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Wednesday, June 20, 2018 2:23:56 PM
1. According to May 10, 2017 IPIX press release prurisol interim results were planned at 6 weeks of treatment, presumably with full ITT for the report to make any sense. How the enrollment was going that condition was not met before mid Oct 2017.
2. According to IPIX quarterly reports from 2016-Q3 to 2017-Q2 IPIX was conducting its trial(s) without any overall contract(s) with CRO(s) until Q2 2017 when they entered into contract with minimum anticipated commitment of $6M. Prurisol trial was probably at about 50 % of full enrollment at the end of Q1 2017 and 70 % of target enrollment was reached in May 2017.
Some comments:
A. At 6 weeks pruisols data would have been a poor predictor for final outcome. Useless report.
B. One wonders why the change in the contracting approach in the middle of the biggest trial they had had so far? And how much else did change with the contract? And what were the implications of these possible changes for trial and reporting schedules?
The reason for the big contract could be as simple as IPIX trying to control costs with fixed contract or CRO demanding it. But it also could be IPIX trying to prevent the trial becoming a bigger mess that it already was. If so, the subsequent non-material non-events and delays seem to fit quite well. And communicating about them would have been an embarrassment they rather avoided.
But the above is living in the past. Leo's email seem to indicate and the things with prurisol are finally getting in order. We will see, and soon. I hope.
"I would rather have questions that can't be answered than answers that can't be questioned." Richard P. Feynman
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