Positive feedback from the US-FDA following a pre-IND meeting
BIOPHTA was invited to an official hearing by the FDA in order to present the development roadmap of its initial product as well as the planned regulatory pathway. The FDA has validated the plan proposed by BIOPHTA and the agency responded positively to the questions raised by the company.
This significative milestone clears the way for the execution of the preclinical plan to prepare a future IND submission of BIOPHTA’s first-in-human study.