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Sunday, January 17, 2010 4:36:51 PM
Provided there is no 'safety signal', Phase II testing would be allowed.
The problem is, I don't think we know what the likelihood is of clean toxicology results, particularly if the FDA asks for 70X the clinical dose.
My sense is that the CX-717 tox trials were botched: if the problems were due to a post-mortem artifact as cor claims, they should have redone the trials prior to submitting the data to the FDA. Is the toxicology work Tran's responsability? Hopefully, he will get it right on the first try.
What do you think the up-fronts on an RD outlicencing might be? Is there a chance that these up-fronts will be sufficient to complete a phase II ADHD trial?
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