PDUFA
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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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- Posts: 128
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PDUFA
This suddenly appeared on my Google calendar. What does it mean for Geron?
GERN GERON CORP PDUFA
2023-08-28 Bristol-Myers Squibb Company, or BMS, has announced that the FDA accepted the supplemental Biologics License Application, or sBLA, for luspatercept for Priority Review in first-line LR-MDS and set a Prescription Drug User Fee Act (PDUFA) review date of August 28, 2023. https://www.sec.gov/Archives/edgar/data ... 230331.htm
GERN GERON CORP PDUFA
2023-08-28 Bristol-Myers Squibb Company, or BMS, has announced that the FDA accepted the supplemental Biologics License Application, or sBLA, for luspatercept for Priority Review in first-line LR-MDS and set a Prescription Drug User Fee Act (PDUFA) review date of August 28, 2023. https://www.sec.gov/Archives/edgar/data ... 230331.htm
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Re: PDUFA
RC listen again, it seemed to me that he misspoke and meant Imetelstat
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Re: PDUFA
Excuse me how does We have Bone Marrow Modification factor into a Race.....just thinking out loud....
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- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: PDUFA
Jingle I meant a race to receive first line designation no question Geron has the upper hand
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- Posts: 1670
- Joined: Fri Jul 20, 2018 5:13 pm
Re: PDUFA
RC try this
https://events.q4inc.com/attendee/256492434
https://events.q4inc.com/attendee/256492434
Re: PDUFA
what I hear (at the 48 minute mark) - this is pending approval and guidance but he says people would lean to Luspat for RS + and - due to ease of administration - for low transfer burden - if they were high transfer burden then he would look to imetelstat - I was disappointed with this response due to Luspat showing little to no effect with RS-
If i had MDS (smoldering bone hematologic CA) I would want a drug that could modify the disease rather than cover up the anemia - the FDA will be hammering this out this summer
If i had MDS (smoldering bone hematologic CA) I would want a drug that could modify the disease rather than cover up the anemia - the FDA will be hammering this out this summer