CONDENSED CHEAT SHEET – The collected wisdom^ of the thread.
(Links to full comments at the end of this post)
Symbol, Drug, PDUFA Dates: Peter - rkrw
BIIB ELN, Antegren, Nov. 25: YES – YES full approval
SUPG, Orathecin, Nov. 26: NO - NO
UTHR, Remodulin (intravenous formulation), Nov. 30: D/K – D/K Issue is whether fda will require new tests pushing dose pre or post approval
SEPR, Estorra, Dec. 15: YES -YES
EYET PFE, Macugen, Dec. 17: YES - YES
GENZ BIVN, Clofarabine, Dec. 30: D/K – D/K
OSIP DNA Tarceva, Jan. 30: YES - YES
APPX, Abraxane, Jan. 8, 2005: ?? - NO
CYBX, VNS Therapy System, Jan. 31, 2005: NO - NO
DSCO, Surfaxin, Feb. 13, 2005: YES - YES
AMLN, Symlin, March 20, 2005 YES - MAYBE
AMLN, Exenatide, April 30, 2005: YES* - YES
ADLR, Entereg, April 25, 2005: ???** - NO
Clinical Data:
CELG, Revlimid, myelodysplastic syndrome phase II, Dec. 4-7, 2004: GOOD – YES***
AGIX, AGI-1067, atherosclerosis, end of 2004: GOOD??? – “Given noise, how to figure?”
PARS, Dexanabinol, traumatic brain injury phase III, end of 2004: GOOD??? - NO
APHT, Insegia, gastrointestinal cancer phase III, end of 2004: GOOD??? – D/K
ISIS Alifacorsen, Crohn's disease phase III, ulcerative colitis phase II, end of 2004; D/K - NO
CGTK, E2F Decoy, peripheral bypass graft failure phase III, late fourth quarter 2004; E2F Decoy, coronary artery bypass graft failure phase III, early 2005; ??? - NO
CTIC, Xyotax, nonsmall cell lung cancer phase III, first quarter 2005; GOOD - PROBABLY
AXYX, Phenserine, Alzheimer's disease, phase II, first quarter 2005: GOOD??** - PROBABLY
ENCY Thelin, pulmonary arterial hypertension phase III, February 2005: GOOD – YES***
ONXX, BAY 43-9006, renal cancer phase III interim analysis, first half 2005: GOOD – YES***
* This is a function of the editors interpretation so you may want to double check this.
** Editor is unable to divine the nuance of difference between ??? and ?? but has little doubt of the profound significance.
*** By “YES”, rkrw is assuring us there WILL be data.
^ And then there is RH, who has spent much time driving a taxi. Message 20763141
John McCarthy post - Message 20762745
Peter gives the answers - Message 20762886
Rkrw corrects the prof - Message 20763016 |
