ImetelChat

I believe there has been some speculation that High risk and Low risk MDS were separate diseases. If so, is Intermediate risk also a separate diagnosis/disease?

You said, "The FDA and Geron will be focused on hematologic improvement in LR/MDS which is quite impressive in the 60-70% range. "
But there seems to be the inclusion of intermediate risk also.

I was surprised to note that its not just being reviewed for low risk, but also for intermediate risk. Agenda The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The Committee will discuss new drug application (NDA) 217779 for imetels...

Novartis noted that its Phase 3 STIMULUS of Sabatolimab (MBG453) to treat Myelodysplastic syndromes (MDS) did not meet its primary endpoint,

I agree with you biopearl. I hope its just a matter of the market slow to digest the news, as often is the case with geron. The March evaluation and recommendations fit better with Geron plan to launch product in June. Hmm. Never understood how they could plan for that with PDUFA in mid June, but no...

Item 8.01 Other Events. As previously disclosed, in August 2023, Geron Corporation (“Geron” or the “Company”) announced that its New Drug Application (“NDA”) for the use of imetelstat for the treatment of transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk myelodysplastic ...

I do not see Geron on the March FDA calendar. I do see the PDUFA in June calendar. GERN GERON CORPORATION PDUFA When Sunday, Jun 16, 2024 Description 2024-06-16 Investors are cautioned that such statements, include, without limitation, those regarding: (i) that FDA has assigned a PDUFA action date o...

ImmunityBio's (IBRX) bladder cancer therapy Anktiva, Verona Pharma's (VRNA) non-steroidal
COPD therapy, ensifentrine, and Geron's (GERN) blood cancer therapy, Imetelstat, round out the
list.

01/26/2024

Geron Corporation has added a new SEC filing to its website:

SC 13G/A (Amended Statement of Ownership)

6. SHARED VOTING POWER 24,443,571 7. SOLE DISPOSITIVE POWER 0 SHARES 8. SHARED DISPOSITIVE POWER 25,625,606 9. AGGREGATED AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON 25,625,606 10. CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES NOT APPLICABLE 11. PERCENT OF CLASS REPRESE...

Interesting item I excerpted from a continuing education quiz for doctors that I received via Clinical Care Options and Amer Zeidan MBBS, MPH A patient with lower-risk non-del(5q) MDS has been requiring approximately 4 units of RBCs every 4 weeks for the past 6 months. Iron studies, platelets, and w...

And I was just ruminating about why we have not heard from patients who were granted access to Imetelstat. I wonder if Geron gets feedback on those patients.

Well stated, Biopearl. I have personally been to a number of these pay for use perk vacation/seminars. I nearly was involved in the DSM 5 redo. I am glad my name is not attached to that joke book.

DSM-5 Panel Members Received $14.2M in Industry Funding: Study Published: Jan 11, 2024 By Tristan Manalac depression_iStock, simpson33 Pictured: A woman sits in the dark/iStock, simpson33 Around 60% of physicians who had served as panelists or task force members of the fifth edition of the American ...

I wonder if the FDA pays attention to the ICER findings.

So they increased their loan. And also
Tightened up board nominating?
Help? Hard to understand filings

Please elaborate on your comment. I think you are saying no plenary for Geron, but in what context are you speaking? And what are the possible ramifications of that?

It seems new to me that intermediate and high risk MDS patients were studied and that the results are as positive if not more so than for the low risk MDS patients.

Syros Pharmaceuticals (NASDAQ: SYRS) announced initial data from its Phase 2 SELECT-AML-1 trial evaluating tamibarotene with venetoclax and azacitidine in newly diagnosed, unfit patients with acute myeloid leukemia (AML) and RARA gene overexpression. The preliminary data resulted in a 100% CR/CRi ra...

Good news! And it arrived around the time last projected.