Search found 250 matches
- Wed Apr 17, 2024 3:54 am
- Forum: ImetelChat
- Topic: 12-2, take the win right?
- Replies: 10
- Views: 4137
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: 1109
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: 10
- Views: 4137
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: 1664
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: 1915
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: 10
- Views: 4137
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: 35
- Views: 9892
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: 5707
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: 883
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: 5707
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: 5707
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: 1236
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: 2028
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: 4656
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: 1377
- Mon Jan 08, 2024 5:54 pm
- Forum: ImetelChat
- Topic: todays presentation
- Replies: 5
- Views: 1377
- Tue Dec 05, 2023 6:07 pm
- Forum: ImetelChat
- Topic: Why is the FDA Investigating CAR T Therapy?
- Replies: 0
- Views: 7286
Why is the FDA Investigating CAR T Therapy?
This article was interesting to me from several perspectives. It’s not a long read and has several striking quotes. And comparing the dance around CAR-T therapy’s issues compared to Dr. Patnaik’s comments in Lance is just another example to me of the subversive cabal working against Imetelstat comme...
- Tue Dec 05, 2023 5:43 pm
- Forum: ImetelChat
- Topic: Dr. Patnaik, editorial comment in Lancet
- Replies: 10
- Views: 17803
Re: Dr. Patnaik, editorial comment in Lance
Yes, great summary biopearl123. And to pile on kmall’s post, there is clearly something not right about the aim of Dr. Patnaik’s comments. I would suggest ulterior motives or just inept, could be both. I don’t think I’m paranoid here but I just find it hard to trust anyone or entity that continues a...
- Tue Nov 28, 2023 5:29 pm
- Forum: ImetelChat
- Topic: New Board Member
- Replies: 9
- Views: 9181
Re: New Board Member
Dr. Aggarwal has been on our radar since the VIVO Capital buy-in. http://imetelchat.imetelstat.eu/imetelchat.imetelstat.eu/viewtopic.php?f=1&t=1247&p=4004&hilit=Vivo+Capital#p4004 Not sure why he is no longer employed there, I guess it does allow JS to make this comment in the announcement: "Dr. Agg...
- Fri Nov 17, 2023 9:48 pm
- Forum: ImetelChat
- Topic: Keeping perspective
- Replies: 18
- Views: 34202
Re: Keeping perspective
mistergern, yes many of us here have been steadfast with our GERN stock positions. Maybe wrongly so however, I think instead of bashing Dr Scarlett and company, let’s not lose sight of the responsible parties for the most grievous offenses of incessant delays, ignoring great and unique results, road...