I look at the "suggestion" of redirection of the IND into RD instead of ADHD more as a medically correct decision, rather than as a political or a toxicology focused issue.
FDA's role is politically designated guarentor of drug safety. A six foot box of data suggesting artifact in a new class of drugs was considered sufficient to proceed with testing in AD (a terminal neurodegenerative process with no disease modifying therapy available). It would be reasonable to approve IND for testing in RD (a potentially lifesaving/analgesia preserving short term intervention).
If additional safety data can be developed with larger clinical experience in these two settings, why not delay the IND for ADHD and just say, "not ready for prime time in ADHD". I think that is the message from the FDA, whether it is in writing or not.
In retrospect, this seems clear and medically rational and not in the least conspiratorial or dishonest. I think we now know the barriers to introduction of new drugs in healthy individuals with normal life expectancy are higher than previously recognized.
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