January presentation is impressive to me:
https://s201.q4cdn.com/710325604/files/ ... 1-7-24.pdf
January Presentation
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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
Re: January Presentation
Ryan --- As you and Geron summarize, the list of Imetelstat accomplishments and achievements to date (with huge potentials going forward -- combinations, oral form, new formulations) appears to be overwhelmingly positive.
ODAC will look for medical negatives, but, as far as I can tell, there are no significant Imetelstat problems. These have all been discussed on this board.
March 14th and the comments by the KOLs, patients and other experts will go very well for Imetelstat and Geron (IMHO).
=======================
List of potential negatives:
1/ Shenanigans medically
2/ Safety and Toxicity
3/ Need and Uniqueness
ODAC will look for medical negatives, but, as far as I can tell, there are no significant Imetelstat problems. These have all been discussed on this board.
March 14th and the comments by the KOLs, patients and other experts will go very well for Imetelstat and Geron (IMHO).
=======================
List of potential negatives:
1/ Shenanigans medically
2/ Safety and Toxicity
3/ Need and Uniqueness
Re: January Presentation
Does the ODAC panel announce their recommendation on the day of the meeting?
Re: January Presentation
Ryan -- I do not know anything beyond what has already been posted. As far as I can tell, March 14th and everything leading up to that date will be very public and transparent. This meeting appears to be a joint effort between ODAC and CDER (both parts of the FDA).
============================================================================
Review Material:
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned, and recorded
through an online teleconferencing and/or video conferencing platform. The Committee will
discuss new drug application (NDA) 217779 for imetelstat for injection, submitted by Geron
Corporation. The proposed indication for this product is for the treatment of transfusion-
dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes
who have failed to respond or have lost response to or are ineligible for erythropoiesis-
stimulating agents.
FDA intends to make background material available to the public no later than 2 business
days before the meeting. If FDA is unable to post the background material on its website prior to
the meeting, the background material will be made publicly available on FDA’s website at the
time of the advisory committee meeting. Background material and the link to the online
teleconference and/or video conference meeting will be available at
https://www.fda.gov/AdvisoryCommittees/ ... efault.htm.
Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles
an in-person advisory committee meeting.
==============================================
ODAC & CDER ---- Webcast of March 14th ODAC (Imetelstat) meeting
Webcast Information
CDER plans to provide a free of charge, live webcast of the upcoming advisory committee meeting (ODAC, March 14). If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available no later than two (2) business days before the meeting in the Event Materials section of this web page.
CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
Contact Information
LaToya Bonner, PharmD, MBA
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993-0002
Phone: 301-796-2894
Email: ODAC@fda.hhs.gov
================================
FROM CDER :
NO. 10. Imetelstat (most anticipated & important new drugs of 2024)
▶ Company: Geron
▶ Indication: Lower risk myelodysplastic syndromes (MDS)
▶ Status: PDUFA date of 16 June 2024
+++++++++++++++++++++++++++++++++++++++++++++++++
The Center for Drug Evaluation and Research (CDER) is a division of the U.S. Food and Drug Administration (FDA) that regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs . CDER evaluates new drugs before they can be sold. CDER is the lead Center for regulation of human drugs that are regulated by FDA under the authority of the Federal Food Drug and Cosmetic (FD&C) Act. Biological products are covered by the Center for Biologics Evaluation and Research
Top
============================================================================
Review Material:
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned, and recorded
through an online teleconferencing and/or video conferencing platform. The Committee will
discuss new drug application (NDA) 217779 for imetelstat for injection, submitted by Geron
Corporation. The proposed indication for this product is for the treatment of transfusion-
dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes
who have failed to respond or have lost response to or are ineligible for erythropoiesis-
stimulating agents.
FDA intends to make background material available to the public no later than 2 business
days before the meeting. If FDA is unable to post the background material on its website prior to
the meeting, the background material will be made publicly available on FDA’s website at the
time of the advisory committee meeting. Background material and the link to the online
teleconference and/or video conference meeting will be available at
https://www.fda.gov/AdvisoryCommittees/ ... efault.htm.
Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles
an in-person advisory committee meeting.
==============================================
ODAC & CDER ---- Webcast of March 14th ODAC (Imetelstat) meeting
Webcast Information
CDER plans to provide a free of charge, live webcast of the upcoming advisory committee meeting (ODAC, March 14). If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available no later than two (2) business days before the meeting in the Event Materials section of this web page.
CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
Contact Information
LaToya Bonner, PharmD, MBA
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993-0002
Phone: 301-796-2894
Email: ODAC@fda.hhs.gov
================================
FROM CDER :
NO. 10. Imetelstat (most anticipated & important new drugs of 2024)
▶ Company: Geron
▶ Indication: Lower risk myelodysplastic syndromes (MDS)
▶ Status: PDUFA date of 16 June 2024
+++++++++++++++++++++++++++++++++++++++++++++++++
The Center for Drug Evaluation and Research (CDER) is a division of the U.S. Food and Drug Administration (FDA) that regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs . CDER evaluates new drugs before they can be sold. CDER is the lead Center for regulation of human drugs that are regulated by FDA under the authority of the Federal Food Drug and Cosmetic (FD&C) Act. Biological products are covered by the Center for Biologics Evaluation and Research
Top
-
biopearl123
- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: January Presentation
Ryan, the ODAC votes with a non binding recommendation to the FDA. The voting count is made public but it may not be on the same day especially if the committee needs time to deliberate or asks for more info. We should get a sense how the vote will go during the proceedings. The FDA usually follows the committee’s recommendations. There have been split votes (recall Alzeheimer’s meds). The published PDUFA is a guideline and I think it is reasonable to assume approval (or not) will be well before the June date.