Search found 250 matches

by huntingonthebluffs
Wed Apr 17, 2024 3:54 am
Forum: ImetelChat
Topic: 12-2, take the win right?
Replies: 9
Views: 3358

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...
by huntingonthebluffs
Mon Apr 15, 2024 6:03 pm
Forum: ImetelChat
Topic: Why is this man smiling? Or, the thing about good studies
Replies: 3
Views: 1048

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...
by huntingonthebluffs
Sun Apr 14, 2024 8:29 pm
Forum: ImetelChat
Topic: 12-2, take the win right?
Replies: 9
Views: 3358

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...
by huntingonthebluffs
Sat Apr 06, 2024 8:34 pm
Forum: ImetelChat
Topic: RYTELO
Replies: 4
Views: 1569

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...
by huntingonthebluffs
Wed Mar 27, 2024 9:16 pm
Forum: ImetelChat
Topic: Take me to your leader
Replies: 5
Views: 1658

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 ...
by huntingonthebluffs
Wed Mar 27, 2024 5:38 pm
Forum: ImetelChat
Topic: 12-2, take the win right?
Replies: 9
Views: 3358

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 ...
by huntingonthebluffs
Wed Mar 27, 2024 5:22 pm
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 35
Views: 9423

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 ...
by huntingonthebluffs
Thu Mar 14, 2024 10:54 pm
Forum: ImetelChat
Topic: March 14th
Replies: 27
Views: 5592

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.
by huntingonthebluffs
Thu Mar 14, 2024 10:49 pm
Forum: ImetelChat
Topic: Awesome Job by Dr. Faye Feller
Replies: 5
Views: 854

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...
by huntingonthebluffs
Thu Mar 14, 2024 8:48 pm
Forum: ImetelChat
Topic: March 14th
Replies: 27
Views: 5592

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...
by huntingonthebluffs
Thu Mar 14, 2024 6:24 pm
Forum: ImetelChat
Topic: March 14th
Replies: 27
Views: 5592

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...
by huntingonthebluffs
Wed Feb 07, 2024 7:09 am
Forum: ImetelChat
Topic: Impress Study
Replies: 3
Views: 1196

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...
by huntingonthebluffs
Wed Jan 17, 2024 6:43 pm
Forum: ImetelChat
Topic: MDS foundation - first post I read
Replies: 8
Views: 1914

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...
by huntingonthebluffs
Thu Jan 11, 2024 10:54 pm
Forum: ImetelChat
Topic: 50 New Positions Posted Today.........
Replies: 11
Views: 4498

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.)
by huntingonthebluffs
Tue Dec 05, 2023 6:07 pm
Forum: ImetelChat
Topic: Why is the FDA Investigating CAR T Therapy?
Replies: 0
Views: 7206

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...
by huntingonthebluffs
Tue Dec 05, 2023 5:43 pm
Forum: ImetelChat
Topic: Dr. Patnaik, editorial comment in Lancet
Replies: 10
Views: 17757

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...
by huntingonthebluffs
Tue Nov 28, 2023 5:29 pm
Forum: ImetelChat
Topic: New Board Member
Replies: 9
Views: 9129

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...
by huntingonthebluffs
Fri Nov 17, 2023 9:48 pm
Forum: ImetelChat
Topic: Keeping perspective
Replies: 18
Views: 34150

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...