Hank,
Agree fully. Further, if ZONA has a poster presenting those results without a full explanation of how they were obtained, it could well be interpreted by FDA staff as ZONA "promoting" a drug without supporting scientific data, a potential violation of FDA regulations.
However, just because this info does not appear to be in the poster itself, there is no rule or custom to prevent a presenter from offering additional information, such as a technical report, to the people walking by. If I was an FDA staffer responsible for handling ED NDAs, I'd be very concerned if ZONA presented these claims without, at a minimum, a detailed written report describing their protocol.
Even then. a ZONA/SGP technical report would not be considered to be peer-reviewed, so even with that they might get into problems.
I'm sure that at least one FDA staffer will attend the AUA meeting, due to the "Viagra phenomenon."
David |
