Examples of Full approval in a sentence
Deciphera Press Release: FDA Grants Full Approval of Deciphera Pharmaceuticals’ QINLOCK™ (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor [online] May 15, 2020.
Rain, either directly or through one or more of its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to receive at least three (3) Full Approval for use in the Field and to maintain the same during the Term in each of the following countries/region: the United States of America, each Major European Country, and one country outside the United States of America and EU.
In addition, PharmaMar will also provide to Jazz, prior to database lock for cross-trial comparison of the Atlantis Trial, the pre-specified statistical analysis plan for cross-trial comparison of the treatment arm of the Atlantis Trial with the monotherapy data from PharmaMar’s Clinical Trial known as PM1183-B-005-14 (i.e. the “basket trial”), which comparison will be submitted to the FDA to support the granting of Full Approval.
Par shall have the right to terminate this Agreement on ninety days’ written notice to Alfacell if (a) the Product for the Primary UMM Indication shall not obtain Full Approval on or before January 1, 2012, or (b) the Product for the Primary UMM Indication receives a Not Approvable communication from the FDA.
Bojangles’ will operate as an independent, privately-held company and will remain based in Charlotte, N.C.