Is the path to Food and Drug Administration (FDA)/Investigational New Drug ( IND ) clearance the same as that for other Australian biotechnology companies or global pharmaceutical companies?
Mesoblast continues to work collaboratively with the FDA in our approach to regulatory approvals. Our cells are a well characterised biologic, something that occurs in nature and is not a chemical compound. Since biologic responses among different types of large mammals is quite similar, the results we have obtained with our stem cells in preclinical studies are more likely to be reproducible when tested with patients compared with studies from conventional, synthetic drugs. Moreover, the lack of side effects seen with the stem cells in clinical and preclinical trials strongly supports their ongoing safety in humans, again something that cannot be said for standard drugs. For these reasons, we believe the regulatory path to product clearance and sales may be significantly shorter than for conventional drugs, with clearance for a Phase II for spinal fusion in the US and rapid progression to pivotal trials. This biologic advantage translates to significant savings in time and costs to co
Related Questions
- Is the path to Food and Drug Administration (FDA)/Investigational New Drug ( IND ) clearance the same as that for other Australian biotechnology companies or global pharmaceutical companies?
- Which FDA office may an IRB contact to determine whether an investigational new drug application (IND) or investigational device exemption (IDE) is required for a study of a test article?
- How does the FDA use NCL data when an NCL collaborator submits an Investigational New Drug (IND) filing?
