Episode 23: A Between the Biotech Waves conversation with Jim Birchenough, Vice Chair of Wells Fargo Biopharmaceutical Inv Banking
Between the Biotech Waves
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Is FDA a Gatekeeper to Biotech?
The one open question is really FDA. We've seen a lot of FDA scrutiny around CMC and manufacturing, particularly for cell therapy and gene therapy. The thing that keeps me up at night is, does FDA turn more hawkish? It's hard to know how wholesome and adequate will the answers be.
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