Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

[Please keep these entries up to date! See
the updating procedure at the end of this post.
Items that are out of date will be removed.]

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Edits: ABBV; ENTA; EXAS; GILD; MNTA; JNJ (second CRL issued for Xarelto in ACS—entry removed); PRAN; SNY (CLR issued for Lemtrada—entry removed); TEVA (thrice-weekly Copaxone approved—entry removed).


ABBV – HCV program: see ENTA.

ABT – ABSORB bioresorbable stent: Complete ph3 enrollment in US and China 1H14; ph3 in Japan already enrolled. (Note: ABSORB already launched in all mjor countries except US, China, and Japan.)

BMY – Eliquis: see PFE.

ENTA/ABBV – Submit NDA/MAA for 3-DAA HCV regimen: Apr 2Q14. With priority review, FDA decision expected late 2014. Report ph1 data for ABT-493 and ABT-450 (next-gen 2-DAA regimen) at unspecified venue in 2014. (Individual ph1b trials of ABT-493 and ABT-530 are already underway, which must be completed prior to testing the combination.)

ENTA/NVS – EDP-239 ph1b monotherapy trial started by NVS Jun 2013, expected to complete Jun 2014; DDI study of EDP-239 (presumably with DEB025) started by NVS Jul 2013—further details unavailable.

EXAS – FDA advisory panel for Cologuard 3/27/14.

GILD – Sovaldi + Ledipasvir NDA submission 2/10/14; with priority review, FDA decision expected 4Q14. EU MAA submission 1Q14.

GILD – NDAs for “standalone” elvitegravir and “standalone” cobicstat (component drugs in Stribild): FDA issued CRL on 4/29/13; no further details available. (In the EU, elvitegravir is approved as Vitekta and cobicstat is approved as Tybost.)

MNTA – See
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=97142022

NVS – HCV program: see ENTA.

PFE – Eliquis sNDA in primary VTE prevention: PDUFA date 3/15/14; Eliquis sNDA in VTE treatment & secondary prevention: FDA submission 3Q13. (Eliquis was approved for VTE prevention in EU in 2011.)

PRAN - Reach2HD Phase-2 for Huntington's disease: Results Mar 2014?
PRAN - IMAGINE: Phase-2 imaging trial for Alzheimer's disease. Plaque positive prodromal and mild AD. Results?

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Procedure for Updating Calendar

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