WE ARE APPROVED
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- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
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biopearl123
- Posts: 2591
- Joined: Fri Jul 20, 2018 5:13 pm
Re: WE ARE APPROVED
Ok, both of you guys will have your most recent posts deleted as soon as I can get to my computer a little later.
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LWS
Re: WE ARE APPROVED
Pending approval and access by patients in various parts of Europe (EMA and MHRA in the UK)
https://everyone.org/blog/geron-imetelstat-ema-approval
Geron's Rytelo/imetelstat: When is EMA approval coming for the newest MDS treatment?
When is the new treatment for MDS going to be available to patients outside the USA?
everyone.org
Also, as September begins the focus is now on ASH2024 abstracts and Rytelo.
https://everyone.org/blog/geron-imetelstat-ema-approval
Geron's Rytelo/imetelstat: When is EMA approval coming for the newest MDS treatment?
When is the new treatment for MDS going to be available to patients outside the USA?
everyone.org
Also, as September begins the focus is now on ASH2024 abstracts and Rytelo.
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LWS
Re: WE ARE APPROVED
Most on this board believe that EMA and MHRA approvals are inevitable, but no one knows exactly when. At that time, many believe that Geron will decide on a European partner or collaborator with deep pockets. Both Novo Nordisk and Novartis have been mentioned. Here are their current products. Novartis is already in the oncology business, while Novo Nordisk likely wants to get into the oncology business.
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Company Summary
Novartis is a Swiss-based pharmaceuticals company. Key products include Cosentyx (psoriasis, PSA and AS), Entresto (heart failure), Kisqali (breast cancer), Pluvicto (prostate cancer), Kesimpta (multiple sclerosis) and Scemblix (chronic myeloid leukemia)
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Company Summary
Novo Nordisk is a Denmark-based world leader in insulin, diabetes and obesity care and also manufactures and markets a variety of other pharmaceutical products. Key products include Wegovy and Semaglutide (GLP-1) and long-acting basal insulins.
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Company Summary
Novartis is a Swiss-based pharmaceuticals company. Key products include Cosentyx (psoriasis, PSA and AS), Entresto (heart failure), Kisqali (breast cancer), Pluvicto (prostate cancer), Kesimpta (multiple sclerosis) and Scemblix (chronic myeloid leukemia)
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Company Summary
Novo Nordisk is a Denmark-based world leader in insulin, diabetes and obesity care and also manufactures and markets a variety of other pharmaceutical products. Key products include Wegovy and Semaglutide (GLP-1) and long-acting basal insulins.
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LWS
Re: WE ARE APPROVED
Approvals and Availability in Europe
When it comes to Europe, the process of gaining EMA approval for imetelstat is already underway. Geron's marketing authorization application for the medicine was validated in October 2023. Hopefully, the approval in Europe is just a matter of a bit more time and we will have some positive news soon.
Approval and availability are unfortunately not the same thing. While imetelstat's EMA approval seems just around the corner, it will still take some time until the treatment is available across Europe.
Each EU member state launches EMA-approved medicines at their own pace. Some, like Germany, are relatively quick, with an average launch time of 100 days for oncological treatments. At the other end of the spectrum is Romania, where it takes an average of 964 days for a new cancer treatment to become available.
In other words, imetelstat could theoretically become available in some EU countries towards the end of 2024. That's assuming that the medicine will get EMA approval by September 2024. Other EU countries may have to wait for another couple of years.
In the UK, imetelstat holds the Innovation Passport Designation. This designation offers an expedited review pathway.
While this is positive news, there is no specific timeline for imetelstat's MHRA approval. Theoretically, a UK approval could be a fact within 2024, if the MHRA follows the International Reliance Procedure. However, only time will tell if that's the direction they go.
If the MHRA approves Rytelo soon, the medicine will then require a NICE assessment before becoming available on the NHS. If approved, the medicine should be available to UK patients within three months of the NICE's decision date.
NICE has already initiated an assessment of imetelstat. However, it is currently suspended, meaning that there is no decision-making timeline available at the moment.
Assuming a best-case scenario, where the MHRA approves imetelstat by the end of 2024, and NICE makes a positive decision soon after, the treatment could be available in the UK by mid-2025. However, note that this is only a theoretical timeline and the MHRA's actions in the next months will determine whether it's realistic.
