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Re: OFP post# 146238

Tuesday, 04/03/2018 11:18:27 AM

Tuesday, April 03, 2018 11:18:27 AM

Post# of 462632

He had a duty to "take his time" and get it right the first time, to assess the needs to get it right, to assess the pitfalls of the FDA, to submit a clean IND, and to get trials on the timeline HE set. He failed.



Name ANY organization that has filed IND since new FDA "precision medicine" requirements have been set.

Not an apology for M just trying to establish a meaningful context for this comment. Increased "precision" infers a more detailed factual assessment process. Looks to me like the rules/protocols are being rewritten. If any examples/facts exist it would be helpful to review them and in fact any relevant example could add credibility to your statements.
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