Saturday, December 31, 2016 2:34:44 PM
2016 brought up many question marks regarding Nader’s ability to execute. Starting with what appeared to be a major stumble on the enrollment of the Adjunct P3. It would seem ridiculous that Nader couldn't enroll 30 patients long ago. Is it as simple as that or is there more variables that we are not considering.
Think it through – It became clear to Nader and the board early on that the P3 Adjunct protocol was quite restrictive and the timeline to enroll 300 qualified patients was less than ideal. So, Nader had a choice; spend valuable time renegotiating the protocol with the FDA or go ahead with recruiting 300 patients. Nader along with the consensus of the board opted for a meeting with the FDA. At that juncture recruitment was halted because the Face to Face meetings with the FDA was a review of the entire protocol not just number of patients. I honestly think that Nader and his board, i.e. Maddon and Burger viewed the existing protocol and 300 patient requirements as a deal breaker. What appears to be a lack of execution on Nader’s watch may have been a very wise decision.
So here we are and all eyes are on Nader because 2016 is viewed by many investors as a lost year filled with delays and no progress. The monetary and emotional cost - $25 million in burn and a SP that reflects a year of no new data. Data is what will move the needle and we are now on the cusp of producing such data. Some want Nader out, some have him on a very short leash, others on the inside have total trust because they have all the cards on the table.
To me it is not about Nader’s credentials, it’s do I think he can deliver. One of the most critical factors that will determine the strength of the P3 Adjunct and Mono data is accurate selection and screening to insure enrollment of qualified patients. If we race to the finish line compromising this process it will cost much more than a delay it will cost us our investment. My conversations with Nader indicate unequivocally he has his life invested in Pro-140 and is utilizing the board and KOL’s to make the tough decisions. Reasoning that a person’s credentials are such or because a person hasn’t done it before is a poor reason to assume a person can’t. Character and drive are equally important and Nader has those qualities.
My eyes are on enrollment status and enrollment completion for both P3’s. The science has never been a question mark for me- so produce the data. This is Nader’s complete focus and he will be judged critically in the coming months as to the progress. Let’s not lose sight of how far we have come and how close we are.
Thanks to all for the contributions - your opinions and knowledge are for the most part invaluable. It is my hope that 2017 be one of accelerated progress that clears the path for Pro-140 to improve the lives of those that struggle with HIV.
Happy New Year!
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