Update
$Inhibikase Therapeutics(IKT.US$ Inhibikase Reports Preliminary Outcomes Of Pre-NDA Meeting With FDA On Pathway For Approval For IkT-001Pro In Blood And Gastrointestinal Cancers; Says Given Specific Guidance On Manufacturing Requirements Necessary To Complete NDA![]()
Disclaimer: Community is offered by Moomoo Technologies Inc. and is for educational purposes only.
Read more
Comment
Sign in to post a comment
TrytosaveabitOP : We were pleased with the discussion we had with the FDA as we begin the process of building our first NDA package needed for approval," said Dr. Milton Werner, President and Chief Executive Officer of Inhibikase. "Our bioequivalence studies were presented to the FDA and we were given specific guidance on the manufacturing requirements necessary to complete the NDA. The FDA acknowledged that the appropriate approval path appears to be 505(b)(2) and we plan to seek all 11 indications for which imatinib mesylate has been approved, including its use in children. There is significant work ahead of us as we discuss these details with potential commercialization partners and carry out the work needed for the NDA submission," noted Dr. Werner.