allarity therapeutics inc shares fell 33 to 443 after the company said late friday the us food and drug administration provided it with refusal to file letters regarding a new drug application for dovitinib for thirdline treatment of metastatic renal cell carcinoma the refusal also covers an accompanying premarket approval application for the drpdovitinib companion diagnostic the company said allarity said that the fda determined that the nda submitted dec 22 2021 and the pma application submitted april 2 2021 werent sufficiently complete to permit substantive reviews the fdas refusal to file decision primarily involves submitted clinical trial data that dont enable a conclusion of efficacy based on noninferiority data set allarity said because the pma and nda were filed as related applications the rtfs also apply to the drpdovitinib companion diagnostic the company said allarity said it intends to seek immediate guidance from the fda which may include requesting a type a meeting with the agency to clarify and respond to the issues identified in the rtf letters and seek additional guidance concerning information data and specific deliverables that the agency would require for a resubmitted nda and pma to be deemed complete the company said it expects a new prospective clinical trial would be required to overcome the fdas outstanding objections