I should note that Pascoe's only expert in dealing with the FDA is Troupin who is leaving at the end of May. That is a little concerning to me.
Not sure if that is entirely correct, James. Barbara Troupin in fact does have expertise in dealing with the FDA but its at a Clinical Trial level ( that is my understanding ). She would be the expert in conducting the Clinical Trials and then explaining the trials to the FDA, the reward over the risk, etc.
Barbara Troupin, M.D., M.B.A. has been our Senior Vice President, Chief Medical Officer since December 2014.
Dr. Troupin has held various senior management roles with VIVUS, Inc. in medical affairs and clinical development from 2006 until 2014. In these roles, Dr. Troupin was the lead clinician for the Phase 3 program for Qsymia, was the lead contributor for all medical review of the Qsymia New Drug Application and was the lead medical presenter at the successful Qsymia FDA Advisory Committee Meeting. Prior to this, Dr. Troupin held Medical Director positions at the Profil Institute for Clinical Research and Radiant Research, both contract research organizations.
Dr. Troupin received her M.D. from the University of Pennsylvania School of Medicine and her M.B.A. from the Wharton School of Business.
Apricus believes ( and so do I ) they are not going to have to do more Phase III Clinical Trials on Vitaros in order for the NDA to be reviewed and accepted. If the FDA were to come back and say, listen we need a Phase III trial because of this, then you would be right. Our Clinical Trial expert would be gone and Apricus would have to deal with this then. The only possible loose end that we might have in regards to the requests that they FDA had for further review of the NDA for Vitaros would be the partner transfer. But Apricus now does have real time / real market data in regards to this. Are there any problems because of this in Europe? I believe there is not. Strong Long just recently pointed out a translated tweet from Dr. Hupertan regarding this subject. I think they have data to back them up. Also, there is the precedent of EMA allowing them to label around this.
I believe that at this point in time we need a Regulatory expert. And that might be Brian Dorsey ( not saying he will not get the axe either ) but his resume seems more inline with what is needed at this time.
Senior Vice President, Chief Development Officer 
Brian T. Dorsey has been our Senior Vice President, Chief Development Officer since December 2014.
Mr. Dorsey has served in the pharmaceutical and biotechnology industries for over 20 years where he has provided high-level drug development, regulatory and QC/QA leadership of pharmaceutical candidates from early development to FDA approval. He has held various senior management roles with pharmaceutical companies, most recently at Pernix Therapeutics as Senior Vice President Pharmaceutical Development from April 2013 to September 2014. Mr. Dorsey held managerial positions of increasing responsibility at Somaxon Pharmaceuticals from 2005 to 2013, and before that at Baxter Bioscience and Pfizer Global Research and Development.
Mr. Dorsey received his Master of Science in Executive Leadership and his B.A. in Chemistry from the University of San Diego.
I don't consider myself an expert in this matter but this is what my understanding of the current situation is. Another topic that was asked weeks / months ago was who was in fact responible for negotiating Vitaros USA in-licensing. My thought in regards to this question is that given the recent Promotion - I believe that it was Neil Morton who was responsible for this. Must add that he was also responible of the in-licensing of Fispemifene. |
