ImetelChat

Yes, late 2027 or early 2028 is the earliest timeline for Rytelo to be officially approved and marketed specifically for Myelofibrosis MF
While it is frustrating that a drug proven to save lives in a trial must wait over a year to get approved for those patients, the timeline cannot be shortened any ...

If the FDA convenes an Oncologic Drugs Advisory Committee ODAC meeting for the IMpactMF trial data, Geron's representation will consist of a highly structured panel divided into three core categories: Executive Leadership, Internal Clinical Experts, and External Key Opinion Leaders KOLsBased on ...

Interesting thoughts by HODL on Yahoo Finance:

it means the interim analysis has crossed the prespecified statistical boundary for Overall Survival OS
This indicates that imetelstat Rytelo shows a clear, undeniable survival benefit over the best available therapy for relapsed/refractory ...

biopearl123, very eloquent explanation as usual! I agree and believe we have been inadvertently sucked down the rabbit hole with the Kuykendall et al. real-world analysis using the Flatiron Health database. Many of us were unable to logically reach any other conclusion.

All the BAT options ...

From my layman's perspective, are we over complicating due to the confusion around the Kuykendall et al. real-world analysis, etc.? Obviously that analysis is important but does it say anything about why patients with intermediate-2 or high-risk MF are becoming R/R to Jak inhibitors sooner? And if ...

https://www.google.com/search?q=have+primary+and+secondary+endpoit+measures+in+a+clinical+trial+ever+been+allowed+to+change+when+cicumstances+change%3F&rlz=1CDGOYI_enUS745US745&oq=have+primary+and+secondary+endpoit+measures+in+a+clinical+trial+ever+been+allowed+to+change+when+cicumstances+change%3F ...

We all know rules are very important, especially in the CT setting. However, I would never say never and my 80+ years have taught me that every rule can have an exception. When circumstances are significantly different, exceptions can and need to be the rule.

Here we have a drug that is known to ...

Well, I am becoming more cynical and jaded on how impossible it seems to get a worthy and desperately needed drug to approval. As far as I'm concerned, innovative leadership at the FDA is an oxymoron! I'm still waiting on using RWD to speed things up. How many years has it been since floating that ...

I also received the same email from Geron asking for me to confirm my email address. It did look very legit.

biopearl123, awesome analysis and thoughts as usual! Our approval and expectations are rising for our CEO as we recognize his confidence and knowledge, and willingness to act!

It has to help for him to know that RYTELO is something very special and at this point, "Holy Grail" might just be the ...

I agree, Faye gave a great presentation. And like the moderator said, it was on a level most could understand.

A couple points she emphasized regarding IMpactMF cytopenias was that while grade 3-4 neutropenia's were frequently experienced, there were generally no infections, and though low ...

Provided by DAWGnuts re Stifel recap and transcript.

https://www.investing.com/news/transcri ... CH-4349536

Provided by Huntlardo24 on Stocktwits re Dr Faye Feller’s “new” job at Geron. “ $GERN for those wondering where the former CMO is, hear for your self from her. shes in a new role at geron, chief development officer;

https://youtu.be/P4kHn2Dp9Jk


I am having trouble with the link, so if you are as ...

Thanks biopearl123, that certainly makes sense!

While this is all far above my pay grade, it seems to me that given the class of chemotherapy called hypomethylating agents (HMA) reduces Rytelo's efficacy and given most of Geron’s CT's and approval in LR-MDS are for patients who have already ...

HODL Baby HODL on YMB points out that since Imetelstat is not effective post HMA's per the CEO/CMO comments on the Stifel fireside, the IMpress trial will have very limited results.

I’m not sure of implications for the IMAGINE CT but seems Geron and FDA were going down an unproductive path with ...

Is there such a thing as co-CMOs? Since so many of us have emailed Investor Relations and probably other parts of Geron (e.g. Human Relations) as well, to no avail, there is plenty of mystery to go around. Can’t wait for the explanation and it will happen in some form. Just hope when explanation ...

Yes absolutely spot on regarding Dr Faye Feller, Geron’s CMO (apparently former) IMO. I thought she was perfect for the job, based resume, per her statements regarding her career goals and path, and of course navigating the FDA hostilities, CT activity, etc. Since nothing has been announced I assume ...

I always find these write-ups and reports about the MPN diseases of value in understanding the challenges of dealing, surviving, treating and coping, etc. as both a patient and caregiver.

I hope while we have this down time before earnings and as organizational changes are being implemented some ...

As some already know, it looks like Faye Feller is no longer CMO per the Geron leadership page. Joseph Eid, M.D. EVP Research and Development, is also the Chief Medical Officer. Seems that should have been announced but haven’t seen anything anywhere yet.

https://www.geron.com/about/leadership/

I understand MDS is not an MPN, but it seems to be more semantics than anything.

From Patient Power per Hetty Carraway, MD, Associate Professor: Dr. Hetty Carraway is an oncologist in Chagrin Falls, Ohio and is affiliated with Cleveland Clinic. She received her medical degree from University of ...