ImetelChat

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...

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...

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...

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...

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...

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...

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...

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...

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...

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 ...

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 ...

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 ...

Yes, I agree. Unfortunately I don't drink anything stronger than coffee. But if I did, it would be Wild Turkey Liquor.

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...

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...

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...

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...

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...

Back in my management days, we estimated an employee’s benefits cost 30-35% of their salaries (e.g. medical, 401k/retirement, etc.)