InvestorsHub Logo
Followers 17
Posts 1580
Boards Moderated 0
Alias Born 02/07/2007

Re: noretreat post# 352

Monday, 12/01/2014 9:36:26 PM

Monday, December 01, 2014 9:36:26 PM

Post# of 1014
Ask him when was the last time management had a meeting with the FDA? They originally had an agreement with the FDA concerning the bioequivalence parameters of SQ vs sublingual apomorphine. The bioequivalence studies showed that CYNAF's formulation was outside those agreed upon parameters so was a meeting conducted to discuss the differences before proceeding to the Phase II & III trials?

What type of FDA communications are normally held for a 505(b)(2) filing? Do they intend on having a meeting before filing the approval application?