NDA submitted

[biopearl123]

https://ir.geron.com/investors/press-re ... fault.aspx

[kmall]

Can you say HAPPY DANCE TIME ?!?!?!?!!!

Hallelujah......now FDA, let's get Imetelstat in the left friggin lane and cure some patients already!!! -Kmall

[LWS]

With the summitted NDA and an accelerated approval process in place, June (2023) will be remembered when the history of blood cancer treatments (especially telomeres and telomerase) is updated in new publications. Some of the remarks of the past need to be reviewed considering the recent and ongoing remarks from KOLs (Key Opinion Leaders).

=========================================

For Reference:

I don’t believe there will be a full buyout anytime soon. There is too much promise and potential now.

Mayo Clinic (Tantamount to a cure)
JS (Bigger than all of us)
Dr. Rizo (Remarkable and compelling)
MD Anderson (Numerous positive remarks)

All of the science and completed clinic trials have proven out for Imetelstat, with ongoing, confirming phase 3s in progress ( some now successfully completed). The preclinical testing (especially AML in combinations) has been very impressive. TELOMERE (clinical AML combinations) is just getting underway.

[LWS]

Mayo Clinic (Tantamount to a cure)
JS (Bigger than all of us)
Dr. Rizo (Remarkable and compelling)
MD Anderson (Numerous positive remarks)
==============================================================
Some believed that these remarks were exaggerated at best, and nonsense at worst. I believe Imetelstat has passed all expectations, and these remarks are right on target (NDA summitted).

From Mayo Clinic to MD Anderson with KOLs (Key Opinion Leaders) and Webinars, Imetelstat is now recognized for its unique role in treating various forms of blood cancer (ET, MDS, MF, AML) and beyond. Off-label uses will be closely watched, after the NDA is approved.

[LWS]

For Speculation and Off-Label Uses --- MF, AML and Beyond

Waiting for NDA Acceptance & Approval of Imetelstat

The ultimate (possible) cocktail : Venetoclax (AbbVie & TELOMERE)+ Imbruvica (JNJ) + Imetelstat (Geron --pending approval) + Azacitidine (AbbVie) + (????). The UK seems to be JNJ's choice for clinical AML evaluations and trials. Many have thought that the first Imetelstat approvals would come from the UK (MHRA).

=========================
Previous:

JNJ obviously has an interest in Imetelstat and JNJ-74856665 (with Venetoclax in UK, clinical AML). Of course, I don't know the details, and I am not a mind reader. As an investor, looking to the future, I see both AbbVie and JNJ being there (with their deep pockets) in some very important ways, fully supporting Geron and Imetelstat.

=========================

For Reference:

Venetoclax (approved -- AbbVie), Imbruvia (approved -- JNJ ) and Imetelstat (pending approval -- Geron) all kill cancer cells by different methods. Together, in combinations, there likely will be important synergies.

1/ Imetelstat (telomerase, an enzyme, inhibitor) -- kills cancer cells,
2/ Venetoclax (BCL-2 protein inhibitor) -- kills cancer cells
3/ Imbruvica is a targeted medicine that works by inhibiting the enzyme Bruton tyrosine kinase (BTK), which is part of a crucial signaling pathway in certain cancers, especially B-cell leukemias and lymphomas. By blocking this pathway Imbruvica triggers the death of cancer cells.

[Gwikley]

Any popular opinion as to why the NDA has not passed approval yet?
This particular wait as opposed to those in the past, seems interminable.
Thanks.
G.

[kmall]

Gwikley - I believe the FDA has 60 days to accept. Knowing Geron it will most likely be at minimum 59 days or more from submission until they get the yeah or nay for acceptance from the FDA.....and THEN the countdown for approval starts. -Kmall

[biopearl123]

Correctamundo. Gwickly, find a comfortable chair.

[LWS]

kmall--- Being Geron, we have learned to believe the worst outcome imaginable. Does Geron always have a 'black cloud' following it around? Considering KOLs, Webinars, MD Anderson and patients' immediate needs, I am much more optimistic that there will be both accelerated acceptances and approvals. I would hope for the good news (NDA approval) sometime in August. I still believe in the FDA, and putting patients' needs before all other considerations.

