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Re: None

Tuesday, 12/29/2020 1:47:01 PM

Tuesday, December 29, 2020 1:47:01 PM

Post# of 44690
Lavin Consulting LLC:

“We specialize in providing biostatistics and programming support for the design, conduct, analysis, and reporting of clinical trials involving medical products.”

“To date, our principals have supported the approval or clearance of over 60 products inclusive of drugs, devices, in vitro diagnostics, biologics, and combination products.”

“located in Framingham Massachusetts but we provide support for an international clientele”

On Dr Lavin: “He has served as the Lead Biostatistician for 64 FDA approvals to date including 39 PMAs, 19 NDAs, 4 BLAs, and a de novo and HDE with more pending. These approvals have resulted in >$25B in increased client valuations.

He also advised FDA from 1983 through 2015 on product approvals and public policy matters as a Special Government Employee.”