I have March 14th as a video conference for ADCOM via various sources on the interwebs.
Does anyone have an objection to this date?
March 14th
Forum rules
- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
- Comments must be civil and on topic
- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
-
- Posts: 128
- Joined: Tue Feb 23, 2016 5:48 pm
Re: March 14th
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 of June 16, 2024; (ii) that FDA is currently planning to hold an advisory committee meeting as part of the NDA review; (iii) that the Company looks forward to working with the FDA to complete the NDA review process on a timely basis; (iv) that the Company continues to expect an imetelstat launch in the United States by the end of the first half of 2024, subject to FDA approval; (v) that imetelstat may alter the underlying drivers of disease and has the potential to demonstrate disease-modifying activity in patients; and (vi) other statements that are not historical facts, constitute forward-looking statements. http://www.businesswire.com/news/home/2 ... r-Risk-MDS
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 of June 16, 2024; (ii) that FDA is currently planning to hold an advisory committee meeting as part of the NDA review; (iii) that the Company looks forward to working with the FDA to complete the NDA review process on a timely basis; (iv) that the Company continues to expect an imetelstat launch in the United States by the end of the first half of 2024, subject to FDA approval; (v) that imetelstat may alter the underlying drivers of disease and has the potential to demonstrate disease-modifying activity in patients; and (vi) other statements that are not historical facts, constitute forward-looking statements. http://www.businesswire.com/news/home/2 ... r-Risk-MDS
-
- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: March 14th
I too have seen the March date mentioned but only by completely unreliable sources. We did see a KOL lecturer make general mention of an April date for ADCOM but I have seen nothing concrete. As of now until we see something trustworthy, ADCOM will probably be in April with anticipated approval the published June date for PDUFA. Keep us posted if you see anything to the contrary.
-
- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: March 14th
Works loud and clear, thanks for posting KT.