[realize]

Most likely after NDA acceptance they will have an Advisory Committee (kind of KOLs) to review and normally FDA goes by their suggestion even though it is not binding.

[LWS]

Good News Continues:

The NDA has been summitted. Acceptance and approval are done deals (IMO), with the EAP (extended and compassionate use) in place, patients' immediate needs (including off-label uses), disease modification, transfusion improvements, better survival times, observed CR's & PR's, and trial data that shows effectiveness with a good safety profile.

The KOLs and Webinars will continue to endorse Imetelstat.

[LWS]

The NDA was summitted on June 20, 2023. We are getting very close to the 60 day limit under "Fast Track designation". We all believe that the NDA will be accepted for review, and approved in a timely manner.

What could go wrong?
FUDD (Fear, Uncertainty, Doubt, Deception)
============================================================================

Telomerase Inhibitor Imetelstat
06/20/2023

“This pioneering achievement to submit the first New Drug Application to the FDA for a telomerase inhibitor reflects the dedication, commitment and teamwork of so many people who believed targeting telomerase could make a significant difference for patients,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We are deeply committed to addressing the unmet needs for lower risk MDS patients, who often suffer from transfusion-dependent anemia.”


As allowed under imetelstat’s Fast Track designation in lower risk MDS, Geron has requested that the FDA grant Priority Review of the NDA. Under standard practice, Geron expects FDA communication in 60 days whether the NDA was accepted for review and the timeline of such review (i.e., priority or standard). Additionally, based on IMerge Phase 3, Geron expects to submit a Marketing Authorization Application (MAA) in the EU in the second half of 2023.

[LWS]

By my calculation the 60 day waiting period started on June 20 and runs to August 18 (next Friday). We should hear sometime next week about acceptance of the NDA from the FDA, with a timeline for approval.

If all is silent, then I am missing something.

What could go wrong?
FUDD

[Zhears]

I have had a look just incase its 60 working days rather than 60 days and can't find anything to say it's not 60 days.
But then again, I would assume it was working days for something like this.

[KTArsenal]

If it wasn't 60 calendar days, then the FDA would have to specify as such, I believe.

https://www.accessdata.fda.gov/scripts/ ... fr=314.101

[Ryan]

Indeed. It will be either next Friday or the following Monday.

[Ryan]

Indeed. It will be either next Friday or the following Monday.

diting to point out, it *could* be earlier, it’s not against the law or anything lol, but why go even a day faster, lol again but not really a true happy lol!

[Ryan]

Indeed. It will be either next Friday or the following Monday.

Editing to point out, it *could* be earlier, it’s not against the law or anything lol, but why go even a day faster, lol again but not really a true happy lol!

[biopearl123]

I wonder if by taking its time to review the NDA now, Geron will be given a shorter PUDUFA date. In theory, since the application was granted rolling review, each module has already been closely examined by the FDA over an extended period of time with the possible exclusion of the last submitted module. If the drug were controversial I might think that further input from patients, families, and experts might be sought but there seem to be no red flags to date that we have been apprised of. For this reason I am not too worried about getting toward the end of the 60 NDA review period. Geron has been very careful to say they have spent a bundle on consultants who specialize in the FDA approval process. What’s left? Maybe “not much”, however John has managed expectations well and set the stage for an possible expert panel review yet to come. See you next week. Oh, and don’t worry too much about “cathy” on YMB. “She”, is a self proclaimed short seller, has disparaged this board, and has had the temerity to tangle with kmall in the past and come up short. Yes, we were all (with some notable exceptions as emphasized by kmall) burned by J and J. But that was 5 years ago. I hope we are all a little smarter now and can make up some of our losses. Everything we have heard suggests that patients, doctors and yes the FDA want approval. bp

[KTArsenal]

I suspect that the NDA will be approved. I am interested in how "fast track" will be applied as well.

Dr. Scarlett mentioned a few times that they were in contact with the FDA to help ensure that the new drug application process goes unhindered, but it will ultimately be their decision to approve imetelstat for MDS, obviously.