Ortho Regenerative Technologies Announces Successful Type A Meeting With U.S. FDA on CMC Elements For Which More Information Was Required to Clear IND Clinical Hold
MONTREAL, Oct. 6, 2021 /PRNewswire/ - Ortho Regenerative Technologies Inc. (CSE: ORTH) (OTC: ORTIF) ("Ortho" or the "Company"), a clinical stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, today announced a successful Type A meeting with the U.S. Food and Drug Administration ("FDA").
- MONTREAL, Oct. 6, 2021 /PRNewswire/ - Ortho Regenerative Technologies Inc. (CSE: ORTH) (OTC: ORTIF) ("Ortho" or the "Company"), a clinical stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, today announced a successful Type A meeting with the U.S. Food and Drug Administration ("FDA").
- In a letter received on October 1, 2021, related to two pending CMC elements for which more information was required, the FDA cleared the small-molecule impurity testing issue, with Ortho committing to using a GC-LC-MS testing method.
- "Today we achieved a mutual agreement with the FDA during a collaborative Type-A meeting" said Claude LeDuc, President and CEO of Ortho.
- "Ortho Regenerative Technologies is committing to performing the requested recovery study using one of the suggested standard reference material.