FDA is a crock of an organisation. Totally corrupt. It was probably 10 years ago (at least it feels that way) POH stated they were taking the fast-track FDA process approach. There's no such thing. It's all about the dollars. There is no way POH gets anywhere without a large influential partner. It's been a long time trying to get one to commit. I'm dubious.
Ann: FDA meeting provides guidance for TPM/Oxymorphone patch, page-25
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