Not sure why the IND process is so misunderstood. Tgen is the CRO for this trial. Tgen and Tgen alone will address the FDA at the IND meeting. Tgen handles it from here. They don't have to bribe the FDA but if you understand Dr. Von Hoff's resume, he is well aware of what the FDA requires and in submitting the preIND he is obviously well prepared to answer every question the FDA may have.
It has nothing to do with Von Hoff's influence over the FDA it's his knowledge of what their requirements are. That's why he is the best person for this job.
Thats Funny , No~ Pressure From Us Citizens , Kills Bad Stuff Century Old stuff Matter Of Time all due respect to researchers as they dont get enough credit, god bless em.
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