couple points might have some bearing but hopef...
- Mon May 06, 2024 12:08 am
- Forum: ImetelChat
- Topic: 12-2, take the win right?
- Replies: 13
- Views: 6035
Re: 12-2, take the win right?
I have a propensity to positive confirmation bias and IMO we as a group find it difficult for anyone to not see the value and potential of Imetelstat for both patients and investors. In addition, we have come to recognize the leadership and talented employees Geron has brought on board helping it to...
- Wed Apr 17, 2024 3:54 am
- Forum: ImetelChat
- Topic: 12-2, take the win right?
- Replies: 13
- Views: 6035
Re: 12-2, take the win right?
I cringe to think what the FDA would have done absent the ODAC and the 12-2 vote. I originally thought the ODAC was basically just another FDA hurdle they would misuse to create additional issues for Geron/Imetelstat on their path to commercialization. While I was likely right regarding the FDA’s in...
- Mon Apr 15, 2024 6:03 pm
- Forum: ImetelChat
- Topic: Why is this man smiling? Or, the thing about good studies
- Replies: 3
- Views: 1176
Re: Why is this man smiling? Or, the thing about good studies
At the Needham fireside chat I think Dr. John Scarlett was more upbeat than I have ever seen him. He made several comments that reflected his enthusiasm and confidence that both patients and investors would be rewarded for their patience. Of course, he also reiterated many of the key points from pas...
- Sun Apr 14, 2024 8:29 pm
- Forum: ImetelChat
- Topic: 12-2, take the win right?
- Replies: 13
- Views: 6035
Re: 12-2, take the win right?
Thanks, biopearl123 for your excellent thoughts on the possible impacts on the FDA because of the ODAC meeting. You are on point for sure that it is an evolutionary process and people’s minds are changed with education. I am hopeful the FDA will approve MDS ahead of the PDUFA date of June 16 as they...
- Sat Apr 06, 2024 8:34 pm
- Forum: ImetelChat
- Topic: RYTELO
- Replies: 4
- Views: 1748
RYTELO
Many of you may have known that RYTELO is the proposed trade name for Imetelstat. Anyway it was included in the FDA’s briefing document for the ODAC. “ Executive Summary Purpose/Objective of the AC Meeting The Applicant is seeking approval of imetelstat (proposed trade name RYTELO) for the treatment...
- Wed Mar 27, 2024 9:16 pm
- Forum: ImetelChat
- Topic: Take me to your leader
- Replies: 5
- Views: 2607
Re: Take me to your leader
Definitely agree with Bigfun and second on the thanks to rccola335 for the links. It's always good to get Dr. John Scarlett's thoughts on where things stand and how hew he perceives the future, especially the next few months. Secondly, I would hope minimally board members could check out the second ...
- Wed Mar 27, 2024 5:38 pm
- Forum: ImetelChat
- Topic: 12-2, take the win right?
- Replies: 13
- Views: 6035
Re: 12-2, take the win right?
Thanks biopearl123 for all your time, efforts and attention to detail. You have again laid out several really important points/observations from the ODAC meeting on 3/14. As usual, you have taken the high road and we all admire your character and discipline in that regard. I for one, prefer to take ...
- Wed Mar 27, 2024 5:22 pm
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 45
- Views: 12635
Re: FDA v. Geron
I have watched Geron and its stock and have been an investor for a very long time. Certainly not the longest here, maybe even just average. I know there are many old timer investors here that are determined to see this through, many of us well over a decade and some even decades. Most of us know of ...
- Thu Mar 14, 2024 10:54 pm
- Forum: ImetelChat
- Topic: March 14th
- Replies: 27
- Views: 5995
Re: March 14th
Yes, I agree. Unfortunately I don't drink anything stronger than coffee. But if I did, it would be Wild Turkey Liquor.
- Thu Mar 14, 2024 10:49 pm
- Forum: ImetelChat
- Topic: Awesome Job by Dr. Faye Feller
- Replies: 5
- Views: 932
Re: Awesome Job by Dr. Faye Feller
Agreed! I have always believed that Dr. Faye Feller was made for the CMO job, especially after watching the interview video link posted here long ago. She has also obviously grown into the job from her original strong underpinnings to be able to give the stellar performance we saw today. I know a lo...
- Thu Mar 14, 2024 8:48 pm
- Forum: ImetelChat
- Topic: March 14th
- Replies: 27
- Views: 5995
Re: March 14th
Vote was 12-2 as follows: 1. AC-Joan Powell YES 2. AC-Ravi Madan(Chair) NO 3. AC-Neil Vasan YES 4. AC-Jorge Nieva YES 5. AC-Daniel Spratt YES 6. AC_Christopher Lieu YES 7. AC-Ashley Rosko YES 8. AC-Mark Conaway NO 9. AC-Anthony Hunter YES 10. AC-David Mitchell YES 11. AC-Toni Choueiri YES 12. AC-Pam...
- Thu Mar 14, 2024 6:24 pm
- Forum: ImetelChat
- Topic: March 14th
- Replies: 27
- Views: 5995
Re: March 14th
Maybe my glasses are just to rose colored but while the FDA may have a right and need to play the devil’s advocate role, there is no justification for misconstruing the facts on AE’s or misusing statistics to water down the various strengths and stellar results of the CTs whose design they signed of...
- Wed Feb 07, 2024 7:09 am
- Forum: ImetelChat
- Topic: Impress Study
- Replies: 3
- Views: 1283
Re: Impress Study
Based on our experience, I would never under estimate the number of monkey wrenches the FDA is so blatantly willing to use to delay approval or continue to maintain its all out assault on any CT using Imetelstat. However, were we ever specifically/exactly certain what all the FDA was looking for out...
- Wed Jan 17, 2024 6:43 pm
- Forum: ImetelChat
- Topic: MDS foundation - first post I read
- Replies: 8
- Views: 2130
Re: MDS foundation - first post I read
Members probably know this but the EAP is not available in India or anywhere outside of USA. Per the Geron website: The imetelstat expanded access protocol (EAP) is a U.S.-only protocol for eligible adult participants diagnosed with lower risk (very low, low, intermediate risk by IPSS-R) myelodyspla...
- Thu Jan 11, 2024 10:54 pm
- Forum: ImetelChat
- Topic: 50 New Positions Posted Today.........
- Replies: 11
- Views: 4796
Re: 50 New Positions Posted Today.........
Back in my management days, we estimated an employee’s benefits cost 30-35% of their salaries (e.g. medical, 401k/retirement, etc.)
- Mon Jan 08, 2024 5:55 pm
- Forum: ImetelChat
- Topic: todays presentation
- Replies: 5
- Views: 1439