Search found 50 matches

by CKTC
Fri Mar 22, 2024 12:20 am
Forum: ImetelChat
Topic: Patients #3 and #9 had both been on Luspatercept.
Replies: 4
Views: 972

Re: Patients #3 and #9 had both been on Luspatercept.

I believe only six patients were in the trial with prior luspatercept exposure. This lack of data will be a problem for Geron once luspatercept overtakes ESAs in the frontline setting. Doctors will want to know if their luspatercept-failure patients will respond to imetelstat. Contrary to what Scarl...
by CKTC
Thu Mar 21, 2024 12:41 pm
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 31
Views: 6836

Re: FDA v. Geron

I don’t think the FDA will deny approval. The drug benefits a subset of patients who have failed ESAs. The agency may restrict the label regarding who can use the drug and for safety reasons. However, I see another issue the FDA may want Geron to address: the lack of data on luspatercept failures. L...
by CKTC
Wed Mar 20, 2024 5:54 pm
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 31
Views: 6836

Re: FDA v. Geron

"There were 12 instances where the FDA rejected a product that an advisory committee had recommended approval. Three were reviewed by the Endocrinologic and Metabolic Drugs Advisory Committee and two each by the Oncologic Drugs Advisory Committee, Anesthetic and Analgesic Drug Products Advisory Comm...
by CKTC
Fri Mar 15, 2024 12:55 pm
Forum: ImetelChat
Topic: A note from your board moderator
Replies: 3
Views: 971

Re: A note from your board moderator

@biopearl123 I have a theory as to why the FDA came out swinging so hard on the efficacy issue when it should seem obvious to most that the drug works. The real challenge for Geron with the FDA has been going on behind closed doors, and that’s the wording of imetelstat’s labeling. The drug’s side ef...
by CKTC
Thu Mar 14, 2024 10:02 pm
Forum: ImetelChat
Topic: Awesome Job by Dr. Faye Feller
Replies: 5
Views: 826

Re: Awesome Job by Dr. Faye Feller

Yes, she was amazing.
by CKTC
Thu Mar 14, 2024 8:31 pm
Forum: ImetelChat
Topic: Vote 12-2 in Favor
Replies: 9
Views: 1930

Vote 12-2 in Favor

Nice win for Geron, imetelstat, and MDS patients. Now we need FDA approval.
by CKTC
Wed Mar 13, 2024 5:03 pm
Forum: ImetelChat
Topic: CKTC
Replies: 8
Views: 1841

Re: CKTC

The FDA notes that the p-value of HI-E, according to the 2006 guidelines, is p=0.112. They didn’t come up with this themselves. The likely scenario is that Geron provided the numbers for the 2006 and 2018 guidelines and then made the case for why the 2018 numbers should be used. The trial protocol d...
by CKTC
Wed Mar 13, 2024 1:50 pm
Forum: ImetelChat
Topic: Basic Considerations....
Replies: 13
Views: 2529

Re: Basic Considerations....

Dr. Platzbacker designed the study that led to the IWG 2018 revisions, and led the panel that incorporated the changes into practice. https://ashpublications.org/blood/article/133/10/1020/272723/Proposals-for-revised-IWG-2018-hematological And as you can see from Dr. Platzbacker’s IMerge poster, ime...
by CKTC
Wed Mar 13, 2024 4:31 am
Forum: ImetelChat
Topic: Basic Considerations....
Replies: 13
Views: 2529

Re: Basic Considerations....

There’s a lot of negative bias in this FDA briefing doc. For example, two of the three efficacy issues the FDA raises (3.2 Efficacy Issues) make no sense to me. The first listed issue, magnitude and durability of RBC-TI vs. risk of treatment, is a legitimate question for the panel. However, the seco...
by CKTC
Wed Mar 13, 2024 2:20 am
Forum: ImetelChat
Topic: Basic Considerations....
Replies: 13
Views: 2529

Re: Basic Considerations....