The National Institute for Health and Care Excellence (NICE) is an executive non-departmental public body, in England, of the Department of Health and Social Care, that publishes guidelines in four areas:
1/ the use of health technologies within England's National Health Service (NHS) and NHS Wales (such as the use of new and existing medicines, treatments and procedures)
2/ clinical practice (guidance on the appropriate treatment and care of people with specific diseases and conditions)
3/ guidance for public sector workers on health promotion and ill-health avoidance
4/ guidance for social care services and users.
When it comes to Europe, the process of gaining EMA approval for imetelstat is already underway. Geron's marketing authorization application for the medicine was validated in October 2023. Hopefully, the approval in Europe is just a matter of a bit more time and we will have some positive news soon.
Approval and availability are unfortunately not the same thing. While imetelstat's EMA approval seems just around the corner, it will still take some time until the treatment is available across Europe.
Each EU member state launches EMA-approved medicines at their own pace. Some, like Germany, are relatively quick, with an average launch time of 100 days for oncological treatments. At the other end of the spectrum is Romania, where it takes an average of 964 days for a new cancer treatment to become available.
In other words, imetelstat could theoretically become available in some EU countries towards the end of 2024. That's assuming that the medicine will get EMA approval by September 2024. Other EU countries may have to wait for another couple of years.
In the UK, imetelstat holds the Innovation Passport Designation. This designation offers an expedited review pathway.
While this is positive news, there is no specific timeline for imetelstat's MHRA approval. Theoretically, a UK approval could be a fact within 2024, if the MHRA follows the International Reliance Procedure. However, only time will tell if that's the direction they go.
If the MHRA approves Rytelo soon, the medicine will then require a NICE assessment before becoming available on the NHS. If approved, the medicine should be available to UK patients within three months of the NICE's decision date.
NICE has already initiated an assessment of imetelstat. However, it is currently suspended, meaning that there is no decision-making timeline available at the moment.
Assuming a best-case scenario, where the MHRA approves imetelstat by the end of 2024, and NICE makes a positive decision soon after, the treatment could be available in the UK by mid-2025. However, note that this is only a theoretical timeline and the MHRA's actions in the next months will determine whether it's realistic.
The National Institute for Health and Care Excellence (NICE) is an executive non-departmental public body, in England, of the Department of Health and Social Care, that publishes guidelines in four areas:
1/ the use of health technologies within England's National Health Service (NHS) and NHS Wales (such as the use of new and existing medicines, treatments and procedures)
2/ clinical practice (guidance on the appropriate treatment and care of people with specific diseases and conditions)
3/ guidance for public sector workers on health promotion and ill-health avoidance
4/ guidance for social care services and users.
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LWS
Re: WE ARE APPROVED
ASH2024 ---Abstracts available online November 5, 2024, 9:00 a.m. Eastern time
The 66th ASH Annual Meeting and Exposition will be held in San Diego, California from December 7-10, 2024. The event will take place at the San Diego Convention Center, located at 111 W Harbor Drive, San Diego, CA 92101.
Geron needs (and is obtaining) several types of partners or collaborators (manufacturing, distribution, research, deep pockets) as Rytelo (imetelstat) (and perhaps other oligonucleotides) wait for European approvals (EMA, MHRA) and ramps up production for immediate use in the USA and for additional research for various blood cancers and beyond.
Potential ASH2024 subjects: Here are five current Rytelo topics that Geron and potential partners are thinking about:
1/ Ferroptosis
2/ Telomerase & Telomeres
3/ Combinations
4/ Synergies
5/ Oral form potential
The 66th ASH Annual Meeting and Exposition will be held in San Diego, California from December 7-10, 2024. The event will take place at the San Diego Convention Center, located at 111 W Harbor Drive, San Diego, CA 92101.
Geron needs (and is obtaining) several types of partners or collaborators (manufacturing, distribution, research, deep pockets) as Rytelo (imetelstat) (and perhaps other oligonucleotides) wait for European approvals (EMA, MHRA) and ramps up production for immediate use in the USA and for additional research for various blood cancers and beyond.
Potential ASH2024 subjects: Here are five current Rytelo topics that Geron and potential partners are thinking about:
1/ Ferroptosis
2/ Telomerase & Telomeres
3/ Combinations
4/ Synergies
5/ Oral form potential
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LWS
Re: WE ARE APPROVED
New approvals needed --- Rytelo has been approved by the FDA. However, before the PPS can get to over $5 (and stay there), the confirmation approvals from the Europeans (EMA, MHRA/UK) must be a matter of record. The speculation has been all over the place from next week, in October, before ASH2024 to sometime in 2025. These approvals are necessary for the PPS to move to the next level. These approvals seem to be assured, but with Geron, timelines are impossible to pin down and surprises happen.
