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flipper44

03/18/14 11:44 AM

#6539 RE: Mingusahum #6537

I suggest you might combine section 6.5 licensing parameters within the Guidelines with the FDA-PEI commitment. Combine that with the hospital exemption statutes and reimbursement contingencies and one can easily (IMHO) make the case that FDA and fire-walled NWBO people could legally facilitate the exchange of information for "licensing" purposes. It's just my opinion though.