Relief Therapeutics Holding AG (RLFTF)

[changes_iv]

ONCE GRANTED FAST TRACK DESIGNATION BY THE FDA ——— They said aviptadil is shown as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes while also preventing synthesis of cytokines in the lung. It is a patented formulation of aviptadil (synthetic human Vasoactive Intestinal Polypeptide, VIP), which has been granted FDA fast track designation, FDA emergency use IND authorisation, and an expanded access protocol.

https://www.reuters.com/article/us-health-coronavirus-relief-hldg-idUSKCN2520ED

IF BREAKTHROUGH THERAPY DESIGNATION IS GRANTED WHAT THEN, EXPEDITED APPROVAL???

Fast track and breakthrough therapy are the most similar programs designed to expedite the development of drugs for serious conditions, so it’s easy to get the two mixed up. The most significant difference in these two programs is related to the type of data needed to substantiate the request. Fast track can be granted based on preliminary data, such as activity in a nonclinical model or pharmacological data, or a mechanistic rationale. Breakthrough therapy must use preliminary clinical data, and therefore activity in a nonclinical model or a mechanistic rationale alone would not be sufficient.

https://www.propharmagroup.com/blog/fda-expedited-approvals/