Re: WE ARE APPROVED
Geron in their corporate presentation for september said again early 2025 - they have been consistent on that time frame
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LWS
Re: WE ARE APPROVED
rccola -We will have to wait and see. JS (IMHO) would tend to be very conservative (considering previous lawsuits) about anything that he would say to the public about any future European approvals. I am hoping that at least one of the approvals (EMA, MHRA/UK) would occur in 2024 (perhaps before ASH2024).
The time that has passed has already been greater than usual. Considering that the FDA approval was clean (no black box labels), I see no special problems.
Dr. Mascarenas when presenting imetelstat for MF called it "a game changer" (from rccola)
The time that has passed has already been greater than usual. Considering that the FDA approval was clean (no black box labels), I see no special problems.
Dr. Mascarenas when presenting imetelstat for MF called it "a game changer" (from rccola)
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LWS
Re: WE ARE APPROVED
As we sit on our hands waiting for European approvals, I am reflecting on some of the comments from past days. Are they valid or are they exaggerations?
EMA and MHRA/UK approvals appear to be very likely, but one never knows until it happens. These approvals are a necessity for the investment community to take Rytelo seriously. The scientific community is mostly on board, I believe. ASH2024 should provide some important answers.
Perhaps, it is still too early to tell as Geron focuses on 3 blood cancers (MDS, MF, AML), new formulations (IMET2.O, compound #2, oral, patents, off-label, etc.) and as a complement to chemotherapy.
1/ Tantamount to (looks like) a cure -- Dr. Tefferi
2/ Bigger than all of us -- John Scarlett
3/ Remarkable, durable, compelling --- Dr. Rizo
4/ Game changer --- Dr. Mascarenas
5/ Synergies in combinations (preclinical) --- published paper
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We should expect Geron to publicly acknowledge (Compound #2) in the near future. Compound #2 appears to be on par (or better) than IMET + Venetoclax in terms of efficacy based on the mice studies. The oral deliver aspect is certainly better. However, we don't have any idea of toxicity comparison of the two options. I'd guess this study is the main IMET2.0 effort. It would be quite a pleasant surprise if we ultimately learn this is only one of the IMET2.0 compounds for further study. --- From Hoosier
EMA and MHRA/UK approvals appear to be very likely, but one never knows until it happens. These approvals are a necessity for the investment community to take Rytelo seriously. The scientific community is mostly on board, I believe. ASH2024 should provide some important answers.
Perhaps, it is still too early to tell as Geron focuses on 3 blood cancers (MDS, MF, AML), new formulations (IMET2.O, compound #2, oral, patents, off-label, etc.) and as a complement to chemotherapy.
1/ Tantamount to (looks like) a cure -- Dr. Tefferi
2/ Bigger than all of us -- John Scarlett
3/ Remarkable, durable, compelling --- Dr. Rizo
4/ Game changer --- Dr. Mascarenas
5/ Synergies in combinations (preclinical) --- published paper
=========
We should expect Geron to publicly acknowledge (Compound #2) in the near future. Compound #2 appears to be on par (or better) than IMET + Venetoclax in terms of efficacy based on the mice studies. The oral deliver aspect is certainly better. However, we don't have any idea of toxicity comparison of the two options. I'd guess this study is the main IMET2.0 effort. It would be quite a pleasant surprise if we ultimately learn this is only one of the IMET2.0 compounds for further study. --- From Hoosier
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LWS
Re: WE ARE APPROVED
We still do not know what compound #2 is composed of, but likely it has exceeded the results in the reference material, perhaps with an oral path.
I don't believe Geron would be so aggressive unless they were totally confident in Rytelo and its future. The European approvals seem ensured, but one never knows until it happens. We are waiting for some IMpress (AML clinical, Rytelo/imetelstat alone) interim information and progress on TELOMERE (AML, imetelstat with venetoclax clinical) which now appears to be on hold waiting for that information.
