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Ultimate01

01/28/15 4:03 PM

#89570 RE: cabel #89567

The purpose of their phase Ib was to ensure that Prurisol converted to abacavir and as it turns out it did. With the safety profile of abacavir firmly established they can now proceed without a formal phase I trial. Basically, the FDA is convinced that Prurisol converts to abacavir and future trials can begin.
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BonelessCat

01/28/15 4:47 PM

#89582 RE: cabel #89567

Because with efficacy outcomes the trial would have taken 18 months to 2 years including screening for specific patient criteria, 6 month follow on, final data collection and bottom line results. They would then still need to do an optimization trial for another 18 months to 2 years.