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Re: wimuskyfisherman post# 30164

Wednesday, 09/27/2017 5:29:55 PM

Wednesday, September 27, 2017 5:29:55 PM

Post# of 38634
Wimus, I believe you are not considering lobbying and corruption at FDA level.

1- Rexista filing was deemed complete. FDA likely agreed a path with IPCI to just go for the IV and then have the other 2 follow Futher studies. Ipci incompetency, AdComm paid members, FDA burocracy and complacency made the disaster happen.

2- generics being stuck and stonewalled by FDA is object of a myriad of articles and political chatting. So, yes, maybe ipci didn't something properly, but hey, 5 years or more is just an insult. Big pharmaa do know how to protect their creatures. We are talking about billions, so no surprise.

3- the major mistake ipci made relates to the going solo idea for Rexista. Should they had it partnered with Mallinckdrot or Purdue when in phase II...well...likely filing and AdComm a totally different story.