Synaptogenix Inc (SNPX)

[Whatsupp]

This was explained months ago. The rules for determining bio-similar drugs does not require a start over. Also and Adaptive trial does not change any requirements for biosimilar approval.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=131017400

Isn’t that different from the way most drugs are approved?

Yes. The process is referred to by FDA as an “abbreviated licensure pathway.” It was created by the Biologics Price Competition and Innovation Act of 2009, passed as a provision of the Affordable Care Act.

Although the approval process is abbreviated, the process still requires an extensive amount of data to be submitted with the application, Christl noted on July 12. This data emerges through a different development process than the data used in standalone drug applications.

Standalone drugs move through three phases of clinical trial testing on their way to approval. Phase I is typically a safety study in a small number of people, and Phases II and III test the effectiveness and safety of the drug in a larger patient population.

For biosimilars, because the bulk of the data comes through analytical studies supporting the similarity of the drug to the reference biologic, the clinical trial phase starts at Phase III.