Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

[Please keep these entries up to date! See
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Edits: ABBV/ENTA, GILD, PFE.


ABBV—HCV program: see ENTA.

ENTA/ABBV—3-DAA HCV regimen: PDUFA date 12/21/14; EMA decision on MAA expected 1H15 (MAA submitted 5/8/14).

ENTA/ABBV—ABT-493/ABT-530 2-DAA regimen: ENTA decision whether to opt in for US profit sharing is overdue, but the decision may already have been made (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=107024841 ).

GILD—Harvoni in EU: approved by CHMP 9/26/14, awaiting rubber-stamping by EU Commission. (Approved by FDA 10/10/14.)

GILD—Stribild-TAF (i.e. Stribild with TAF substituted for Viread): NDA/MAA submissions 4Q14.

MNTA—See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=104928571

MRK—Keytrada (pembrolizumab) in melanoma: EU MAA accepted for review 6/30/14—EU approval possible in 1H15. (Approved by FDA 9/4/14.)

PFE—Palbociclib AA NDA in breast cancer: PDUFA date 4/13/15.

XOMA—EYEGUARD-B ph3 in Behçet’s uveitis: top-line data 2H14.

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