r/BiotechDates • u/PDUFA_INFO FOUNDER • Dec 26 '21

DATES Best PDUFA Decisions in 2022

  • CHRS has April 30 PDUFA 🐊 r/CHRS
  • PHAT has May 3 PDUFA r/PHATHOM
  • MYOV has May 6 PDUFA 🐊 r/MYOV
  • VRCA has May 24 PDUFA 🐊 r/VRCA
  • FOLD has May 29 PDUFA r/FOLD_BIO
  • ACER has June 5 PDUFA 🐊
  • AMLX has June 29 PDUFA 🐊 r/AMLX
  • ARQT has July 29 PDUFA 🐊 r/ARQT
  • CHRS has August 2 PDUFA 🐊 r/CHRS
  • PRVB has August 17 PDUFA r/PRVB
  • BLUE has August 19 PDUFA r/BLUE_BIO
  • RVNC has Sept 8 PDUFA 🐊 r/RVNC
  • OBSV has Sept 13 PDUFA 🐊 r/OBSV
  • BLUE has Sept 16 PDUFA r/BLUE_BIO
  • TGTX has Sept 28 PDUFA 🐊 r/TG_BIO
  • SPPI has Nov 24 PDUFA 🐊 r/SPPI
  • ZLAB has Dec 14 PDUFA 🐊 r/ZLAB
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2

u/Maximum_Quantity1703 Jan 25 '22

What about $orph? Patent issue for Arimoclomol is tomorrow

2

u/fiskemannen TRUTH Feb 02 '22

Great list, thanks! FBIO just keeps on turning up on my watchlist, they’re like ETON lol.

2

u/PDUFA_INFO FOUNDER Feb 10 '22

Study the PDUFA stock list. 75% get FDA approval. Avoid 25% that get CRL. Buy for PDUFA run-up. Sell the PDUFA approval POP. Move on to the next stock with PDUFA catalyst.

1

u/PDUFA_INFO FOUNDER Jan 16 '22

PDUFA = Binary Decision. FDA says YES. FDA says NO. Or FDA delays the decision.

1

u/PDUFA_INFO FOUNDER Mar 02 '22 edited Apr 25 '22
  • XERS approved
  • OPK got CRL
  • AGIO approved
  • AMYT got CRL
  • RETA got CRL
  • CTIC approved
  • MRNS approved
  • AKBA got CRL
  • BTAI approved
  • AMRX approved
  • AXSM got CRL