I'm going to give my opinion on this matter. Since the collapse of RIGS in the 1990's and under David Bupp's direction, they approached the FDA with the utmost caution. Before conducting their trials, they would meet with the FDA to discuss everything to death before proceeding. It drove long term investors crazy because everything took so long to develop. The approach to the trials neo3-05 and neo3-09 were not treated any different.
As Mark Pykett (CEO) explained in one of the latest CC's..
So in my opinion based on the facts presented, the trial is not flawed. I would like to know how the FDA can reject a drug for which they gave their guidance and recommandations in how the trails are to be conducted...
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