The FDA has provided Allarity Therapeutics Inc (NASDAQ:ALLR) with a Refusal to File (RTF) letter for a marketing application for dovitinib for the third-line treatment of metastatic renal cell carcinoma (mRCC).
- The refusal also covers an accompanying pre-market approval (PMA) application for the DRP-Dovitinib companion diagnostic.
- The FDA determined that the applications submitted were not sufficiently complete to permit substantive reviews upon preliminary review.
- In the letter regarding the marketing application, the FDA said that the submitted clinical trial data do not conclude efficacy based on non-inferiority data set.
- In December, Allarity' submitted its first regulatory application for marketing approval.
- Allarity intends to seek immediate guidance from the FDA, which potentially includes requesting a Type A meeting to clarify and respond to the issues identified in the RTF letters and seek additional guidance.
- The Company anticipates that a new prospective clinical trial will be required to overcome the FDA's outstanding objections.
- Price Action: ALLR shares closed at $6.59 on Friday.
