RE: RE: Commercialization14 Mar 2023 12:23
From Liberum's note today "This small delay comes after some minor non-clinical questions were raised, and confirmatory data requested by the FDA. The company expects to fully respond and submit requested data to the FDA by the end of the month. We have spoken to management and remain highly confident of US approval. In fact, given that the only issues flagged by the FDA were minor, we are even more confident....We remain buyers with a target price of 121p....We are now in the final stages of the review, and the FDA has come back with additional questions on MED3000 and has asked for some minor non-clinical confirmatory data (which should take a matter of weeks to respond). Futura aims to respond by the end of this month, but it does mean that a decision on FDA regulatory approval is now expected in Q2 2023 (vs. by end of Q1 2023 previously). We have spoken to management and remain confident of FDA approval. The
additional questions do not seem related to the clinical data but to nonclinical data that can be generated both quickly and inexpensively. Given the company believes it is ready to submit responses by the end of March, the issues look easily surmountable. The issues flagged were, in our view, minor, and our confidence in approval remains intact, if not strengthened. This confidence is founded in the fact that the European regulatory agency has already approved MED3000, the excellent efficacy and safety data published to date, and that Futura has had six meetings now with the FDA, the latest in late February, so we feel that if there were any major issues that would have been flagged by now. "