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Tuesday, September 14, 2010 1:31:40 PM
As for what is holding up the filing of the IND, it sounds like they've gotten input from a prospective partner to change some aspect of the original trial design (see quote below). Also, they apparently 'fixed' some aspects of the trial design.
Varney said - "There are several aspects of this clinical study which we've fixed, and we continue to have discussions around other aspects of the study, in fact we're working with potential strategic partners here to help fund the study, but also to provide us with input into the design and the cost of the study."
So Varney is apparently designing/altering the trial per the prospective partner's requirements. Varney also said - "Importantly, we basically had our own IND package ready for the submission, the only thing we have to add to the IND package is the finalized clinical design protocol."
What could the design changes be? Adding a cohort with once/day dosing, or perhaps the prospective partner wants a larger number of patients per cohort, etc. Either way, having active input from partners at this stage should be a good sign for ultimate partnering interest.
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