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Re: flipper44 post# 231245

Tuesday, 06/04/2019 2:10:06 PM

Tuesday, June 04, 2019 2:10:06 PM

Post# of 694014
Sorry to be the bearer of bad news, but what they did in a Commercial Exhibit Hall at a commercial booth during a scientific meeting packed with potential prescribing customers is a clear attempt at pre-market promotion IMO and was available to potential patients on-line (FACT!) To do so at the stage where you are beginning the official review process when enforcement increase logarithmically is very likely to be considered a serious violation if they were trying to speak to regulators. Even after approval companies to not promote Mechism of Action in any detail beyond the language approved by FDA because there is a lengthy history of enforcement in this area, especially in oncology. Regulators DO NOT attend Commercial Exhibit halls to be educated. They are there to enforce, penalize and monitor their regulations. I can point out literally several dozen times Marnix violated regulation. If FDA was watching, your and my investment may have just been damaged severely by Sunday’s Circus.
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