I just read the FDA briefing doc and have a lot of questions regarding the data. For example, in its presentations, Geron always uses the 2018 revised IWG criteria for HI-E response which in the trial was statistically significant in favor of imetelstat vs placebo. But the FDA refers to the 2006 IWG...
by CKTC
Tue Mar 12, 2024 1:24 pm
Forum: ImetelChat
Topic: ADCOM Meeting
Replies: 1
Views: 686

ADCOM Meeting

https://www.fda.gov/advisory-committees/advisory-committee-calendar/march-14-2024-meeting-oncologic-drugs-advisory-committee-meeting-announcement-03142024#event-materials Once the Event Materials are posted, hopefully, today, the two PDF files everyone will want to look at are: • FDA Briefing Docume...
by CKTC
Tue Mar 12, 2024 12:24 pm
Forum: ImetelChat
Topic: Additional comments to FDA
Replies: 10
Views: 2621

Re: Additional comments to FDA

Dr. Hunter is the perfect addition to the ORDAC committee. The current roster includes two hematologists, but neither has a focus on myeloid malignancies. More importantly, Dr. Hunter's primary research focuses on understanding myeloid malignancies' molecular drivers. So, he should be especially int...
by CKTC
Sat Mar 09, 2024 7:03 pm
Forum: ImetelChat
Topic: Taking the temperature at the FDA
Replies: 5
Views: 1136

Re: Taking the temperature at the FDA

Stocks are always halted the day of the advisory committee meeting. Sometimes there will be pre-market and post-market trading. But during the actual meeting, the stock will be halted. Regarding the briefing documents, the law stipulates the FDA must release them no later than two days prior to the ...
by CKTC
Thu Feb 29, 2024 1:22 pm
Forum: ImetelChat
Topic: Absolutely fabulous comments from Dr. Jeffrey Savidge
Replies: 6
Views: 1553

Re: Absolutely fabulous comments from Dr. Jeffrey Savidge

Think about this: The first-line drug used all these years in low/intermediate risk MDS to treat anemia has a massive black-box warning. The FDA considered this drug class to be so dangerous they required a formal REMS certification for doctors who prescribed them. After being in place for almost fi...
by CKTC
Thu Feb 29, 2024 2:26 am
Forum: ImetelChat
Topic: Absolutely fabulous comments from Dr. Jeffrey Savidge
Replies: 6
Views: 1553

Re: Absolutely fabulous comments from Dr. Jeffrey Savidge

@biopearl The analysts had several questions today about the cytopenias. Scarlett tends to brush them off, but I think the ADCOM committee will take a hard look at the issue. Whatever the source of the cytopenias (damage/healing), they have to be dealt with, one way or another. We’ve only been privy...
by CKTC
Tue Jan 16, 2024 6:15 am
Forum: ImetelChat
Topic: A new Irish Trader? Hat tip to Paul C
Replies: 17
Views: 6345

Re: A new Irish Trader? Hat tip to Paul C

I’m trying to figure out how this individual could have started on imetelstat in January 2023. IMerge Phase 3 enrolled 178 patients between September 2019 and October 2021. There was an expansion phase that allowed patients to continue on imetelstat, which is still ongoing. However, this individual ...
by CKTC
Mon Dec 25, 2023 7:35 pm
Forum: ImetelChat
Topic: Putting 6-thio-Dg into perspective
Replies: 15
Views: 14393

Re: Putting 6-thio-Dg into perspective

biopearl123 That’s a good find! I wish I still had the mental bandwidth to research these applications. The original application was filed in 2011, and the patent was finally approved in 2022. Standard patent law provides 20-year exclusivity from the original filing date, so in this case, it is thro...
by CKTC
Thu Dec 21, 2023 2:34 pm
Forum: ImetelChat
Topic: CKTC
Replies: 2
Views: 2898

Re: CKTC

I don’t think THIO’s advantages over imetelstat are only theoretical. In addition to overcoming the lag time and telomere length issues, the drug has a very clear dual MOA: telomere targeting and immunogenic. Its immunogenic effect and benign safety profile allow it to be paired with any of the chec...
by CKTC
Wed Dec 20, 2023 6:06 am
Forum: ImetelChat
Topic: Putting 6-thio-Dg into perspective
Replies: 15
Views: 14393

Re: Putting 6-thio-Dg into perspective

Maia’s drug THIO (6-thio-2′-deoxyguanosine, aka 6-thio-dG) is a nucleoside. Geron’s imetelstat is a nucleotide, or rather, an oligonucleotide, which is a small nucleotide. Chemically, a nucleoside contains a nitrogen base and a sugar. A nucleotide contains a nitrogen base, a sugar, and a phosphate. ...
by CKTC
Wed Aug 23, 2023 8:04 pm
Forum: ImetelChat
Topic: Here’s maybe why we didn’t get priority
Replies: 19
Views: 9481

Re: Here’s maybe why we didn’t get priority

@biopearl123 Luspatercept received FDA priority review for its recent supplemental BLA for anemia as a first-line treatment vs. ESA’s in low/intermediate risk MDS. It did not receive priority review for its original BLA in MDS patients failing ESA’s. It did receive orphan drug and fast track designa...