TSXV:BTI.H - Post by User
Comment by
Boomskidon Jan 23, 2023 11:02pm
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Post# 35241422
RE:RE:RE:RE:RE:RE:RE:This is why i love this board
RE:RE:RE:RE:RE:RE:RE:This is why i love this board Umm, Craigee Poo, let me explain. It was decided long ago that xB3 does not need to be tested against NHPs. Individual xB3-Payloads may need to be tested against NHPs but that's dependent almost solely on the payload.
Repeat after me in this order.
A) Test in small animals, mice, usually.
B) Submit to FDA or another drug agency for IND or equivalant approval.
C) Test in humans. These tests is called clinical trials.
Bioasis, I contend, has had nothing submitted for IND approval because of bad management. Even the FDA told Bioasis in its response to the xB3-001 pre-IND submission, yes, send it in for IND approval. We may even grant you fast-track status of some sort.
But of course, you and uncle know more these things than the FDA does.
Laffer...!!
jd