I don't believe there is any near term event for CRGN, if there was these guys are tracking it(chart looks good)
Posted by: DewDiligence
In reply to: Aiming4 who wrote msg# 52605
Date:9/24/2007 10:01:47 PM
Post #of 53069
Clinical / Regulatory / Litigation Calendar
[Please keep entries up to date! See updating procedure at the end of this post.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: IDIX (fix error re Tyzeka vs Baraclude trial); IMCL (removed entry—CAIRO2 data out); SNUS (removed entry—TocP data out); VRTX (update re AASLD).
ACHN – See GILD
AMLN – Phase-3 LAR results: 2H07; Byetta monotherapy results any day.
ANOR / AOM.TO – pivotal AMD3100 results any day.
COR – CX717 IND for ADHD IIb trial received by FDA psychiatry division on 9/11/2007, decision due within 30 days.
CRME - IV version of RSD1235: FDA advisory panel 12/11/07.
CYT.TO - Initiated pivotal A-fib trial Oct/06. Complete enrollment 2nd/half 07. Results 2nd half 08.
DDSS – Tramadol NDA: second approvable letter received 5/31/07. New clinical trial likely.
DNA – Avastin sBLA in breast cancer action date: 2/08; Avastin adjuvant CRC interim look Q4 07; Rituxan in Primary Progressive MS Ph III Results Q1 08.
DNDN – Provenge 9902b study: interim analysis (~180 deaths) 2H08; final analysis (360 deaths) 2010.
DORB – OrBec NDA in GVHD: FDA action date was extended in July to 10/21/07.
ELN- Tysabri PDUFA date for Chron's disease 10/15/07
AAB-001 Phase III start in Alzheimer's Disease Q4 07
GILD – Viread NDA submission for HBV: 4Q07.
GILD – GS9190 polymerase inhibitor for HCV: data from phase-1: 3Q07.
GPCB – Satraplatin SPARC trial final OS data: late 2007. (FDA NDA based on PFS data was withdrawn.)
GTCB – ATryn phase-3 for HD in US: report data 4Q07, submit BLA 1Q08.
GTCB – ATryn phase-2 DIC trial by Leo Pharma in Europe/Canada: enrollment complete mid 2008. (First patient enrolled 8/6/07.)
GTCB – Merrimack MM-093: results of phase-2 extension trial in RA: late 2007.
GTOP – Final MyVax results Dec 07.
IDIX – Tyzeka vs Baraclude phase-4 (12 weeks PK): report data 3Q08.
IDIX – Tyzeka ph3 data in decompensated liver disease: enrollment completed 1Q07, reporting date unknown.
IDIX – IDX899 in HIV: Phase-1b monotherapy in treatment-naïve patients (7 days): start dosing Oct 2007; report preliminary results Dec 2007; report full results Feb 2008 at CROI conference. Phase-2 in combination with SoC therapy: begin recruitment in 2008.
IDIX – IDX102/IDX184, 2nd generation HCV nucleosides: submit IND 4Q07.
ISA.TO-European psoriasis P3 results 2008. Phase 2B 6&12 month renal results 2008. Phase II/III Uveitis results 2008.
ITMN – ITMN-191 Phase-1B Start dosing 9/07. Initial PK data from perhaps 1st 3 cohorts: Q1 2008
ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results Late 2008 (72 week treatment period). No interim analysis planned, though monitored for safety.
JNJ – TMC125 for HIV: FDA action date 1/18/08.
LBPFF – see DDSS
MCU/MPH.to - Medicure - MC-1 Lead drug candidate for cardiovascular reperfusion is in PH 3 trial /w 3000 patients.
Expect full enrollment Nov/07 with Data by August /08.
Medivir – ph-1 TMC453350 results in HCV at AASLD 11//07.
Merrimack: see GTCB
MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, interim results mid 2008, trial results in 2009.
NBIX - Indiplon IR PDUFA date December 12, 2007
NBIX - Indiplon IR Product launch, indiplon IR 1Q08
NBIX - NBI-56418 Complete enrollment, 6-month phase 2b endometriosis trial 4Q07
NBIX - NBI-56418 Topline data, 6-month phase 2b endometriosis trial 2Q08
Novocell – see SRDX
NRMX, NRM.TO – European ph-3 Alzhemed trial complete 2008 (N Amer ph-3 failed, as reported 8/26/07).
PHRM – Satraplatin MAA to EMEA to be filed 2/08 following analysis of final OS data.
PPHM -
Bavituximab (anti-viral): phase 1B HCV top-line info released 3/07. Final data at AALSD Nov.
Bavituximab (anti-viral): phase 1 trial in HCV/HIV coinfected patients initiated 7/07.
Bavituximab (anti-cancer): phase 2 breast cancer trial protocol submitted to reg. board 9/07
Bavituximab (anti-cancer): phase 2 lung cancer trial protocol submitted to reg. board 7/07
Bavituximab (anti-cancer): phase 1B solid tumor top-line info released 5/07.
Cotara: phase 2 glioblastoma multiforme Indian trial patient enrollment initiated 6/07.
Cotara: glioblastoma multiforme US trial sites expanded to include MUSC 6/07.
RPRX– Proellex
*Initiate US PII Endometriosis trial (Enrollment Oct 2007)
*One year extension data (Q1 2008)
*Initiate Fibroids Pivotal PIII trials (YE2007)
*Initiate Anemia Pivotal PIII trial(s) (YE2007)
RPRX – Androxal
*FDA Androxal PIII meeting: Oct 15; PR expected 15-31 Oct 2007
*Initiate Pivotal PIII trials (Q4 2007)
RPRX – Other: select alternate Proellex-class compound for advancement into breast cancer studies via potential partner TBA.
SGP – Ph-2 data for SCH 503034 in HCV: 2H07
SPPI – See GPCB.
SRDX - Novocell phase-1/2 trial in type-1 diabetes: late summer 2007 (enrollment complete 8/30/06).
SYMD- Synthemed-Circulatory System Devices Advisory Panel has been scheduled for September 19, 2007 for Repel CV.
TH.TO -Complete enrollment confirmatory TH9507 HIV Associated Lipodystropy trial 3rd qtr/07, final results 1st qtr/08.
UTHR - Viveta (Inhaled Treprostinil for PAH). July 13, 2007 enrollment closed with 235 enrolled. October 5th last patient out +/- 1 week. Early November around AHA top-line results
UTHR - OvaRex. 6/06 IMPACT II completed enrollment. Unblind when 118 recurrences reached in both IMPACT I and II. As of 6/30/07 number of recurrences: IMPACT I-128 IMPACT II-112.
UTHR - Oral Treprostinil (FREEDOM-C). 16 week combination study. Interim analysis possible at 150 (targeting to enroll 300). Enrollment as of 7/30/07 was 115.
UTHR - Oral Treprostinil (FREEDOM-M). 12 week monotherapy study. Interim analysis possible at 90 (targeting to enroll 150). Enrollment as of 7/30/07 was 62.
VRTX – Telaprevir SVR data from PROVE-1 and PROVE-2 at AASLD (11/5/07). The PROVE-1 data will be final, and the PROVE-2 data may be final.
VRUS – Ph-3 Clevudine for HBV: start phase-3 3Q07. Ph-1 R7128 in HCV full data at AASLD (top-line data were reported 9/10/07). New study of R7128 with pegifn and riba: start 4Q07, rpt data at EASL 4/08.
ZGEN – rThrombin FDA response date: 1/17/08 (was extended by 3 months.).
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surf's up......crikey