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Reference Material
***Results (preclinical): A dose-dependent synergistic activity in inducing apoptosis was observed in multiple AML cell lines when combining imetelstat with venetoclax. In the MOLM-13 cell line, single-agent imetelstat and venetoclax had modest apoptotic activity after 48 hours (22% and 30% respectively), but the combination achieved 88% at 48 hours and nearly 100% at 96 hours. ****
Abstract 1101: Telomerase inhibitor imetelstat in combination with the BCL-2 inhibitor venetoclax enhances apoptosis in vitro and increases survival in vivo in acute myeloid leukemia
Joshua J. Rusbuldt, Leopoldo Luistro, Diana Chin, Melissa Smith, Amy Wong, Margarita Romero, Aleksandra Rizo, Jacqueline Bussolari, Fei Huang and Amy (Kate) Sasser
DOI: 10.1158/1538-7445.AM2017-1101 Published July 2017
I don't believe Geron would be so aggressive unless they were totally confident in Rytelo and its future. The European approvals seem ensured, but one never knows until it happens. We are waiting for some IMpress (AML clinical, Rytelo/imetelstat alone) interim information and progress on TELOMERE (AML, imetelstat with venetoclax clinical) which now appears to be on hold waiting for that information.
==========
Reference Material
***Results (preclinical): A dose-dependent synergistic activity in inducing apoptosis was observed in multiple AML cell lines when combining imetelstat with venetoclax. In the MOLM-13 cell line, single-agent imetelstat and venetoclax had modest apoptotic activity after 48 hours (22% and 30% respectively), but the combination achieved 88% at 48 hours and nearly 100% at 96 hours. ****
Abstract 1101: Telomerase inhibitor imetelstat in combination with the BCL-2 inhibitor venetoclax enhances apoptosis in vitro and increases survival in vivo in acute myeloid leukemia
Joshua J. Rusbuldt, Leopoldo Luistro, Diana Chin, Melissa Smith, Amy Wong, Margarita Romero, Aleksandra Rizo, Jacqueline Bussolari, Fei Huang and Amy (Kate) Sasser
DOI: 10.1158/1538-7445.AM2017-1101 Published July 2017
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LWS
Re: WE ARE APPROVED
Dr. Aleksandra Rizo --- What is she doing now? Does "compound #2" involve any of the novel Vividion (Bayer) molecules that attracted her to her new job (President of Vividion)? Presumably, she still has a keen interest in Rytelo and its future.
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Previous (Aug 7)
Dr. Rizo will be part of Rytelo's future (somehow, someway). I believe she still holds all of her Geron stock options. Also, Vividion Therapeutics, Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a clinical stage biopharmaceutical company that is totally in the USA. Spinoffs and mergers are always possible.
Bayer is in trouble (Roundup for weeds), which is now linked to cancer. The two financially strong European companies that have been mentioned the most as potential European partners are Novo Nordisk (Denmark) and Novartis (Switzerland). Also, the EMA is expected to follow the FDA lead and approve Rytelo soon.
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Previous (Aug 7)
Dr. Rizo will be part of Rytelo's future (somehow, someway). I believe she still holds all of her Geron stock options. Also, Vividion Therapeutics, Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a clinical stage biopharmaceutical company that is totally in the USA. Spinoffs and mergers are always possible.
Bayer is in trouble (Roundup for weeds), which is now linked to cancer. The two financially strong European companies that have been mentioned the most as potential European partners are Novo Nordisk (Denmark) and Novartis (Switzerland). Also, the EMA is expected to follow the FDA lead and approve Rytelo soon.
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LWS
Re: WE ARE APPROVED
At this point in time, approval means FDA + EMA + MHRA/UK all approving to move the Geron PPS over 5 and substantially beyond.
As I see it, we are only partially approved (FDA approval). Certainly, much of the investment community sees it that way. There is every reason to believe that both the EMA and the MHRA/UK will eventually approve Rytelo. Still, there is no guarantee that this will happen. I am hoping that the approvals will come sometime between ASH2024 abstracts (Nov. 5) and ASH2024 (Dec. 7). Obviously, if either agency rejected Rytelo, that would be a major setback for the company and investors. Some believe that the European agencies will hold off to 2025. That is possible.
As I see it, we are only partially approved (FDA approval). Certainly, much of the investment community sees it that way. There is every reason to believe that both the EMA and the MHRA/UK will eventually approve Rytelo. Still, there is no guarantee that this will happen. I am hoping that the approvals will come sometime between ASH2024 abstracts (Nov. 5) and ASH2024 (Dec. 7). Obviously, if either agency rejected Rytelo, that would be a major setback for the company and investors. Some believe that the European agencies will hold off to 2025. That is possible.