PDUFA

[jayfish101]

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

[biopearl123]

It means it’s a race

[rccola335]

Last month there were 2 dates on the fda calendar for Geron and BMS - middle June and end of august

[rccola335]

The low risk RS negative is going to be the battle ground - luspstercept did not show much activity - imetelstat should have that market - was disappointed with Uwe Plazbeckers answer on that for the KOL presentation

[biopearl123]

RC listen again, it seemed to me that he misspoke and meant Imetelstat

[jingledsassy]

Excuse me how does We have Bone Marrow Modification factor into a Race.....just thinking out loud....

[rccola335]

is there somewhere to listen to the KOL Q and A again - i can't find it

[biopearl123]

Jingle I meant a race to receive first line designation no question Geron has the upper hand

[biopearl123]

RC try this
https://events.q4inc.com/attendee/256492434

[rccola335]

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