RE:RE:Raymond JamesJudging from the cantechletter, it would appear that Raymond James Rahul Sarugasa does not know the difference between an NDA and a BLA (biological license application), which ONCY's biologic pelarerep would be submitted under to request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2).
Furthermore, Raymond James Sarugasa clearly doesn't understand the Orphan/Rare drug approval process and the shortened timelines associated with FDA review and approval. Clearly they have no idea of the Accelerated Approval process.
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber