PDUFA Date definition

PDUFA Date means the earlier of (i) the date immediately following the date upon which the Corporation first publicly announces the outcome of the review by the U.S. Food and Drug Administration of the Corporation’s new drug application of its product candidate known as KP415, and (ii) March 2, 2021.

PDUFA Date means the date as set by the FDA for response to the NDA pursuant to the Prescription Drug User Fee Act of 1992, as amended.

PDUFA Date means the user fee goal date set forth in a written filing communication from the FDA with respect to the Borrower’s New Drug Application for [* * *].

Examples of PDUFA Date in a sentence

• Prescription Drug User Fee Act (PDUFA) Date means the date the Food and Drug Administration (FDA) are expected to deliver their decision whether an approval or denial has been granted to a new drug application (NDA) or biologics license application (BLA).

• For example, the first architectural sheet is A-1 and the second architectural sheet is A-2.

• Each share of Series B-2 Preferred Stock shall be convertible, at any time and from time to time from and after the PDUFA Date, at the option of the Holder thereof, into a number of shares of Common Stock equal to the Conversion Ratio.

• Key Catalysts in Pain & CINV Franchises HTX-011 for Postoperative Pain CINVANTI™ (HTX-019) for CINV SUSTOL® for CINV Top-line results abdominoplasty NDA submission 2017 net sales guidance increased: $25M - $30M Phase 2 program in nerve block initiated NDA PDUFA Date Nov.

• Either Party shall have the right to terminate this Agreement (i) [***] ([***]) days after the PDUFA Date if Relypsa receives a [***] from the FDA that is [***] within [***] ([***]) months from the PDUFA Date, or (ii) if Relypsa has not obtained regulatory approval from the FDA to sell the Product in the Territory on or before [***].

More Definitions of PDUFA Date

PDUFA Date means the initial date, as may be adjusted for reason other than due to [***], which is the deadline for the FDA to complete review of an NDA for a particular Product.

PDUFA Date means the date by which the FDA will review the Pacritinib NDA and render a decision thereon.

PDUFA Date means the date by which the FDA will review the Pacritinib NDA and render a decisionthereon.

PDUFA Date the user fee goal date that is set forth in a filing communication or other written correspondence from FDA indicating that the Borrower’s BLA for the Product has been accepted for substantive review.

PDUFA Date means the date on which the US Food and Drug Administration (“FDA”) provides as the date on which the FDA will make a determination whether the Iroko Product may be marketed in the United States, such date to be communicated by Iroko to Ventiv as soon as such date is provided by the FDA.

PDUFA Date means October 21, 2015.

PDUFA Date means the first date on which the FDA accepts, rejects or provides a complete response letter with respect to the New Drug Application for VIAject, as the same may be accelerated or extended from time to time. For the avoidance of doubt, if the FDA issues a complete response letter on or about the PDUFA Date and, thereafter, a new FDA action date is set, any such new action date shall not be considered a PDUFA Date for purposes of this Warrant.